Clinical trial NCT03261193
Conditions: Pain, Postoperative
Keywords: quadratus lumborum block post-operative pain cesarean section pain analgesia nerve block
Sponsor: Nicholas Schott
Start date: 2017-09-05; Completion date: 2022-11-11
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparison of standard post-operative cesarean surgery pain management with regional post-op pain control.

Detailed description:
The purpose of this trial is to determine the efficacy of a postoperative analgesia strategy that incorporates quadratus lumborum block (QLB) in conjunction with a multi-modal post-cesarean analgesia strategy. The investigators hypothesize that QLB will provide superior post-cesarean analgesia compared to the current standard of care, multi-modal analgesia.

Thus, analgesia following cesarean section using QLB compared to the current standard of care alone will be further investigated. Current practice for cesarean surgical intervention consists of multi-modal analgesia (i.e., Intrathecal morphine (ITM) and scheduled post-operative non-opioid oral analgesics, with oral opioid analgesics reserved for breakthrough pain).

Investigators will measure side-effects associated with each strategy: Standard of care methods consisting of intrathecal morphine (ITM) plus scheduled non-opioid analgesics in conjunction with prn opioid analgesics for breakthrough pain will be utilized for both. The experimental treatment arm will entail standard of care in addition to QLB. The sham comparator will entail standard of care in addition to QLB with saline.

For each strategy, we will measure and model associated economic ramifications; such factors will include drug costs, procedure costs, and costs associated with length of stay and re-admissions.

The quadratus lumborum block (QLB) is similar to the transversus abdominis plane (TAP) block, but differs slightly in regards to the anatomical region where local anesthetic is injected. Since the quadratus lumborum (QL) is more posteriorly located, it theoretically confers greater safety due to enhanced visualization. The TAP block has been studied extensively for post-cesarean delivery pain, consistently showing that it is not superior to ITM for post-operative analgesia; however, it may prove to be helpful in patients with breakthrough pain despite the use of ITM, or in patients who were unable to receive ITM (e.g. general anesthesia for cesarean, contraindications to neuraxial morphine). Thus, ITM is superior to TAP alone for post-cesarean analgesia, but it is associated with a dose-dependent increased risk for opioid related side effects. In 2015, Blanco et. al. published a study specifically using the QLB for postoperative pain after cesarean delivery. In this study, they compared a true QLB to a sham QLB all in patients who did not receive ITM, and found that the QLB provided improved pain control and decreased the need for post-operative opioids. Another study in 2016 demonstrated that the QLB is superior to the TAP block in regards to decreasing post-operative pain following c-section. Unfortunately, neither study compared the QLB to ITM (part of the current gold standard for post-cesarean delivery pain, multimodal analgesia).

The gap in knowledge regarding the utility of QLB as part of a multimodal analgesic approach including ITM for cesarean section warrants further investigation. Clinicians are constantly searching for methods to provide patients with the most effective medical interventions that provide maximal benefit and minimal harm. Post-operative pain control following cesarean delivery is an area that is important to patients and to providers, and the introduction of the QLB for this purpose has the potential to improve analgesic benefit.

Arms: arm 1: Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section. arm 2: Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.
Interventions: intervention 1: ITM + Sham QLB intervention 2: ITM + Bupivacaine QLB
Intervention descriptions: intervention 1: Sham subcutaneous non-anesthetic infiltration with saline intervention 2: QL plane block with local anesthesia

Protocol documents:
ICF_005.pdf: 
 
 
 
 
 
 
 
 
STUDY TITLE: Quadratus Lumborum Block versus Intrathecal Morphine for Postoperative Pain 
Control after Cesarean Delivery 
 
Principal Investigator: Nicholas J. Schott, MD 
Source of Support: UPMC Department of Anesthesiology and Perioperative Medicine 
NCT: 03261193 
Date of Approval: 06/18/2019 
 


University of Pittsburgh STUDY19050322 
Approved: 6/18/2019 
Expires: 6/17/2020 
 
 
 
CONSENT TO ACT AS A PARTICIPANT IN A RESEARCH STUDY AND 
AUTHORIZATION TO DISCLOSE PROTECTED HEALTH INFORMATION 
FOR A RESEARCH STUDY 
 
Title: Quadratus Lumborum Block versus Intrathecal Morphine for Postoperative 
Pain Control after Cesarean Delivery 
 
Investigator: 
Dr. Nicholas J. Schott, M.D. 
300 Halket Street, Suite 3510 
Pittsburgh, PA 15213 
T (412) 354-6023 
 
Source of Support: UPMC Department of Anesthesiology 
 
Why are you being asked to participate in this research? 
 
You are being asked to participate in this research study because you are at least 
18 years of age and scheduled to undergo a cesarean section. Before agreeing to 
be in this study, it is important that you understand that studies like this include 
only people who choose to take part. An investigator will explain the research study 
to you. Your participation is voluntary; you can choose not to participate. Please 
read this informed consent carefully and ask about any words or information that 
you do not clearly understand. It tells you what you need to know about this 
research study. If you agree to take part in this study, you need to sign this form. 
Your signature means that you have been told about this study, its risks, and that 
you want to take part in this study. 
Why is this research study being done? 
 
We are trying to improve the post-operative management of patients undergoing 
cesarean delivery. Under the current standard of care, spinal anesthetics are 
performed with morphine typically given into the intrathecal (spinal) space during 
the procedure. While this medication typically provides good pain relief for many 
hours after surgery, it is also associated with several unwanted side effects such as 
nausea, vomiting, pruritus (itching), and sedation. The ultrasound-guided 
quadratus lumborum block (QLB) is a relatively newer technique that was first 
reported in 2007. It has already been shown in studies to provide good pain relief 
following cesarean sections compared to placebo, but has yet to be compared to 
the current standard of care, intrathecal morphine. The hope of this study is to 
determine if the QLB can provide comparable or superior pain relief compared to 
intrathecal morphine, while at the same time also decreasing the unwanted side 
effects associated with intrathecal morphine. 
 
While previous studies have demonstrated that the quadratus lumborum block 
(QLB) provides good pain relief after cesarean delivery compared to placebo, there 
have yet to be any studies directly comparing it to the current standard of care, 
intrathecal morphine. Therefore, it is currently unknown if the QLB will provide the 
 
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same, better, or worse pain control compared to intrathecal morphine. We suspect 
that the pain control experienced will be similar or maybe better, but cannot say for 
sure. It is therefore possible that if you are randomly assigned to the QLB only 
group, your pain relief may not be as good as it otherwise would have been. To 
compensate for this, additional pain medications will be available to you if needed, 
regardless of which group you are assigned to. If you randomly get assigned to the 
QLB plus intrathecal morphine group, you will likely have better pain control than 
what is routine. 
 
Who can I talk to if I have questions? 
 
Your physician is involved as an investigator in this research study. Before agreeing 
to participate, or at any time during your study participation, you may discuss your 
care with another doctor who is not associated with this research study. You are not 
under any obligation to participate in any research study offered by your physician. 
If you have questions, concerns, or complaints, or think that the research has hurt 
you, you should contact the principal investigator – Dr. Nicholas J. Schott, M.D. at 
(412) 354-6016, or call (412) 354-4148 to speak with the anesthesia provider on 
call. 
 
If you have any questions about your rights as a research subject or wish to talk to 
someone other the research team, please call the University of Pittsburgh Human 
Subjects Protection Advocate toll-free at 866-212-2668. Please use this number if 
you feel that your questions, concerns, or complaints are not being answered by 
the research team, you have questions about your rights as a research subject or 
want to get information or provide input about this research. 
 
How long will the research last? 
Your involvement in this research study is expected to last for about 6 weeks after 
the completion of your cesarean delivery. The entire study is anticipated to last 
approximately three to six months. 
 
How many people will be studied? 
We anticipate that approximately 60 women will be included in this research study 
and that the involvement of each individual will be only during their current 
hospitalization for delivery. All participants will be taken from Magee Women’s 
Hospital of UPMC. 
 
What happens in this research study? 
If you agree to participate in this study, you will be randomly assigned (by every 
other enrollment to treatment group) to one of two groups: 
• 
Intrathecal (spinal) Morphine Only – This group will receive intrathecal 
(spinal) morphine to help with post-operative pain control as is the current 
standard of care. 
 
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• 
Both Intrathecal Morphine and QLBs – This group will receive both 
intrathecal morphine and left and right sided QLBs to help with post- 
operative pain control. 
Regardless of which group you are assigned to, follow-up assessments will occur: 
• 
During the next 48 hours after your surgery. You will be followed-up with at 
15 minutes, 30 minutes, 45 minutes, 1 hour, 4 hours, 24 hours, and 48 
hours after your procedure. 
• 
Items that will be assessed at these time intervals include: 
o Your verbalized pain scores from 0-10 at rest and with movement 
o The amount and types of postoperative pain medications you require 
o The time you first request extra opioid medications 
o Your vital signs 
o Measurement scores to assess for side effects including nausea, 
vomiting, pruritus (itching), and sedation 
o Presence or absence of signs of local anesthetic toxicity including 
perioral numbness, ringing in your ears, and/or metallic taste in your 
mouth 
o Whether or not you are able to successfully breast feed, and what 
effect, if any, pain has on your success (assessed at 24 hour follow-up 
only) 
o Quality of life assessment (at 48 hour follow-up only) 
• 
Items that will be assessed 6 weeks after your cesearean delivery: 
o The severity of your pain and any impact it might have on daily 
functioning 
o Your verbalized pain scores from 0-10 at rest and with movement 
o The amount and types of pain medications you currently require 
o A postnantal depression outcome scale 
After the assessments at 6 weeks, your involvement in this study will be complete. 
 
The medications utilized for the Quadratus Lumborum block will include dilute 
bupivacaine. Bupivacaine is a FDA approved local anesthetic for nerve block 
procedures. A total of 40mL of 0.25% Bupivacaine will be used with 20mL allocated 
per surgical side which is a standard dose for quadratus lumborum pain block. 
Potential health information that will be used and/or disclosed: 
• 
Your age, gender, race, height, weight, body mass index, ASA classification 
(measure of your level of health according to the American Society of 
Anesthesiologists), number of prior pregnancies, and gestational age 
• 
The number of cesarean deliveries that you have had in the past and the 
reason for your current cesarean delivery 
• 
Any medical comorbidities (other medical problems) that you may have 
including any history of chronic opioid use 
• 
Your verbalized pain scores from 0-10 at rest and with movement 
• 
The amount and types of postoperative pain medications you require 
 
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• 
The time you first request extra opioid medications 
• 
Your vital signs 
• 
Measurement scores to assess for side effects including nausea, vomiting, 
pruritus (itching), and sedation 
• 
Presence or absence of signs of local anesthetic toxicity including perioral 
numbness, ringing in your ears, and/or metallic taste in your mouth 
• 
Whether or not you are able to successfully breast feed, and what effect, if 
any, pain has on your success 
What happens if I say no, I do not want to be in this research? 
Participation in this research is voluntary. You may decide not to take part in the 
research and it will not negatively impact your care in any way. Refusal to 
participate will involve no penalty or loss of benefits to which you are otherwise 
entitled. This is not a treatment study. Your alternative is not to participate. Should 
you not participate, the spinal anesthetic for your cesarean delivery will be placed 
and dosed in the usual fashion, and no quadratus lumborum block will be 
performed. You are not under any obligation to participate in any research study 
offered by your doctor. 
 
What happens if I say yes, but I change my mind later? 
You can, at any time, withdraw from this research study. You can also 
withdraw your authorization for us to use your identifiable medical information for 
the purposes described above. This means that you will also be withdrawn from 
further participation in this research study. Any identifiable research or medical 
information obtained as part of this study prior to the date that you withdrew your 
consent will continue to be used and disclosed by the investigators for the purposes 
described above. Should you decide to withdrawal, any information already 
obtained will still be used in the study, but no new information will be obtained. 
Should any new findings develop during the course of the research that may be 
related to your willingness to continue participation, it will be provided to you in a 
timely manner. To formally withdraw from this research study, you should 
provide a written and dated notice of this decision to the principal investigator of 
this research study at the address listed on the first page of this form. Your 
decision to withdraw your consent for participation in this research study will 
have no effect on your current or future medical care at a UPMC hospital or 
affiliated health care provider or your current or future relationship with a health 
care insurance provider. 
 
 
 
 
What are the study risks? 
Risks associated with screening procedures and access to private health 
information includes: 
• 
Loss of confidentiality: 
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o Access to health information 
o Screening procedures 
o Follow-up 
Special care will be taken to ensure anonymity in this study and only a study 
number will be used to identify you. Only necessary information will be collected 
and any questions asked will be done so in a respectful manner in a private area. 
Should any unforeseen loss of confidentiality occur, you will be informed in a timely 
manner. Although every reasonable effort has been taken to de-identify your 
research information, confidentiality cannot be guaranteed and it is possible that 
re-identification of research data may occur. 
 
Risks associated with intrathecal morphine (ITM) include: 
• 
Nausea and/or vomiting 
• 
Itching (pruritus) 
• 
Sedation 
The above are known side effects associated with intrathecal morphine. These 
effects may be experienced by anyone assigned to either of the two groups that will 
receive intrathecal morphine. 
 
Risks associated with the quadratus lumborum block (QLB) include: 
• 
Bleeding 
• 
Infection 
• 
Damage to surrounding structures 
There is a very low risk of experiencing one or more of the possible side effects 
above if you are in a group who receives a QLB. These risks are minimized by 
performing the procedure in a sterile fashion, ensuring appropriate dosing, and 
using an ultrasound machine which allows us to directly visualize where we are 
going. You will likely experience no discomfort while having the left and right QLBs 
performed because you will still be under the effects of spinal anesthesia and numb 
in those areas. As with any experimental procedure, there may be adverse events 
or side effects that are currently unknown and certain of these unknown risks could 
be permanent, severe or life-threatening. 
 
Risks associated with bupivacaine include: 
• 
Maternal: 
o Restlessness 
o Anxiety 
o Dizziness 
o Tinnitus 
o Blurred vision 
o Tremors 
o Depression of the myocardium: decreased cardiac output, heartblock, 
hypotension, bradycardia, ventricular arrhythmias 
 
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o Allergic type reactions. 
• 
Newborn: 
o There is a possibility that drugs used during the standard of care and 
research pain control procedures may be found and excreted in small 
quantities in the breast milk and these typically do not affect the baby. 
There is a chance your baby could experience some sleepiness due to 
these medications 
Risks associated with follow-up pain and breastfeeding questions and 
assessments include: 
• 
Inconvenience 
• 
Frustration or embarrassment (if breastfeeding is unsuccessful).Loss of 
confidentiality 
• 
Although every reasonable effort has been taken to de-identify your research 
information, confidentiality cannot be guaranteed and it is possible that re- 
identification of research data may occur. 
• 
As with any experimental procedure, there may be adverse events or side 
effects that are currently unknown and certain of these unknown risks could 
be permanent, severe or life-threatening. 
There may be some inconvenience to you associated with the follow-up that is 
planned for this study at 15 min, 30 min, 45 min, 1 hr, 4 hrs, 24 hrs, 48 hrs, and 6 
weeks after your procedure. This is minimized by keeping the follow-up simple, and 
only approximately 2 minutes of your time should be required to answer a few 
simple questions at each time interval. Again, there is a small risk for loss of 
confidentiality which will be minimized as described above. 
 
What are the benefits of the study? 
We cannot promise any benefits to you or others from your taking part in this 
research. However, possible benefits from participation may include improved post- 
operative pain control, decreased need for post-operative pain medications, and 
decreased incidence of opioid related side effects such as nausea, vomiting, pruritus 
(itching), and sedation. 
 
 
 
Will my information be kept confidential? 
Your identity and medical records and data related to this study will be kept 
confidential, except as required by law and except for inspections by the University 
of Pittsburgh Research Conduct and Compliance Office. Once enrolled, you will be 
given a research number to identify you in the study. This research number (not 
your name) is what will be used to keep track of any personal information or data 
collected on you. All such data and information will be maintained in a password 
protected computer and/or locked file cabinet. A single document linking all 
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research numbers to specific patient names will be kept in a separate, secure 
location accessible only by the primary investigator of this study. Results of the 
research may be published for scientific purposes or presented to scientific groups, 
however, your identity will not be revealed. Per University of Pittsburgh policy, all 
research records must be maintained for at least 7 years following final reporting or 
publication of a project. Your de-identified research data may be shared with 
secondary investigators with similar research interests. 
 
Can I be removed from the research without my okay? 
 
The person in charge of the research study can remove you from the research 
study without your approval. Possible reasons for removal include failure to follow 
instructions of the research staff, breach of protocol, alteration of your clinical 
condition or required anesthetic plan including the need to convert to general 
anesthesia, or lack of sufficient staff availability. 
 
Are there costs of participating in this study? 
For this study, you will not be charged for any of the procedures performed for the 
purpose of this research 
 
Will I be paid to participate in this study? 
You will not be paid for your participation in this research study. 
 
What if I am injured while taking part in this study? 
If you believe that the research procedures have resulted in an injury to you, 
immediately contact the Principal Investigator who is listed on the first page of this 
form. Emergency medical treatment for injuries solely and directly related to your 
participation in this research study will be provided to you by the hospitals of UPMC. 
Your insurance provider may be billed for the costs of this emergency treatment, 
but none of those costs will be charged directly to you. If your research-related 
injury requires medical care beyond this emergency treatment, you will be 
responsible for the costs of this follow-up care. At this time, there is no plan for any 
additional financial compensation. You do not, however, waive any legal rights by 
signing this form 
 
Authorization to use and disclose individually identifiable health 
information for a research study 
Before you can take part in this research study, the University of Pittsburgh is 
required to obtain your authorization to use and/or disclose (release) your health 
information. This section describes how, and to whom, your health information will 
be used and/or disclosed (shared) while you are participating in this research study. 
 
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It is important that you read this carefully. The University of Pittsburgh and its 
researchers are required by law to protect your health information. This research 
study will involve the recording of past, current, and/or future identifiable 
(pertaining to only you) medical information from your hospital and/or other health 
care provider (e.g. physician office) records. This information will be used to 
determine your eligibility for this study and to follow your response once you are 
enrolled in the study. 
The following is a list of entities that may use and/or disclose your health 
information as part of this study: 
• 
Those who oversee the study will have access to your health information, 
including the following: 
o 
The University of Pittsburgh 
o 
The University of Pittsburgh Conduct and Compliance Office 
• Government agencies such as the Department of Health and Human Services 
who have oversight of the study or to whom access is required under the 
law. 
• Authorized representatives of the UPMC hospitals or other affiliated health 
care providers may have access to identifiable information (which may 
include your identifiable medical information) related to your participation in 
this research study for the purpose of (1) fulfilling orders, made by the 
investigators, for hospital and health care services (e.g., laboratory tests, 
diagnostic procedures) associated with research study participation; (2) 
addressing correct payment for tests and procedures ordered by the 
investigators; and/or (3) for internal hospital operations (i.e. quality 
assurance). 
• In unusual cases, the investigators may be required to release identifiable 
information (which may include your identifiable medical information) related 
to your participation in this research study in response to an order from a 
court of law. If the investigators learn that you or someone with whom you 
are involved is in serious danger or potential harm, they will need to inform, 
as required by Pennsylvania law, the appropriate agencies. 
• It is possible that collected data may also be shared with secondary 
investigators with similar research interests, but only in a de-identified 
fashion (your name and other identifying information will not be shared). 
In order to participate in this study, you must agree to share your health 
information with the persons and organizations listed above. If these persons or 
organizations that you authorize to receive and/or use protected health information, 
are not health plans, covered health care providers, or health care clearinghouses 
subject to federal health information privacy laws, they may further disclose the 
protected health information and it may no longer be protected by the federal 
health information privacy laws. 
A description of this clinical trial will be available on http://www.clinicaltrials.gov, as 
required by US Law. This website will not include information that can identify you. 
At most, the website will include a summary of the results. You can search this 
website at any time. 
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Expiration of Authorization 
This authorization will not expire unless you revoke it in writing. You may revoke or 
end this authorization by writing to the Principal Investigator: 
Nicholas J. Schott, M.D. 
Department of Anesthesiology 
Magee-Women’s Hospital 
300 Halket Street 
Pittsburgh, PA 15213 
If you revoke your authorization, you will also be removed from the study. 
Revoking your authorization only affects the use and sharing of your health 
information after the written request is received. Any health information obtained 
prior to receiving the written request may be used to maintain the integrity of the 
study. 
 
 
VOLUNTARY CONSENT: 
All of the above has been explained to me and all of my current questions have 
been answered. I understand that, throughout my participation in this research 
study, I am encouraged to ask questions about any aspect of this research study 
including the use and disclosure of my identifiable medical record information. 
Such future questions will be answered by the investigators listed on the first page 
of this form. 
 
Any questions I have about my rights as a research participant or the research use 
of my medical information will be answered by the Human Subject Protection 
Advocate of the IRB Office, University of Pittsburgh (1-866-212-2668). 
 
By signing this form, I agree to participate in this research study and for the use 
and disclosure of my medical record information for the purposes described above. 
A copy of this consent form will be given to me. 
 
 
Signature of subject 
Date/Time 
 
 
Printed name of subject 
 
 
 
 
 
 
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CERTIFICATION OF INFORMED CONSENT: 
I certify that I have explained the nature and purpose of this research study to the 
above-named individual(s), and I have discussed the potential benefits and possible 
risks of study participation. Any questions the individual(s) have about this study 
have been answered, and we will always be available to address future questions, 
concerns or complaints as they arise. I further certify that no research component 
of this protocol was begun until after this consent form was signed. 
 
 
 
Investigator signature 
Date/Time 
 
 
 
Printed name of investigator 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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SAP_004.pdf: 
 
 
 
 
 
 
 
STUDY TITLE: Quadratus Lumborum Block versus Intrathecal Morphine for Postoperative Pain Control 
after Cesarean Delivery 
 
Principal Investigator: Nicholas J. Schott, MD 
Source of Support: UPMC Department of Anesthesiology and Perioperative Medicine 
NCT: 03261193 
Date of Approval: 08/14/2017 
 
 
 


STATISTICAL ANALYSIS PLAN 
 
The primary outcome is the mean numeric rating scale (CRS) pain scores with activity 24-hours 
after completion of the quadratus lumborum block. Previous work comparing dynamic pain outcomes 
among women undergoing cesarean delivery with and without quadratus lumborum block 1 reported 
median (IQR) pain scores at 24-hours of 2 (0-3) in the intervention group and 4 (2-5) in the control 
group. Mean and standard deviation were estimated from this data using mean=median and SD = 
IQR/1.35.2. For 2 groups, a total sample of 60 subjects (~26 in each group completed) is estimated to 
achieve 80% power to detect differences among the NRS means versus the alternative of equal means 
using an F-test with a 0.05 significance level. The size of variation in the means represented by the 
standard deviation is assumed to be 1.00, with a common standard deviation within a group of 2.22. To 
account for subject dropout and/or ineligibility, 60 subjects will be screened for randomization into 2 
groups, with 30 subjects to be screened for each group. 
References: 
1. Blanco R., Ansari T., Girgis E. Quadratus lumborum block for postoperative pain after cesarean 
section: A randomized controlled trial. Eur J Anaesthesiol. 2015 Nov; 32(11): 812-8. 
2. Hozo SP., Djulbegovic B., Hozo I. Estimating the mean and variance from the median, range, and 
the size of a sample. BMC Med Res Methodol. 2005 Apr 20; 5:13. 

Prot_003.pdf: 
 
 
 
 
 
 
 
 
STUDY TITLE: Quadratus Lumborum Block versus Intrathecal Morphine for Postoperative Pain 
Control after Cesarean Delivery 
 
Principal Investigator: Nicholas J. Schott, MD 
Source of Support: UPMC Department of Anesthesiology and Perioperative Medicine 
NCT: 03261193 
Date of Approval: 08/14/2017 
 


8/14/2017 
PRO16120234 - QL block for post-cesarean delivery pain 
https://www.osiris.pitt.edu/osiris/CustomLayouts/SmartFormPrint/PrintSmartForms?Project=com.webridge.entity.Entity%5BOID%5BFCOB57F8C31E8.. 
1/42 
 
 
 
 
 
 
 
[reviewer notes,] 
 
 
 
 
Provide a short title for this study (200 characters or less): 
QL block for post-cesarean delivery pain 
!section: Triage! 
 
Tl.O 
 
Select the type of application: 
New Research Study 
 
T2.0 
 
Is the proposed research study limited to the inclusion of deceased individuals? 
* No 
 
T2.1 
 
Are any research activities being conducted at the VA Pittsburgh Healthcare 
System or with VA funds? 
* No 
 
 
 
 
[reviewer notes,] 
 
T3.0 
What is the anticipated risk to the research participants? 
 
Greater Than Minimal Risk 


8/14/2017 
PRO16120234 - QL block for post-cesarean delivery pain 
https://www.osiris.pitt.edu/osiris/CustomLayouts/SmartFormPrint/PrintSmartForms?Project=com.webridge.entity.Entity%5BOID%5BFCOB57F8C31E8.. 
2/42 
 
 
 
 
[reviewer notes-,] 
 
 
CS1.0 
What is the reason for this submission? 
New Research Protocol Submission 
!section: Cover Sheetl 
CS1.1  
Has this research study been approved previously by the University of Pittsburgh 
IRB? 
* No 
 
CSl.1.1  
Has this research study ( or a substantially similar research study) been previously 
disapproved by the University of Pittsburgh IRB or, to your knowledge, by any other 
IRB? 
* No 
 
 
 
 
[reviewer notes-,] 
 
 
CS2.0 
 
Title of Research Study: 
Quadratus Lumborum Block for Postoperative Pain Control after Cesarean Delivery 
 
CS2.0.1 
Requested approval letter wording: 
 
CS2.1 
Research Protocol Abstract: 
 
Effective post-cesarean delivery analgesia is important to achieving functional recovery 
after cesarean delivery, and it is an influential factor shaping the patient experience. 
Currently, neuraxial morphine (e.g., Intrathecal Morphine, ITM) is an integral component of 
multimodal post-cesarean delivery analgesia. It is considered a standard of care in the 
administration of neuraxial anesthesia for cesarean delivery. ITM is also associated with side 
effects, including nausea, vomiting, respiratory depression, urinary retention and pruritus, 
although these side effects are dose-dependent and weighed by patients to be less 
important than pain after cesarean delivery. 
 
Supplemental peripheral nerve blocks have been studied extensively for post-cesarean 
delivery pain and have focused primarily on local infiltration with or without catheters, 
transversus abdominis plane (TAP) blocks, and ilioinguinal iliohypogastric (IIIH) blocks. 
These blocks and have not shown superiority to ITM for dynamic pain outcomes, but may 
have a role in supplemental or "rescue" analgesia whenever ITM cannot be given (e.g., 
general anesthesia for cesarean delivery; contraindication to ITM). The ultrasound-guided 
quadratus lumborum block (QLB) is a regional anesthetic technique that has shown some 
promise in improving pain following cesarean delivery compared to placebo, though no 
randomized studies have directly compared it to the current gold standard, multimodal 
analgesia with ITM. Furthermore, QLB may have advantages over the TAP block in terms of 
its more superficial location (easier ultrasound visualization thereby theoretically conferring 
improved safety). In this context, the utility of QLB as part of a multimodal analgesic 
approach that includes ITM for post-cesarean delivery pain warrants investigation. 
 
Objectives: 
The objective of this study is to determine if the QLB adds benefit to a multimodal analgesia 
regimen that includes ITM for patients after scheduled elective cesarean delivery. 
 
Study Design: 


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Note: Adjunct faculty of the University, including lecturers and instructors, are not 
permitted to serve as a PI or Faculty Mentor but may serve as co-investigators. Refer to 
Chapter 4 on the HRPO website for more information. 
 
 
Prospective, single center, randomized control trial 
!section: Cover Sheetl 
 
Setting/Participants: 
This study will be limited to patients presenting to Magee Women's Hospital (MWH) for 
scheduled, elective cesarean delivery under spinal anesthesia. We plan to enroll a total of 
60 patients for this study. Inclusion criteria include elective cesarean delivery under spinal 
anesthesia, singleton pregnancy, American Society of Anesthesiologists (ASA) classification 
score of 2 or less, and term gestational age of at least 37 weeks. Exclusion criteria include: 
contraindications to neuraxial blockade; anatomical abnormalities affecting spinal or QLB 
placement (i.e. scoliosis, conversion to general anesthesia); contraindications or true 
allergies to morphine, NSAIDs, acetaminophen, other oral opioids, or local anesthetics; 
presence of chronic pain history or opioid dependence on or off maintenance therapy. 
 
Study Interventions and Measures: 
Subjects will be randomized to one of two groups: ITM plus sham (saline) QLB and ITM plus 
true (bupivacaine) QLB. The primary outcome is pain on movement at 24 hours post­ 
cesarean delivery. Other outcome measures that will be assessed and evaluated include: 
• VAS pain scores at rest and with movement (VAS pain score with movement at 24 hrs will 
be the primary outcome) 
• Time to first request for PRN oral or parenteral opioid 
• Total opioid pain medications required throughout hospital stay 
• Presence/absence of sedation, itching, and nausea/vomiting 
• Vital signs - heart rate (HR), blood pressure (BP), respiratory rate (RR), and oxygen 
saturation (SpO2) 
• Signs of local anesthetic toxicity including perioral numbness, ringing in the ears, or 
metallic taste in the mouth within 4 hours of block (assessed at 15 min, 30 min, 45 min, 1 
hour and 4 hours by nursing or study personnel) 
• Breastfeeding success and quality 
 
The primary outcome will be measured at baseline (entry to post-anesthesia care unit) and 
at 1 hr, 4 hrs, 24 hrs, and 48 hrs following the completion of the QLB (true or sham) 
CS2.2 
 
Select the category that best describes your research: 
Biomedical research 
 
[reviewer notes,] 
 
CS3.0 
 
 
 
 
 
 
 
 
 
 
CS3.1 
Name of the Principal Investigator: 
 
Nicholas Schott 
 
Affiliation of Principal Investigator: 
 
UPP or UPMC staff member 
 
 
If you chose any of the Pitt options, please indicate the specific campus: 
 
If you chose the UPitt faculty member option, provide the Pl's University Faculty Title: 
 
 
CS3.2 
 
Address of Principal Investigator: 
 
Department of Anesthesiology 


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Magee-Womens Hospital 
300 Ha ket Street 
Pittsburgh, PA 15213 
!section: Cover Sheetl 
 
CS3.3 
 
 
 
 
CS3.4 
 
 
 
 
 
CS3.S 
 
 
CS3.6 
 
 
 
 
 
CS3.7 
 
 
CS3.8 
 
 
 
 
 
 
CS3.9 
Recorded Primary Affiliation of the Principal Investigator: 
 
UPMC I Other 
 
Identify the School, Department, Division or Center which is responsible for 
oversight of this research study: 
 
 
 
Telephone Number of Principal Investigator: 
412-641-4260 
 
Recorded Current E-mail Address of Principal Investigator to which all 
notifications will be sent: 
 
schottnj@u pmc.edu 
 
Fax Number: 
412-641-4766 
Does this study include any personnel from Carnegie Mellon University, and/or 
use any CMU resources or facilities (e.g., Scientific Imaging and Brain Research 
Center (SIBR)? 
 
* No 
 
Is this your first submission, as PI, to the Pitt IRB? 
* No 
 
 
 
[reviewer notes-,] 
 
CS4.0 
 
List of Co-Investigators: 
 
 
Last 
First 
Organization 
Dalby Patricia 
U of Pgh I School of Medicine I Anesthesiology 
Lim  Katherine Grace U of Pgh I School of Medicine I Anesthesiology 
Schott Nicholas 
UPMC I Other 
Vernon Thomas 
Waters Jonathan 
Other I Other 
U of Pgh I School of Medicine I Anesthesiology 


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[reviewer notes-,] 
!section: Cover Sheetl 
 
 
css.o 
 
 
 
 
CSS.1 
 
 
 
 
 
 
 
CSS.2 
 
 
 
 
CS6.0 
 
 
CS6.1 
CS6.2 
CS6.3 
Name of Primary Research Coordinator: 
 
Nicholas Schott 
 
 
 
 
Address of Primary Research Coordinator: 
Department of Anesthesiology 
Magee-Womens Hospital 
300 Halket Street 
Pittsburgh, PA 15213 
 
 
Telephone Number of Primary Research Coordinator: 
412-641-4260 
 
 
Name of Secondary Research Coordinator: 
 
Address of Secondary Research Coordinator: 
 
Telephone Number of Secondary Research Coordinator: 
 
Key Personnel/Support Staff (Only list those individuals who require access to 
OSIRIS): 
Last First Organization 
There are no items to display 
[reviewer notes-,] 
 
CS7.0 
 Will this research study use any Pediatric PittNet or Clinical and Translational 
Research Center (CTRC) resources? 
No 
 
 
 
[reviewer notes,] 
 
css.o 
Select the entity responsible for scientific review. 
 
Department Review - (a dean, department chair, division chief, or center head) 
Note: DoD funded studies require departmental review 
 
 
CSS.1 
 
Select the school, department or division which is responsible for scientific review 
of this submission. 
 
 
 
 
 


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[reviewer notes-,] 
!section: Cover Sheetl 
 
 
CS9.0 
 
 
 
 
CS9.1 
 
 
 
 
 
 
CS10.0 
Does this research study involve the administration of an investigational drug or 
an FDA-approved drug that will be used for research purposes? 
* Yes 
 
 
Do you plan to utilize the Investigational Drug Service (IDS) to dispense the 
drug? 
* No 
 
 
 
Is this research study being conducted under a University of Pittsburgh-based, 
sponsor-investigator IND or IDE application? 
 
* No 
If YES, you are required to submit the IND or IDE application and all subsequent FDA 
correspondence through the Office for Investigator-Sponsored IND and IDE Support 
(0315). Refer to applicable University policies posted on the 0315 website 
(www.0315.pitt.edu). 
 
 
 
[reviewer notes-,] 
 
CS11.0  
Use the 'Add' button to upload one or more of the following: 
• the sponsor protocol (including investigator initiated studies) and/or 
other brochures 
• the multi-center protocol and consent form template, if applicable 
Name Modified Date 
 
Is this research study supported in whole or in part by industry? This includes the 
provision of products (drugs or devices). 
 
* No 
Is this a multi-centered study? 
* No 


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If you selected School, International or Other, list the sites: 
 
 
[reviewer notes-,] 
!section: Cover Sheetl 
 
 
CS12.0  
Does your research protocol involve the evaluation or use of procedures that emit 
ionizing radiation? 
* No 
 
CS13.0 
 
 
 
 
 
 
 
 
CS14.0 
Does this research study involve the deliberate transfer of recombinant or 
synthetic nucleic acid molecules into human subjects? 
* No 
Upload Appendix M of NIH Guidelines: 
Name 
Modified Date 
 
 
 
Are you using UPMC facilities and/or UPMC patients during the conduct of your 
research study? 
* Yes 
If Yes, upload completed Research Fiscal Review Form: 
 
 
Magee Fiscal Form- No costs to be occured 
6/25/2017 5:30 PM 
 
 
 
[reviewer notes-,] 
 
CS15.0  
Indicate the sites where research activities will be performed 
and/or private information will be obtained. 
 
Choose all sites that apply and/or use Other to include sites not listed: 
Sites: 
UPMC 
 
 
 
 
 
 
 
 
*For research being conducted at non Pitt or UPMC sites, upload a 
site permission letter granting the researcher permission to 
conduct their research at each external site: 
Name Modified Date 
Name 
 
 
 
UPMC Magee Women's Hospital 


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ICS15.1 
Have you, Nicholas Schott, verified that all members of the 
!section: Cover Sheetl 
research team have the appropriate expertise, credentials, and if 
applicable, hospital privileges to perform those research 
procedures that are their responsibility as outlined in the IRB 
protocol? 
* Yes 
 
CS15.2  
Describe the availability of resources and the adequacy of the 
facilities to conduct this study: 
* Magee Women's Hospital (MWH) sees nearly 9,000-10,000 patient 
encounters for deliveries a year. There are on average 3-4 elective C­ 
sections taking place at MWH every weekday which would provide an 
ample and diverse sampling of patients to enroll for this study. MWH has 
all of the staff and resources necessary to provide complete care for 
laboring and delivering patients. An ultrasound machine as well as the 
other appropriate drugs and supplies area available at MWH to perform 
the quadratus lumborum block (QLB), and all blocks will be performed by 
people adequately trained in the procedure. The PI does have sufficient 
time to participate in and oversee the study, and does have access to 
UPMC password protected computers and servers by virtue of job 
responsibilities. Storage and distribution of data can be easily managed 
with any paper information being stored in locked file cabinets inside 
locked personal offices belonging to the PI or other listed co-investigators, 
and any electronic information being stored only on UPMC password 
protected computers. All disclosure of private information from patients 
will take place in a private pre-operative holding room, inside the 
operating room, or in the patient's private hospital room at MWH as is 
already the practice for obtaining such information for all elective 
procedures that are performed there everyday. MWH is fully equipped 
with both the staff and equipment necessary to handle any routine 
management or emergency situation that may arise related to this study. 
 
 
 
 
[reviewer notes,] 
 
CS16.0 
Special Research Subject Populations: 
Categories 
Pregnant women, fetuses and/or neonates 
[reviewer notes,] 
 
CS17.0 
Does your research involve the experimental use of any type of human stem cell? 
 
* No 


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[reviewer notes-,] 
!section: Cover Sheetl 
 
 
 
 
 
NIH Definition of a Clinical Trial 
 
A research study1 in which one or more human subjects2 are prospectively 
assigned3 to one or more interventions4 (which may include placebo or other 
control) to evaluate the effects of those interventions on health related biomedical 
or behavioral outcomes.5 
1 See Common Rule definition of research at 45 CFR 46.102(d). 
2 See Common Rule definition of human subject at 45 CFR 46.102(f) . 
3 The term "prospectively assigned" refers to a pre-defined process ( e.g., 
randomization) specified in an approved protocol that stipulates the assignment of 
research subjects (individually or in clusters) to one or more arms (e.g., intervention, 
placebo, or other control) of a clinical trial. 
4 An intervention is defined as a manipulation of the subject or subject's environment 
for the purpose of modifying one or more health-related biomedical or behavioral 
processes and/or endpoints. Examples include: drugs/small molecules/compounds; 
biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., 
telemedicine, face-to-face interviews); strategies to change health-related behavior 
(e.g., diet, cognitive therapy, exercise, development of new habits); treatment 
strategies; prevention strategies; and, diagnostic strategies. 
5 Health-related biomedical or behavioral outcome is defined as the pre-specified 
goal(s) or condition(s) that reflect the effect of one or more interventions on human 
subjects' biomedical or behavioral status or quality of life. Examples include: 
positive or negative changes to physiological or biological parameters (e.g., 
improvement of lung capacity, gene expression); positive or negative changes to 
psychological or neurodevelopmental parameters (e.g., mood management 
intervention for smokers; reading comprehension and /or information retention); 
positive or negative changes to disease processes; positive or negative changes to 
health-related behaviors; and, positive or negative changes to quality of life. 
 
CS18.0 
 * Based on the above information, does this study meet the NIH definition of a 
clinical trial? 
Yes 
 No 
 
 
If Yes, click Save and then Click Here For Study Team's CITI Training Records . Please 
ensure all personnel's training is up to date 
 


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[reviewer notes-,] 
!section: Section 1 - Objective, Aims, Background and Significance! 
 
 
1.1 
Objective: What is the overall purpose of this research study? (Limit response to 1- 
2 sentences.) 
The purpose of this trial is to determine the effectiveness of a postoperative analgesia 
strategy that includes QLB added to a multi-modal post-cesarean analgesia strategy. We 
hypothesize that the QLB provides superior post-cesarean analgesia compared to the 
current standard of care, multi-modal analgesia. 
 
1.2 
 Specific Aims: List the goals of the proposed study ( e.g., describe the relevant 
hypotheses or the specific problems or issues that will be addressed by the 
study). 
We will determine if the quadratus lumborum block (QLB) provides superior analgesia to 
patients following cesarean delivery compared to the current standard of care, multi-modal 
analgesia (i.e., ITM and scheduled post-operative non-opioid oral analgesics, with ora 
opioid analgesics reserved for breakthrough pain). 
We will measure side-effects associated with each strategy: standard of care (ITM + care 
described above, plus sham QLB with saline), and standard of care plus true QLB. 
 
We will measure and model economic ramifications associated with each strategy, modeling 
factors including drug costs, procedure costs, costs associated with length of stay and re­ 
admissions. 
 
1.3 
Background: Briefly describe previous findings or observations that provide the 
background leading to this proposal. 
The quadratus lumborum block (QLB) is similar to the transversus abdominis plane (TAP) 
block, but differs slightly in regards to the location where local anesthetic is injected. 
Because of the more posterior location of the QLB, it theoretically confers greater safety 
due to enhanced visualization (1). The TAP block has been studied extensively for post­ 
cesarean delivery pain, consistently showing that it is not superior to ITM for post-operative 
analgesia, but that it may have a role in patients with breakthrough pain despite the use of 
ITM, or in patients who were unable to receive it (e.g. general anesthesia for cesarean, 
contraindications to neuraxial morphine). ITM is superior to TAP alone for post-cesarean 
analgesia, but it is associated with a dose-dependent increased risk for opioid related side 
effects (2,4,5). In 2015, Blanco et. al. published a study specifically using the QLB for 
postoperative pain after cesarean delivery (1). In this study, they compared a true QLB to a 
sham QLB all in patients who did not receive ITM, and found that the QLB provided 
improved pain control and decreased the need for post-operative opioids. Another study in 
2016 demonstrated that the QLB is superior to the TAP block in regards to decreasing post­ 
operative pain following c-section (3). Unfortunately, neither study compared the QLB to 
ITM (part of the current gold standard for post-cesarean delivery pain, multimodal 
analgesia). 
 
References 
(see supporting documentation) 
 
1.4 
Significance: Why is it important that this research be conducted? What gaps in 
existing information or knowledge is this research intended to fill? 
This research is important to conduct because clinicans must constantly evaluate the 
medical management of patients to find ways that provide the most benefit with the least 
risk of harm. Post-operative pain control following cesarean delivery is an area that is 
important to patients and to providers, and the introduction of the QLB for this purpose has 
the potential to improve analgesic benefits. 


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[reviewer notes-,] 
!section: Section 2 - Research Design and Methods! 
 
 
 
2.1 
Does this research study involve the use or evaluation of a drug, biological, or 
nutritional (e.g., herbal or dietary) supplement? 
* Yes 
2.1.1 
 
Does this research study involve an evaluation of the safety and/or effectiveness 
of one or more marketed nutritional (e.g., herbal or dietary) supplements for the 
diagnosis, prevention, mitigation or treatment of a specific disease or condition or 
symptoms characteristic of a specfic disease or condition? 
* No 
 
 
 
 
[reviewer notes-,] 
 
2.1.2 
 
Does this research study involve the use or evaluation of one or more drugs or 
biologicals not currently approved by the FDA for general marketing? 
* No 


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[reviewer notes-,] 
!section: Section 2 - Research Design and Methods! 
 
 
2.1.3 
 Does this research involve the use or an evaluation of the effectiveness and/or 
safety of one or more drugs or biologicals currently approved by the FDA for 
general marketing? 
* Yes 
 
2.1.3.1  
Are the FDA-approved drugs or biologicals being evaluated in this research study 
for a new clinical indication, different population, or route of administration 
and/or dosage level that is not currently specified in the FDA-approved product 
labeling? 
 
Drugs are often used Off-Label during routine practice. Before answering this question, 
review the FDA product labeling (http://labels.fda.gov) for the approved "Indications and 
Usage." If being used off-label, answer Yes to this question. You are required to provide 
information and/or upload the package insert for each drug that is administered for 
research purposes. 
* No 
If you respond YES, an IND number or the FDA written concurrence of IND exemption may 
be required. 
 
 
 
Upload information on FDA approved indications/doses and FDA exemption letter 
if applicable: 
Name 
Modified Date 
 
 
 
 
 
[reviewer notes,] 
 
2.2 
 Will this research use or evaluate the safety and/or effectiveness of one or 
more devices? 
* No 
 
 
 
 
[reviewer notes-,] 
 
2.3 
Summarize the general classification (e.g., descriptive, experimental) and 
methodological design (e.g., observational, cross-sectional, longitudinal, 
randomized, open-label single-blind, double-blind, placebo-controlled, active 
treatment controlled, parallel arm, cross-over arm) of the proposed research 
study, as applicable. 
Prospective, single center, randomized controlled trial 
2.3.1 
 
Does this research study involve a placebo-controlled arm? 
* Yes 


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[reviewer notes-,] 
!section: Section 2 - Research Design and Methods! 
 
 
2.3.1.1 
Is there a commonly used diagnostic/treatment approach that is currently 
recognized as being effective for the proposed subjects' disease or condition, and 
that will be withheld from subjects assigned to the placebo arm of this research 
study? 
No; subjects assigned to the placebo and experimental arms of the research study will 
continue to undergo a commonly used diagnostic/treatment approach 
[reviewer notes-,] 
 
2.4 
 Will any research subjects be withdrawn from known effective therapy for the 
purpose of participating in this research study? 
* No 
 
 
 
 
[reviewer notes.] 
 
2.5 
 Will screening procedures (i.e., procedures to determine research subject 
eligibility) be performed specifically for the purpose of this research study? 
* Yes 
2.5.1 
 
List the screening procedures that will be performed for the purpose of this 
research study. Do NOT include the inclusion/exclusion criteria in this section as 
they will be addressed in section 3; questions 3.13 and 3.14. 
 
Potential patients will be assessed from the obstetrical operating room schedule the day 
prior. All scheduled cesarean deliveries will be screen for meeting inclusion criteria. Patients 
who are screened for inclusion will have discussion of informed consent to be involved in 
study. 
 
 
 
[reviewer notes.] 
 
 
 
 
2.6  
 
Provide a detailed description of all research activities (e.g., all drugs or devices; 
psychosocial interventions or measures) that will be performed for the purpose of 
this research study. 
 
This description of activities should be complete and of sufficient detail to permit 
an assessment of associated risks. 
At a minimum the description should include: 
• all research activities 
• personnel (by role) performing the procedures 
• location of procedures 
• duration of procedures 
• timeline of study procedures 
A waiting period of 5-30 minutes will elapse between introduction of the study to the 
participant, and enrolling the participant into the study. At the time the participant has been 
enrolled into the study and the cesarean delivery is confirmed to occur, the pharmacist will 
be instructed to open an opaque, sealed, numeric envelope labeled only with a study 


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number. The envelope will contain the randoml e 
s !a+ ea> itD and Methods! 
Participants wi  be assigned to either contra (ITM pus sham QLB with sa ine) or 
experimental (ITM plus QLB bupivacaine). The pharmacist will then dispense the blinded 
study drug to the investigator. Group assignment will not be revealed to the investigator, 
anesthesiology team, nursing team, obstetricians, nor participants, to achieve a double 
blind. 
 
Spinal anesthesia will occur per institutional routine: either L3-4 or L4-5 consisting of 1.6 cc 
(12 mg) of 0.75% hyperbaric bupivacaine plus fentanyl 15 mcg and morphine 150 mcg in 
accordance with current institutional standards. Spinal anesthetics will be performed in the 
operating room (OR) by senior residents (CA2 or 3), fellows, or attendings only. 
 
Following the cesarean delivery, bilateral QLB will be performed using the study drug (either 
saline or true drug). QLB will be performed under ultrasound guidance either in the 
operating room immediately after surgical drapes are lowered and prior to transfer to PACU, 
or immediately upon arrival to the PACU. Each unilateral QLB will consist of 40 cc of 0.25% 
bupivacaine (20 ml deposited per side). Prior to the QLB procedure, the patient will be 
prepped and draped in a sterile fashion. Sterile gloves, a hat, and a mask will be worn and 
sterility maintained throughout the procedure. Each unilateral QLB typically takes about 2- 
10 minutes to complete. The drugs used are FDA approved for the indication used in this 
research. 
 
Post-operative analgesia protocol: patients in all groups will be given 30 mg IV ketorolac 
scheduled q6hrs x 3 doses (unless contraindications). Alter ketorolac, they will receive 600 
mg PO ibuprofen q6hrs scheduled for mild pain (1-3) x 24 hours, as well as Tylenol 500 mg 
PO q4hrs scheduled for mild pain (1-3) x 24 hours (total acetaminophen dose not to exceed 
3000 mg in 24 hours). For breakthrough pain, patients will have PRN oxycodone 5-10 mg 
PO q4hrs for moderate (4-6) or severe (7-10) breakthrough pain. If needed, some patients 
may also receive PRN IV morphine or other parenteral opioid if breakthrough pain is severe 
despite PRN oral oxycodone or if they are unable to take PO medications. All of these 
medications and doses are typical, standard post-operative orders commonly used for pain 
control in patients who have undergone a cesarean delivery. 
 
The outcome measures that will be assessed and evaluated in all three groups include: 
• VAS pain scores at rest and with movement (VAS pain score with movement at 24 hours 
will be the primary outcome) 
• Time to first request for PRN oral or parenteral opioid 
• Total opioid analgesics required throughout hospital stay 
• Presence/absence of sedation, itching, and nausea/vomiting 
• Vital signs - respiratory rate (RR), and oxygen saturation (SpO2) 
• Signs of local anesthetic toxicity (e.g., perioral numbness, ringing in the ears, or metallic 
taste in the mouth, other non-specific neurological symptoms) within 4 hours of block 
(assessed at 1 5min, 30 min, 45 min, 1 hour and 4 hours by nursing or study personnel) 
• Breastfeeding success and quality 
 
The primary outcome will be measured at baseline (entry to post-anesthesia care unit, and 
immediately after QLB) and at 1 hour, 4 hours, 24 hours, and 48 hours following completion 
of the QLB. Follow-up will occur in the recovery room and in patient's rooms. 
 
Post-operative scores for pruritus will be rated on a numeric 0-3 scale (0, none; 1, mild; 2, 
moderate; 3, severe), and nausea will be rated on a numeric 0-3 scale (0, none; 1, mild; 2, 
moderate; 3, severe or vomiting). Perioral numbness, ringing in ears, or metallic taste in 
mouth will be rates as either present or absent. 
 
Following the final evaluation at 48 hours, participation in the study will be considered 
complete. 
 
2.6.1 
 
Will blood samples be obtained as part of this research study? 
* No 
*If submitting a protocol for expedited review, it should be clear that the planned blood 
draws are within the parameters described here: 
http://www.hhs.gov/ohrp/policy/expedited98.html (see Expedited Research Category #2) 


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If Yes, address the frequency, volume per wit 8llt-1olii:t ctflN:i 2oll.ffi! 'i!l:IY si9 Ce Methodsl 
 
 
 
 
 
 
 
 
Study Flow Chart: 
 
Name 
QLB Study Flowchart 
Modified Date 
6/23/2017 7:32 PM 
 
[reviewer notes-,] 
 
2.7 
 Will follow-up procedures be performed specifically for research purposes? 
Follow-up procedures may include phone calls, interviews, biomedical tests or 
other monitoring procedures. 
* Yes 
See study flow chart in question 2.6 
 
 
 
 
[reviewer notes-,] 
 
2.8 
Does this research study involve the use of any questionnaires, interview or 
survey instruments? 
* Yes 
 
 
Upload a copy of all materials except for the SCIO or KSADS which are on file at 
the IRB. The use of all instruments must be addressed in question 2.6 and/or 
question 2.7 (except for an exempt submission where they should be addressed 
on the appropriate uploaded exempt form). 
 
Name 
Data Collection Form 
Modified Date 
5/21/2017 5:37 PM 
Previously the name and publisher for commercially available materials 
were listed in the textbox below but effective 9/1/2015, all materials (except for 
the SCID and KSADS) must be uploaded using the Add button above. 
 


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[reviewer notes-,] 
!section: Section 2 - Research Design and Methods! 
 
 
2.9  
 
If subjects are also patients, will any clinical procedures that are being used for 
their conventional medical care also be used for research purposes? 
* yes 
 
If Yes, describe the clinical procedures (and, if applicable, their frequency) that will be 
used for research purposes: 
Performing a spinal anesthetic consisting of intrathecal morphine is part of the routine, 
conventional medical care for patients undergoing an elective cesarean delivery. In this 
study, the benefits of the pain control and any associated side effects from spina 
anesthesia with intrathecal morphine will be evaluated. 
2.10 
The blood sample question was moved to 2.6.1. 
[reviewer notes-,] 
 
2.11 
 What is the total duration of the subject's participation in this research study 
across all visits, including follow-up surveillance? 
* 48 hours 
[reviewer notes-,] 
 
 
 
 
 
2.12 
Does this research study involve any type of planned deception? 
If Yes, you are required to request an alteration of the informed consent process (question 
4.7) 
* No 
 
 
 
[reviewer notes-,] 
 
 
 
 
2.13 
Does this research study involve the use of UPMC/Pitt protected health 
information that will be de-identified by an IRB approved "honest broker" 
system? 
* No 
 
 
 
[reviewer notes-,] 
 
 
 
 
2.14  
 
Will protected health information from a UPMC/Pitt HIPAA covered entity be 
accessed for research purposes or will research data be placed in the UPMC/Pitt 
medical record? 
* Yes 
 
 
If  you answer Yes, you are required to submit this study to the Center for Assistance in 


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Research using e-Record (CARe). Per UPMC P t!rlfuR 
clll-rR ermlliJOO 
Methods! 
access or invo ve UPMC e ectronic protected heath information (e-PHI) must be submitted 
to CARe, with the exception of clinical trials that are contracted through the UPMC Office of 
Sponsored Programs and Research Support (OSPARS). 
Complete the online submission form at https://care.upmc.com/request.aspx. After the 
study is submitted in OSIRIS, a CARe representative will conduct a review. You will be 
notified once your CARe review is complete or if anything further is needed. 
 
Studies that will access only paper-based medical records (not in combination with any 
electronic records) do not need to be submitted to CARe. 
 
For additional information, please see https://care.upmc.com. 
 
 
Describe the medical record information that will be collected from the UPMC/Pitt 
HIPAA covered entity and/or the research-derived information that will be placed 
in the medical records. 
 
As part of this study, it will be necessary to review the patient's medical history to ensure 
that they have no contraindications to neuraxial anesthesia or a quadratus lumborum block. 
This typically involves briefly looking through the patients medical record to check their 
medical history and lab values, and a face to face discussion with the patient prior to their 
cesarean delivery. All patients presenting for an elective cesarean delivery are also routinely 
given a paper form that reviews their medical history. All of this information will be 
reviewed both for their routine care and also for the purposes of this study. No additional 
information other than what is reviewed for routine care for an elective cesarean will need 
to be obtained as a result of this study. For participants receiving QLB, data summarizing 
the procedure including exactly what medication and dose was given will be placed in the 
UPMC/Pitt medical record ("Study Drug" for the local anesthetic will be noted, to maintain 
blinding). Following the cesarean delivery, some follow-up measures (e.g. oral and 
parenteral pain medications) may be gleaned and recorded as it is routinely documented in 
the medical record. 
2.14.1 
 Will protected health information from a non-UPMC/Pitt HIPAA covered entity be 
obtained for research purposes or will research data be placed in the non­ 
UPMC/Pitt medical record? 
* No 
 
I, Nicholas  Schott, certify that any member of my research team accessing, 
reviewing and/or recording information from medical records have completed 
HIPAA Researchers Privacy Requirements (Formerly RPF Module 6) training. The 
HIPAA certificates must be available for review if audited but do not need to be 
uploaded into this OSIRIS application. 
* Yes 
 
2.14.2  
 
Are you requesting a waiver of the requirement to obtain written HIPAA 
authorization for the collection of the PHI? 
* No 


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[reviewer notes-,] 
!section: Section 2 - Research Design and Methods! 
 
 
2.15 
Does this research study involve the long-term storage (banking) of biological 
specimens? 
 
* No 
 
 
 
[reviewer notes-,] 
 
2.16 
 Will research participants be asked to provide information about their family 
members or acquaintances? 
* No 
 
 
 
[reviewer notes-,] 
 
2.17 
What are the main outcome variables that will be evaluated in this study? 
The outcome measures that will be assessed and evaluated in all three groups include: 
• VAS pain scores at rest and with movement (VAS pain score with movement at 24 hours 
will be the primary outcome) 
• Time to first request for PRN oral or parenteral opioid 
• Total opioid analgesics required throughout hospital stay 
• Presence/absence of sedation, itching, and nausea/vomiting 
• Vital signs - respiratory rate (RR), and oxygen saturation (SpO2) 
• Signs of local anesthetic toxicity (e.g., perioral numbness, ringing in the ears, or metallic 
taste in the mouth, other non-specific neurological symptoms) within 4 hours of block 
(assessed at 1 5min, 30 min, 45 min, 1 hour and 4 hours by nursing or study personnel) 
• Breastfeeding success and quality 
 
The primary outcome will be measured at baseline (entry to post-anesthesia care unit, and 
immediately after QLB) and at 1 hour, 4 hours, 24 hours, and 48 hours following completion 
of the QLB. Follow-up will occur in the recovery room and in patient's rooms. 
 
2.18 
Describe the statistical approaches that will be used to analyze the study data. 
* Addressed below: 
The primary outcome is the mean numeric rating scale (NRS) pain scores with activity at 24 
hours after completion of the quadratus lumborum block. The primary outcome will be 
compared between groups using the two-tailed unpaired Student t-test. Interval and ordinal 
data will be compared between groups using the two-tailed Student's t-test or the Mann­ 
Whitney U-test after testing for normal distribution. Categorical data will be compared using 
a Chi-Square statistic or the Fisher's exact test. 
 
We will apply Bonferroni correction for multiple comparisons. The time-to-first-supplemental 
opioid analgesic request will be compared by Cox proportional hazard modeling. Subjects 
who do not request additional analgesia will be censored at the time of delivery. P < 0.05 
will be used to reject the null hypothesis. 


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[reviewer notes-,] 
!section: Section 2 - Research Design and Methods! 
 
 
2.19  
 
Will this research be conducted in (a) a foreign country and/or (b) at a site (e.g., 
Navajo Nation) where the cultural background of the subject population differs 
substantially from that of Pittsburgh and its surrounding communities? 
* No 
 
Note that copies of training records, licenses, certificates should be maintained in the 
study regulatory binder and are subject to audit by the Research Conduct and Compliance 
Office (RCCO). 
 
In addition, individuals planning to conduct human subject research outside the United 
States must complete an optional module on the CITI training website: International 
Studies. Click here to access the instruction sheet for accessing optional CITI modules. 
 
 
 
 
 
 
 
[reviewer notes-,] 
 
 
2.21 
 
Will this research study be conducted within a nursing home located in 
Pennsylvania? 
* No 


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!section: Section 3 - Human Subjects! 
 
[reviewer notes-,] 
Section 3 - Human Subjects 
3.1 
What is the age range of the subject population? 
 
Women of childbearing age >/= 18 years of age will be enrolled 
3.2 
What is their gender? 
* Females only - Provide a justification for limiting enrollment to only one gender. 
Provide a justification if single gender selected: 
Because we are looking at post-operative pain control after cesarean , this study must be 
limited to women as only women can become pregnant and thus have the need to undergo 
a cesarean for delivery. 
3.3 
Will any racial or ethnic subgroups be explicitly excluded from participation? 
* No 
If Yes, identify subgroups and provide a justification: 
3.4  
 
For studies conducted in the U.S., do you expect that all subjects will be able to 
comprehend English? 
* Yes 
 
 
 
 
[reviewer notes,] 
 
3.5 
Participation of Children: Will children less than 18 years of age be studied? 
 
* No 
If No, provide a justification for excluding children: 
While it is possible for children under the age of 18 to become pregnant, this age range is 
not typically representative of the population that we wish to evaluate in this study. It is 
also more challenging for children under the age of 18 to provide accurate medical 
histories, comprehend the risks and benefits of the study and interventions, be cooperative 
during spinal or peripheral nerve block procedures (such as the QLB), and provide accurate 
feedback regarding their participation in the study. 
 
 
 
[reviewer notes-,] 
 
3.6 
Does this research study involve prisoners, or is it anticipated that the research 
study may involve prisoners? 
* No 
 
 
 
[reviewer notes,] 
 
3.7 
Will pregnant women be knowingly and purposely included in this research study? 
* Yes 
 


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3.7.1  
 
 
 
Where scientifically appropriate, preclinical studies, including studies on pregnant 
animals, and clinical studies, including studies on non-pregnant women, have 
been conducted and provide data for assessing potential risks to pregnant women 
and fetuses. [45 CFR 46.204 (a)] [Include references] 
 
* 
The experimental intervention in this study will be performing a quadratus lumborum block 
(QLB). This block will be performed at the conclusion of an elective cesarean section, thus 
at that time the baby will have already been delivered and the mother will no longer 
technically be pregnant. Furthermore, the risk of withholding intrathecal morphine from 
some patients will only affect pain control following delivery when the mother is no longer 
pregnant. There should therefore be no risks to the fetus at all as a result of this study. Any 
risks to the mother such as the potential for increased pain when not receiving intrathecal 
morphine and any possible side effects as a result of the QLB will occur after delivery and 
thus pose no risks to her pregnancy. 
cts! 
 
3.7.2  
 
The risk to the fetus is caused solely by interventions or procedures that hold out 
the prospect of direct benefit for the women or the fetus; or, if there is no such 
prospect of direct benefit, the risk to the fetus is not greater than minimal and the 
purpose of the research is the development of important biomedical knowledge 
which cannot be obtained by any other means. [45 CFR 46.204 (b)] 
* 
For the reasons described above in section 3.7.1, there should be no risks to the fetus as a 
result of this study. 
 
3.7.3 
Any risk is the least possible for achieving the objectives of the research. [45 CFR 
46.204 (c)] 
 
* 
II efforts are being taken during the design of this study, and will be during 
implementation, to ensure that any risks associated with this study are minimized as much 
as possible. 
3.7.4  
 
No inducements, monetary or otherwise, will be offered to terminate the 
pregnancy. [45 CFR 46.204 (h)] 
* 
No inducements of any type will be offered to terminate the pregnancy. 
 
3.7.5  
 
Individuals engaged in the research will have no part in any decisions as to the 
timing, method, or procedures used to terminate a pregnancy. [45 CFR 46.204 (i)] 
* 
No individual engaged in this research will have any part in anything related to the 
termination of pregnancy. The goal of all patients in this study will be the delivery of a living 
and healthy infant. 
 
3.7.6  
 
Individuals engaged in the research will have no part in determining the viability 
of a neonate. [45 CFR 46.204 (j)] 
* 
No individuals engaged in this research will have any role in determining the viability of any 
neonate. Viability of neonates is determined at Magee by neonatologists specialized in 
neonatal intensive care. 
following criteria. Describe how your study meets each of th jlg)irfi l'E@ n 3 - Human Sub je 


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!section: Section 3 - Human Subjects! 
[reviewer notes-,] 
 
 
3.8 
 Does this research study involve neonates of uncertain viability or nonviable 
neonates? 
* No 
 
 
 
 
[reviewer notes.] 
 
3.9 
Fetal Tissues: Does this research involve the use of fetal tissues or organs? 
* No 


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[reviewer notes-,] 
 
---> 
!section: Section 3 - Human Subjects! 
 
3.10  
 
What is the total number of subjects to be studied at this site, including subjects 
to be screened for eligibility? 
 
Note: The number below is calculated by summing the data entered in question 3.11. Any 
additions or changes to the values entered in 3.11 will be reflected in 3.10. 
* 60 
 
3.11  
 
Identify each of the disease or condition specific subgroups (include healthy 
volunteers, if applicable) that will be studied. 
Click on the "Add" button and specify for each subgroup: 
1) how many subjects will undergo research related procedures at this site; and 
2) if applicable, how many subjects will be required to undergo screening 
procedures (e.g., blood work, EKG, x-rays, etc.) to establish eligibility. Do Not 
include subjects who will undergo preliminary telephone screening. 
 
* 
Subgroup 
. 
Control (ITM plus sham 
View QLB) 
. 
Experimental (ITM plus 
-V-iew b upI•vacai•ne QLB) 
Number to undergo 
research procedures 
26 
 
26 
Number to undergo 
screening procedures 
30 
 
30 
 
 
 
 
3.12 
Provide a statistical justification for the total number of subjects to be enrolled 
into this research study at the multicenter sites or this site. 
* Described below: 
The primary outcome is the mean numeric rating scale (NRS) pain scores with activity at 24 
hours after completion of the quadratus lumborum block. Previous work comparing dynamic 
pain outcomes among women undergoing cesarean delivery with and without quadratus 
lumborum block 1 reported median [IQR] pain scores at 24 hours of 2[0-3] in the 
intervention group and 4[2-5] in the control group. Mean and standard deviation were 
estimated from this data using mean=median and SD = IQR/1.35.2 For 2 groups, a total 
sample of 60 subjects (26 in each group completed) is estimated to achieve 80% power to 
detect differences among the NRS means versus the alternative of equal means using an F 
test with a 0.05 significance level. The size of the variation in the means represented by the 
standard deviation is assumed to be 1.00, with a common standard deviation within a 
group of 2.22. To account for subject dropout and/or ineligibility, 60 subjects will be 
screened for randomization into 2 groups, with 30 subjects to be screened for each group. 
 
 
1. Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after 
caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812- 
8. 
2. Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, 
range, and the size of a sample. BMC Med Res Methodol. 2005 Apr 20;5:13. 


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[reviewer notes-,] 
!section: Section 3 - Human Subjects! 
 
 
3.13 
Inclusion Criteria: List the specific criteria for inclusion of potential subjects. 
 
Elective cesarean planned under spinal anesthesia 
Singleton pregnancy 
American Society of Anesthesiologists (ASA) classification score of 2 (or less) 
Gestational age of at least 37 weeks 
Intention to breastfeed infant 
 
3.14 
Exclusion Criteria: List the specific criteria for exclusion of potential subjects from 
participation. 
 
Contraindications to neuraxial blockade (such as clinically relevant coagulopathy, recent 
anticoagulant use, patient refusal, or localized skin infection overlying the site of needle 
entry) 
 
Anatomical abnormalities contraindicating spinal or QLB placement 
Received/Conversion to general anesthesia 
Received supplemental parenteral anesthesia (sedation) for any reason (e.g. unanticipated 
prolonged surgical procedure) 
 
History of chronic pain 
 
History of chronic opioid use/abuse 
 
 
 
3.15  
History of Subutex, methadone, other maintenance therapy 
 
Will HIV serostatus be evaluated specifically for the purpose of participation in 
this research study? 
* No 
 
If Yes, provide a justification: 


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[reviewer notes-,] 
!section: Section 4 - Recruitment and Informed Consent Procedures! 
 
 
4.1 
Select all recruitment methods to be used to identify potential subjects: 
Other Strategies: Described below 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.2 
 
Provide a detailed description of your recruitment methods, including identifying 
and initiating contact with participants: 
II subjects approached for enrollment into this study are patients being seen by 
investigators during the course of normal clinical care. Screening of potential patients will 
occur by obstetirical OR schedule. After review, potential patients will havetelephone 
contact with subjects 2-3 days prior to the scheduled elective surgery. 
 
The day of surgery the Anesthesia care team sees the patient. The current process at 
Magee Women's Hospital is for the anesthesia team to see all patients who come in for 
scheduled, elective cesarean deliveries in the pre-op holding area approximately 20-60 
minutes before the scheduled start of their cesarean. During this visit, we typically review 
their history with them, explain the anesthetic plan, and obtain consent for the anesthesia. 
 
For this study, for eligible participants, we will also utilize this visit to also explain the study 
to them; the risks and benefits of QLB and of participation will be explained, and a waiting 
period achieved as previously described. Informed consent will then be obtained from 
accepting participants, as screened and addressed with prior phone call. The study will be 
described and consent obtained by either the PI or one of the listed co-investigators for the 
study. 
 
 
 
 
Note: Questions jump from 4.2 to 4.6 as questions 4.3-4.5 have been removed and the information is now 
captured in 4.1 
[reviewer notes-,] 
 
4.6 
 Are you requesting a waiver to document informed consent for any or all 
participants, for any or all procedures? ( e.g., a verbal or computerized consent 
script will be used, but the subjects will not be required to sign a written informed 
consent document. This is not a waiver to obtain consent. 
* No 


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General Requirements: The Federal Policy [45 CFR 46.116 (d)] specifies in order for a 
waiver of consent to be approved, the request must meet four criteria. For each request, 
you will be asked to provide a justification addressing how each of these criterion is met. 
 
 
[reviewer notes-,] 
!section: Section 4 - Recruitment and Informed Consent Procedures! 
 
 
4.7 
 Are you requesting a waiver to obtain informed consent or an alteration of the 
informed consent process for any of the following? 
 
 
 
* No 
 
4.7.1 
If Yes, select the reason(s) for your request: 
There are no items to display 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
[reviewer notes-,] 
 
4.8  
 
Are you requesting an exception to the requirement to obtain informed consent 
for research involving the evaluation of an 'emergency' procedure? 
Note: This exception allows research on life-threatening conditions for which available 
treatments are unproven or unsatisfactory and where it is not possible to obtain informed 
consent. 
* No 


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[reviewer notes-,] 
!section: Section 4 - Recruitment and Informed Consent Procedures! 
 
 
4.9  
 
Upload all consent documents for watermarking: 
 
 
Draft Consent Forms for editing: 
 
Name 
Modified Date 
 
 
Informed Consent Form track changes revision 7/26/2017 3: 23 PM 
 
 
 
Approved Consent Form(s): 
Name 
Modified Date 
 
 
Informed Consent Form track changes revision 7/26/2017 3: 23 PM 
 
[reviewer notes-,] 
 
4.10 
 Will all potential adult subjects be capable of providing direct consent for study 
participation? 
 
* 
Yes 


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[reviewer notes-,] 
!section: Section 4 - Recruitment and Informed Consent Procedures! 
 
 
4.11  
 
At what point will you obtain the informed consent of potential research subjects 
or their authorized representative? 
 
After performing certain of the screening procedures, but prior to performing any of the 
research interventions/interactions 
 
 
4.11.1  
Address why you feel that it is acceptable to defer obtaining written informed 
consent until after the screening procedures have been performed. 
 
The "screening procedures" that will be involved in this study simply involve confirming that 
it is a singleton pregnancy at 37 weeks gestational age or greater and that there are no 
contraindications to neuraxial blockade or performing a quadratus lumborum block. All of 
this information will be easily obtained by talking to the patient during the routine 
anesthesia visit that occurs prior to any scheduled cesarean. If during this visit, the patient 
is noticed to meet all of the inclusion and exclusion criteria, then the study will be explained 
to them and consent for the study obtained. If during this visit, the patient is noticed to not 
meet the inclusion and exclusion criteria, then we will not explain the study to them and will 
instead just proceed with routine care for their cesarean. Whether patients participate in the 
study or not, investigators will still be part of their anesthesia care team. 
 
4.11.2 
 
Taking into account the nature of the study and subject population, indicate how 
the research team will ensure that subjects have sufficient time to decide whether 
to participate in this study. In addition, describe the steps that will be taken to 
minimize the possibility of coercion or undue influence. 
II potential study participants will be contacted subjects will be contacted 2-3 days prior to 
the procedure. They will have discussion of the study to allow for decision for participation. 
This should give ample time to describe the study, answer any questions. The day of 
surgery, patients will also be approached and look over the consent. It will be made clear to 
the patients that their participation is completely voluntary and that any refusal to 
participate will not affect their care in any way. We perform a large number of elective 
cesareans at Magee, thus even if many refuse we still anticipate no challenges in getting the 
numbers we need for the study. Any coercion or undue influence to obtain participants would 
be neither ethically or morally desired, nor at all necessary to complete the study in a timely 
fashion. 
 
 
 
 
[reviewer notes,] 
 
4.12 
Describe the process that you will employ to ensure the subjects are fully 
informed about this research study. 
* Not applicable; see previous request for a waiver of informed consent for all aspects of 
this research study (question 4.7) 
This description must include the following elements: 
•  who from the research team will be involved in the consent process (both 
the discussion and documentation); 
• person who will provide consent or permission; 
• information communicated; and 
• any waiting period between informing the prospective participant about the study 
and obtaining consent 
In addition, address the following if applicable based on your subject population: 
• process for child assent and parental permission 


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0 
continued partici ll!>riif: <Eebtl@ 
att.111!mMltchtftflD7 4N!i:m!;ent Procedures! 
• process for obtaining proxy consent and assent for decisiona y impaired subjects 
o  continued participation if subject regains capacity to consent 
 
Once the patient has confirmed booking for a scheduled, elective cesarean, they will be 
contacted 2-3 days prior to the scheduled C-section. Then a discussion will be made to 
describe the study, answer questions related to procedures and, if the subject is interested, 
indicate the informed consent process will take place in the pre-op hold area the day of 
surgery. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.13  
The day of surgery, the patient will approached by either the PI or another physician listed 
as a co-investigator for this study, who will be responsible for both discussing the study and 
documenting the consent. The patients themselves will be the ones to provide the consent. 
PI and the other physician co-investigators are all part of the L&D anesthesia care team, 
and will be part of the team providing clinical care to the patient regardless of whether they 
choose to participate in the study or not. Information communicated will include the risks 
and benefits of spinal anesthesia for cesarean, including the risks and benefits of receiving 
the current standard of care for post-operative pain. The quadratus lumborum block (QLB) 
will also be discussed in detail including how the procedure is performed and the risks and 
benefits of having it done. The patient's medical history will be reviewed with them in the 
usual fashion as is already routinely done by the anesthesia team prior to any scheduled 
cesarean. Once the patient has been fully informed regarding the study and anesthetic 
plan, and all questions have been answered, they will be given the consent form with 
enough time to review it in its entirety. Once they are satisfied with the consent and all of 
the information they have received, and all of their questions have been answered, they will 
then be asked to sign the consent form if they wish to participate. Thus, informing them 
about the study and explaining the consent will both be done at the same visit, and the 
amount of time of time between them should be minimal (it will only be determined by how 
many questions the patient has and how much time they would like to spend looking over 
the consent form prior to signing). If they wish, they can keep the consent form to consider 
things for as long as they wish prior to signing, and the research team will respect that 
time. 
 
Are you requesting an exception to either IRB policy related to the informed 
consent process? 
• For studies involving a drug, device or surgical procedures, a listed physician 
investigator is required to obtain the written informed consent unless an exception to 
this policy has been approved by the IRB 
• For all other studies, a listed investigator is required to obtain consent (Note: In 
order to request an exception to this policy, the study must be minimal risk) 
 
* No 
If Yes, provide a justification and describe the qualifications of the individual who will 
obtain consent: 
 
 
 
4.14 
 Will you inform research subjects about the outcome of this research study 
following its completion? 
 
* No 
If Yes, describe the process to inform subjects of the results: 


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[reviewer notes-,] 
!section: Section 5 - Potential Risks and Benefits! 
 
 
5.1 
 
Describe potential risks (physical, psychological, social, legal, economic or 
other) associated with screening procedures, research interventions/interactions, 
and follow-up/monitoring procedures performed specifically for this study: 
* 
 
Research Activity: 
Common Risks: 
Infrequent Risks: 
Other Risks: 
 
Access to PHI 
No Value Entered 
Breach of confidentiality 
No Value Entered 
View 
Research Activity: 
Common Risks: 
Infrequent Risks: 
Other Risks: 
 
Bupivacaine 
 
No Value Entered 
No Value Entered 
Maternal: Restlessness, anxiety, dizziness, tinnitus, blurred vision, or 
tremors, depression of the myocardium, decreased cardiac output, 
heartblock, hypotension, bradycardia, ventricular arrhythmias, 
allergic type reactions. Newborn: Infant lethargy after breastfeeding. 
Research Activity: 
Common Risks: 
Infrequent Risks: 
Other Risks: 
 
Follow-up: Pain and Breastfeeding Questions 
Inconvenience 
Loss of confidentiality 
 
frustration or embarrassment (if breastfeeding is unsuccessful). 
Research Activity: 
Common Risks: 
Infrequent Risks: 
Other Risks: 
 
Research intervention -quadratus lumborum block 
 
No Value Entered 
 
bleeding, infection, damage to surrounding structures 
 
No Value Entered 
Research Activity: 
Common Risks: 
Infrequent Risks: 
Other Risks: 
 
Screening procedures 
No Value Entered 
Loss of confidentiality 
No Value Entered 
 
 
 
5.1.1 
Describe the steps that will be taken to prevent or to minimize the severity of the 
potential risks: 
 
 
The quadratus lumborum block (QLB) will be performed by anesthesiology physicians 
trained in the procedure in the OR in a sterile fashion (sterile prep, sterile gloves, sterile 
field) to minimize any risk of infection. It will be performed under ultrasound guidance to 
minimize the risk of any damage to surrounding structures or bleeding. A low concentration 
of local anesthetic has been chosen for the block, and the total amount administered will be 
within the known safe total dosage. 
 
To minimize the risks of loss of confidentiality, any data collected by any interactions with 
participants for the purpose of this research will be stored on departmental computers 
(password protected, secure servers) or in locked cabinets in faculty offices. Data will be 


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de-identified for name, MRN, date of birth, and other identifiers prior to analysis. 
 
5.2 
 
What steps will be taken in the event that a clinically significant, unexpected 
disease or condition is identified during the conduct of the study? 
* Addressed below: 
Any unexpected diseases or conditions identified during the conduct of this study will be 
handled in the usual, routine manner. The anesthesia team remains on the labor and 
delivery floor 24/7 and is responsible for following the patient throughout their delivery and 
identifying and managing any complications that may arise. This process will not change as 
a result of this study. Patients enrolled in this study will also have close follow-up, 
particularly in the firs 2 hours following their procedure, and any patients having a cesarean 
typically remain inpatient for at least two days. If anything comes up, there will be a trained 
anesthesia provider immediately available to assess and if necessary treat the patient. If 
any other specialties need to be consulted for any reason that can be easily done as well. 
Any complications that may arise after the patient has been discharged from the hospital 
are not anticipated, however, should they arise, the patient will have the contact 
information of the anesthesia service with the ability to contact us 24/7 with any questions 
or concerns. 
 
 
5.3 
All the risk questions (screening, intervention/interaction, follow-up) have been merged into 
one question (5.1). 
[reviewer notes,] 
 
5.4 
Do any of the research procedures pose a physical or clinically significant 
psychological risk to women who are or may be pregnant or to a fetus? 
* No 
 
 
 
[reviewer notes,] 
 
5.5 
Do any of the research procedures pose a potential risk of causing genetic 
mutations that could lead to birth defects? 
* No 
 
 
 
[reviewer notes,] 
 
5.6  
 
Are there any alternative procedures or courses of treatment which may be of 
benefit to the subject if they choose not to participate in this study? 
* Yes - Describe below: 
 
If Yes, describe in detail: 
If a subject chooses not to participate in the study, they will receive standard of care which 
includes spinal anesthesia with ITM, multimodal postoperative analgesia as described, and 
no QLB. 


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Describe the specific endpoints (e.g., adverse reactions/events, failure to 
demonstrate effectiveness, disease progression) or other circumstances 
(e.g., subject's failure to follow study procedures) that will result in discontinuing 
a subject's participation? 
* Describe below: 
 
Discontinuing a subject's participation may result if the subject refuses to follow any of the 
study protocols (e.g. if they are assigned to the quadratus lumborum block group but then 
change their mind and do not allow the block to be performed), or if there is any other 
breach in protocol. They will also be withdrawn if there is an alteration in their clinical 
condition leading to a change in anesthetic plan such as the need to convert to general 
anesthesia. Study subjects may also voluntarily choose to withdraw from the study at any 
time without prejudice to their care. 


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Will any individuals other than the investigators/research staff involved in the 
conduct of this research study and authorized representatives of the University 
Research Conduct and Compliance Office (RCCO) be permitted access to research 
data/documents (including medical record information) associated with the 
conduct of this research study? 
* Yes 
 
5.8.1 
 
Identify the 'external' persons or entity who may have access to research 
data/documents and the purpose of this access: 
Research data may be shared with secondary investigators with similar research interests 
as well as authorized representatives of UPMC hospitals, court of law and DHHS. 
 
5.8.2 
 
 
 
 
 
 
 
 
 
5.9 
 
Will these 'external' persons or entity have access to identifiable research 
data/ documents? 
* 
No; the research data/documents will be coded and subject identifiers removed prior to 
access by the external persons 
 
If Yes, describe how they will protect the confidentiality of the research data: 
 
Has or will a Federal Certificate of Confidentiality be obtained for this research 
study? 
* No 
 
5.10 
 
Question has been moved to 5.17 
 
5.11 
 
Question has been moved to 5.16 


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[reviewer notes-,] 
 
5.12 
 Does participation in this research study offer the potential for direct benefit to 
the research subjects? 
 
Yes - Describe the direct benefit that subjects may receive as a result of study participation. 
Indicate if all, or only certain, of the subjects may derive this potential benefit. 
 
Describe the benefit: 
II patients participating in this study have the potential to receive direct benefit in the form 
of possible improved pain control following the procedure. Improved pain control can also 
lead to other direct benefits such as having an easier time breastfeeding, being better able 
to bond with and care for their newborn earlier, and potentially being ready for discharge 
from the hospital sooner. 
5.13 
 Describe the data and safety monitoring plan associated with this study. If the 
research study involves multiple sites, the plan must address both a local and 
central review process. 
 
The incidence of any adverse events including any potential complications related to the 
quadratus lumborum block or inadequate post-operative pain control in any study group will 
be monitored and documented daily. Any adverse events will be immediately reported to 
the PI. Any serious adverse event resulting from this study (which are extremely unlikely) 
would be immediately reported by the PI to the IRB and appropriate action taken. All 
collected data will be de-identified and stored on departmental computers on secure servers 
and accessible only by the PI. The PI will have full oversight of the data and safety 
monitoring plan (DSMP), and will participate along with the other listed co-investigators in 
the local data safety monitoring. The DSMP will include monitoring for breach of 
confidentiality, deviations, data safety, changes to risk / benefit ratio, progress of the study, 
recruitment and retention, timeliness and quality of the data, AEs, UAPs, and subject 
withdrawals. The monitoring will occur continually during the study with each enrollment of 
a new subject, and is being completed to maintain the safety of all participants. All Data 
and Safety Monitoring meeting reports will be submitted to the IRB at the time of study 
renewal. 
[reviewer notes-,] 
Section 5 - Potential Risks and Benefits of Study Participation 
5.14  
 
What precautions will be used to ensure subject privacy is respected? (e.g. the 
research intervention will be conducted in a private room; the collection of sensitive 
information about subjects is limited to the amount necessary to achieve the aims of the 
research, so that no unneeded sensitive information is being collected, drapes or other 
barriers will be used for subjects who are required to disrobe) 
 
Data collection will be limited to the minimum amount necessary to achieve the aims of the 
research, and the large majority of the information that will be screened for in this study is 
information that is already routinely screened during routine care. All patient interactions 
including the initial screening and consenting, spinal placement, quadratus lumborum block 
placement, and follow-up evaluation will be conducted while the patient is admitted to the 
hospital in either the pre-op holding area, operating room, recovery room, or their private 
patient room. Any documented patient information will be de-identified at the time of it 
being recorded and only the key (accessible only by PI) will be able to link it to specific 
patients. Patient privacy/modesty during the spinal and quadratus lumborum block 
procedures will be handled in the same standard fashion as it routinely is and includes 
keeping the patient covered as much as is possible. 
 
 
 
 
 
 
5.15  


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Go to the A-Z Guidance, download the Data Security Assessment Form, complete, and 
upload using the Add button below. Depending on the data type, you may need to consult 
with your data manager to address some of the sections. Email irb@pitt.edu if you have 
any questions. 
Name 
 
What precautions will be used to maintain the confidentiality of the research data 
during collection, transmission and storage? It is important that you indicate the 
data security measures for all data types. 
 
* Upload Data Security Form: 
 
Data Security Form 2/9/2017 11:53 AM 
Address what precautions will be used to maintain the confidentiality of the 
research data collected in paper format if applicable: 
The system for maintaining patient confidentiality will be to immediately code patient 
information. Once enrolled, each patient will be given a study ID number. Paper data 
collection forms will then be used which contain the study ID number and blank spaces to 
document the relevant data. Other than the study ID number, no other information that can 
identify the specific patient will be included on the data collection form. All paper data 
collection forms will be stored in a locked file cabinet in the locked UPMC office of the PI. A 
single electronic master list connecting each study ID number to the specific patient will be 
kept on a password protected spreadsheet on a password protected UPMC desktop 
computer with a secure server behind the UPMC firewall. 
 
5.15.1 
 
Does your research study require a data security review? Answer Yes if any of the 
following conditions are met: 
• Identifiable or *coded data will be collected, stored, or transmitted using any of the 
following technologies: mobile app, web-based site or survey, wearable device, text 
messaging, electronic audio, photographic, or video recording or 
conferencing and/or 
• The IRB requested a data security review during their review of the study 
* Yes 
 
 
 
5.16  
 
If the subject withdraws from the study, describe what, if anything, will happen to 
the subject's research data or biological specimens. 
If a subject withdraws from the study, they will be informed that any study data collected 
up to that point will be kept and reported, but that no new study data will be obtained or 
documented. 
 
5.17  
 
Following the required data retention period, describe the procedures utilized to 
protect subject confidentiality. (e.g., destruction of research records; removal of 
identifiers; destruction of linkage code information; secured long-term retention) 
Following the required data retention period, the electronic key linking each individual 
patient to their collected data (stored in a secure, locked location) will be destroyed. 
Individual, coded, data collection sheets will be maintained indefinitely in a secure and 
locked location for a minimum of seven years after final reporting or publication of a 
project. Following the required retention period they too will be destroyed. No collected 
data will be kept longer than what is required. 
*Coded: Identifying information (such as name) that would enable the investigator to 
readily ascertain the identity of the individual to whom the private information or 
specimens pertain has been replaced with a code (number, letter, symbol, or any 
combination) and a key to decipher the code exists, enabling linkage of the identifying 
information to the private information or specimens 


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[reviewer notes-,] 
!section: Section 6 - Costs and Payments! 
 
 
 
 
6.1 
 
Will research subjects or their insurance providers be charged for any of the 
procedures ( e.g., screening procedures, research procedures, follow-up 
procedures) performed for the purpose of this research study? 
* 
No 
 
 
 
 
[reviewer notes-,] 
 
 
6.2 
 Will subjects be compensated in any way for their participation in this research 
study? 
* No 


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[reviewer notes-,] 
!section: Section 7 - Qualifications and Source(s) of Support! 
 
 
7.1 
 
Summarize the qualifications and expertise of the principal investigator and listed 
co-investigators to perform the procedures outlined in this research 
study. 
 
The principal investigator, Nicholas Schott, MD is a staff anesthesiologist at Magee Women's 
Hospital o the OB team. He is fellowship trained in acute pain and regional anesthesia. As 
an acute pain doctor, he performs a wide variety of peripheral nerve blocks daily and has 
extensive experience performing the quadratus lumborum block. 
 
Jonathan Waters, MD is an attending anesthesiologist and the chief at the department of 
anesthesiology at Magee Women's Hospital. He is also the director of the Clinical Trials 
Program at UPMC. He has extensive experience in all aspects of the anesthetic management 
of obstetric patients and has performed numerous spinal procedures and peripheral nerve 
blocks over his career. 
 
Grace Lim, MD is an attending obstetric anesthesiologist and the current director of 
obstetrical anesthesia at Magee Women's Hospital. Her subspecialty training in clinical 
obstetrical anesthesia, coupled with additional formal research training toward a Master of 
Science in clinical research makes her well-suited to inform the study design and execution 
of this trial. She has a track record of successful protocol development, implementation, 
study team coordination, and/or publication for clinical studies and trials in the obstetric 
population. 
 
Patricia Dalby, MD is a current attending obstetric anesthesiologist and the current director 
of the obstetric anesthesiology fellowship program at Magee Women's Hospital with 
extensive clinical obstetric anesthesia experience for >20 years. She has significant 
experience in the anesthetic management of obstetric patients throughout the puerperium. 
 
Thomas Vernon, MD is a former Obstetrical Anesthesiology fellow who has completed 
training the the specifics and management of complex obstetrical anesthesia care. This 
includes a high risk procedures as well ad a grand expertise in preforming obstetrical 
anesthesia. He is also a contributor to this project from the start. His current association is 
as a staff anesthesiologist for the Arizona Anesthesiologists Consultants group in Arizona, 
USA. 


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[reviewer notes-,] 
!section: Section 7 - Qualifications and Source(s) of Support! 
 
 
7.2 
Indicate all sources of support for this research study. 
 
* 
Selections 
Internal: Department funds 
 
 
 
 
If Federal support, provide the sponsor information: 
Federal sponsor Grant Title Grant number Awardee institution Federal grant application 
 
 
 
For projects not supported by a federal grant, upload the research plan that was submitted 
for funding: 
Name Modified Date 
 
 
If Industry support, provide the sponsor information and level of support: 
N/A 
 
 
 
If Foundation support, provide the sponsor information: 
N/A 
 
 
If Other support, provide the support information and level of support: 
N/A 


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[reviewer notes-,] 
!section: Section 7 - Qualifications and Source(s) of Support! 
 
 
 
7.3 
 
Is this study funded in part or whole by a PHS Agency? 
* No 
 
 
Does any investigator* involved in this study (select all that apply): 
Name 
 
 
A. Have equity in a publicly-traded entity that either sponsors** this research or 
 owns the technology being evaluated or developed that exceeds a 5% ownership 
interest or a current value of $10,000? 
 
 
B. Have equity in a non-publicly-traded entity that either sponsors this research 
or owns the technology being evaluated or developed? 
 
C. Receive salary, consulting fees, honoraria, royalties or other remuneration from an 
 entity that either sponsors this research or owns the technology being evaluated or 
developed that is expected to exceed $10,000 during the past or next 12 months? 
 
 
D. Have rights as either the author or inventor of intellectual property being 
 evaluated or developed in this research that is the subject of an issued patent or has 
been optioned or licensed to an entity? 
 
 
E. Have an officer or management position**** with a Licensed Start-up Company 
 overseen by the COI Committee that either sponsors this research or owns the 
technology being evaluated or developed? 
 
 
F. Receive compensation of any amount when the value of the compensation would be 
affected by the outcome of this research, such as compensation that is explicitly 
 greater for a favorable outcome than for an unfavorable outcome or compensation in 
the form of an equity interest in the entity that either sponsors this research or owns 
the technology being evaluated or developed? 
 
 
None of the above options apply and there are no other financial conflicts of 
interest in the conduct of this research. 
*Investigator means the PI, co-investigators, and any other member of the study team, 
regardless of title, who participates in the design, conduct, or reporting of this research, as 
well as his/her spouse, registered domestic partner, dependents, or other members of 
his/her household. The PI is responsible for ensuring that s/he and all other 
relevant members of the study team review the above questions describing 
Significant Financial Interests. 
**through the provision of funds, drugs, devices, or other support for this research 
****Such as serving on the Board of Directors or Board of Managers or a position that 
carries a fiduciary responsibility to the company (e.g., CEO, CFO, CTO, or CMO). 


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[reviewer notes-,] 
 
 
 
 
 
Supporting Documentation Section 
References and Other Attachments 
!section: Supporting Documentation! 
 
 
Additional documents: 
Name 
Modified Date 
QLB Study 
12/20/2016 
References 
1: 00 PM 
Ramsay 
 12/20/2016 
Sedation Scale 
4:46 PM 
 
Version 
0.01 
0.01 
Please use the Add button to the left to upload additional 
documents if needed. 
 
 
 
[reviewer notes-,] 
 
Clinica/Trials.gov is a registry and results database of publicly and privately supported 
clinical studies of human participants conducted around the world. 
 
"Applicable clinical trials" are required by federal law to be registered in ClinicalTrials.gov. 
Applicable Clinical Trials (ACTs) are studies that meet the following criteria: 
• The study is an interventional study AND 
• The study intervention is a drug, biologic, medical device, radiation or genetic AND 
• The Study is not Phase 0 or 1 AND 
• The study has at least one site in the United States or is conducted under an investigational 
new drug application or investigational device exemption 
NIH Policy 
Effective January 18, 2017, revised NIH Policy requires that all clinical trials funded in whole or in 
part by the NIH be registered and results information posted on ClinicalTrials.gov. 
As defined by the NIH, a clinical trial is: 
A research study in which one or more human subjects are prospectively assigned to one or 
more interventions (which may include placebo or other control) to evaluate the effects of 
those interventions on health related biomedical or behavioral outcomes. 
 
The NIH Policy extends beyond the Food and Drug Administration Amendment Act (FDAAA 801) 
requirements in that it requires registration and results reporting of: 
• clinical trials of behavioral, surgical and other types of health and medical interventions 
• phase 1 studies of drugs and biological products 
• small feasibility studies of device products 
Failure to submit all required registration and results information requested on ClinicalTrials.gov can 
jeopardize University grant funding, the future funding of the grantee and subject the University of 
Pittsburgh to future monetary penalties. 
In addition, to promote transparency of the clinical trials process, the International Committee of 
Medical Journal Editors (ICMJE) has established a policy requiring the entry of clinical trials in a 
public registry, such as ClinicalTrials.gov, prior to subject enrollment as a condition of consideration 
for publication of the trial results. 
 
* Based on the above information, will this study be registered in ClinicalTrials.gov? 


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If you are not yet registered and need to establish an account for the PI or other research staff that 
may need to access the record, please send an email to the University of Pittsburgh PRS 
administrator at ctgov@pitt.edu with the following information for each individual: 
• Full name 
• Telephone number 
• Pitt or UPMC email address 
If you have any questions or concerns, please email us at ctgov@pitt.edu. 
To find out additional information about how to register your study go to: 
https://www.clinicaItrials.gov/ ct2/ma nage-recs/how-register 
Yes 
!section: Supporting Documentation! 
 
 
 
 
Who will serve as the Responsible Party? UPMC/Pitt Investigator or IND/IDE Pitt Sponsor 
Why are you registering your study? (Check all that apply) 
It is strongly encouraged by the NIH 
It is required for publication by the International Committee of Medical Journal Editors ( 
Registration is required in a publically available, searchable database system prior to informed 
consent being obtained from the first study participant)