Clinical trial NCT04588389
Conditions: Pain Opioid Use Lumbar Disc Herniation
Keywords: Lumbar Spine Nerve Block Opioid Use Pain
Sponsor: University of Massachusetts, Worcester
Start date: 2020-12-01; Completion date: 2021-05-14
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the quality of analgesia and reduction of opioid use, between standard of care and two groups of local anesthetic blocks in different location in the quadratus lumborum plane, for postoperative pain control after lumbar spinal fusion and if it reduces opioid consumption.

Detailed description:
This study is a pilot study as part of planning for a larger randomized controlled trial. The study plans to enroll a total of 30 patients, with 10 patients randomly assigned in each group of the study. Group I will receive the standard of care multimodal pharmacological management. Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block. Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. Measurements of opioid use, pain, and side effects will be recorded for each patient.

Arms: arm 1: Group I will receive the standard of care multimodal pharmacological management. arm 2: Group II will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum II local anesthetic block. arm 3: Group III will receive standard of care multimodal pharmacological management plus the Quadratus Lumborum III local anesthetic block. We will measure opioid use, pain, and side effects in each patient.
Interventions: intervention 1: Ropivacaine injection Location 1 intervention 2: Ropivacaine injection Location 2 intervention 3: Multimodal Pharmacological Management
Intervention descriptions: intervention 1: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1 intervention 2: Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2 intervention 3: standard of care multimodal pharmacological management

Protocol documents:
ICF_002.pdf: 
Comparison of Quadratus Lumborum Blocks with Medical Management for Pain Control after Lumbar 
Spine Fusion Surgery 
NCT04588389 
Document Date/IRB Approval: 04/20/21 


UMMS Template 06.01.18 
ICF Version 3.0 dated 12.30.2020 
Page 2 of 
Approved UMass Medical School IRB Do not sign this form after this date: 4/20/2021 
 
 
 
 
 
 
UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH 
 
CONSENT TO PARTICIPATE IN A RESEARCH STUDY 
 
Title: H00016236: Comparison of Quadratus Lumborum Blocks with Medical Management for 
Pain Control after Lumbar Spine Fusion Surgery 
 
Sponsor: Department of Anesthesiology 
 
Investigator: Eman Nada, MD 
 
UMass Memorial Medical Center 
 
55 Lake Ave North, Department of Anesthesiology 
Worcester, MA 01655 
Daytime Phone Number: 774-285-5164 
 
Consent Version: Version 3.0 dated 12.30.2020 
 
Subject’s Name: 
Date: 
 
You are being invited to take part in a research study. Someone will explain this research to you. 
This form helps to sum up their explanation. 
 
In this form, “you” generally refers to the person who takes part in the research. If you are being 
asked as the legally authorized representative, parent, or guardian to allow someone else to take 
part, “you” in the rest of this form generally means that person. 
 
 
KEY INFORMATION 
You are being invited to participate in a research study because you are having elective 
spinal fusion surgery. 
If you have questions or don’t understand something, please ask. 
Taking part in this research is voluntary and completely up to you. You are free to say no or to 
leave the research at any time. There will be no penalties or changes in the quality of the health 
care you receive, and you will not lose any benefits to which you are otherwise entitled. 
The main purpose of this study is to try and answer the question whether or not injections of a 
local anesthetic to block nerve pain (also known as a nerve block) following spinal fusion 
surgery in addition to usual pain management treatments are more effective in managing pain 
than just the usual intravenous pain medications alone. Severe pain immediately following 
spinal fusion surgery delays patients from getting up and moving after surgeryas well as delays 
rehabilitation and decreases overall patient satisfaction with their experience immediately 


UMMS Template 06.01.18 
ICF Version 3.0 dated 12.30.2020 
Page 3 of 
Approved UMass Medical School IRB Do not sign this form after this date: 4/20/2021 
 
 
following surgery. The excessive use of opioids for pain management following surgery is one 


UMMS Template 06.01.18 
ICF Version 3.0 dated 12.30.2020 
Page 4 of 
Approved UMass Medical School IRB Do not sign this form after this date: 4/20/2021 
 
 
of the causes of the current opioid epidemic. Finding alternates ways to manage pain can 
potentially decrease opioid consumption and would be a valuable step in curbing this problem. 
The goal of this research study is to assess whether getting a nerve block in addition to the 
standard pain management therapy will result in a reduced use of opioids and provide better pain 
control following surgery than standard pain management treatment alone. 
The Quadratum Lumborum Block (QL) is an injection of a local anesthesia into an area directly 
next to the Quadratum Lumborum muscle in the lower back. It is successfully used for treating 
pain following abdominal surgery by blocking nerve pain. The injection would not interfere with 
the spinal fusion surgery site. 
If you join this research, you will be randomly assigned (like pulling a name out of a hat) to 
receive either: 
• Standard of Care Therapy: You will receive IV pain medication in the form of opioids, 
and Ketorolac immediately following surgery while you recover from anesthesia. After 
spending sometime in the recovery room, you will be moved to a regular hospital floor. 
Your pain management there will include opioids, Tylenol with or without Ketorolac as a 
pill that you would swallow or by injection. 
• QL 2 block: You will receive Standard of Care therapy described above AND a QL 2 
Block (Quadratum Lumborum Nerve Block injection to the area behind the muscle) 
• QL 3 block: Standard of Care therapy described above AND QL 3 Block (Quadratum 
Lumborum Nerve Block injection to the area in front of the muscle) 
You may not want to be in this study if you are uncomfortable with: 
• The fact that neither you nor your doctor will get to pick which group you are in 
• Sharing your private information with researchers 
 
Risks: 
If you are randomized to the nerve block groups, you may feel discomfort when the needle is 
placed to start the nerve block. On rare occasions patients may develop temporary mild leg 
weakness. This weakness improves in few hours when the local anesthetic effect wears off. In 
that case you should not get out of bed without assistance, until the weakness resolves. Other 
possible extremely rare risks include: infection, swelling and/or bruising caused by a small 
amount of bleeding into surrounding tissue at injection siteand persistent neuropathy (tingling, 
numbness, or temporary weakness in your legs or feet). This is a risk for anyone undergoing a 
nerve block. This risk is extremely rare occurring in only 0.04% of patients, meaning four in one 
thousand. If any complications happen it will be dealt with immediately as needed. We will take 
steps to protect your personal information. However, there is a risk of breach of confidentiality. 
There may also be risks that we do not know yet. 
 
Benefits: 
We cannot promise any benefits if you take part in this research. Your participation will help us 
to gain knowledge that may help other patients with pain relief after surgery. 


UMMS Template 06.01.18 
ICF Version 3.0 dated 12.30.2020 
Page 5 of 
Approved UMass Medical School IRB Do not sign this form after this date: 4/20/2021 
 
 
Alternatives: Your other choice is to receive the standard of care postoperative treatment. 
If you think you might like to participate in this research, please continue reading to learn 
more about the details of this study. 
STUDY DETAILS 
How many people will take part in this research? 
About 30 people will take part here at UMass Memorial Campus 
How long will I be in this research? 
You are expected to participate in the study until you are discharged from the hospital. 
What happens if I say yes, I want to be in this research? 
After obtaining consent from you, you will be randomized to 1 of 3 groups by chance (like 
pulling names out of a hat). 10 people will be in each group. You or your doctor cannot choose 
your study group. The 3 study groups are: 
• Standard of Care Therapy: You will receive IV pain medication in the form of opioids, 
and Ketorolac immediately following surgery while you recover from anesthesia and 
once you are awake and moved to a regular hospital floor you will receive the opioids, 
and Tylenol with or without Ketorolac as a pill that you would swallow. 
• QL 2 block: Standard of Care therapy described above AND QL 2 Block (Quadratum 
Lumborum Nerve Block injection to the area behind the muscle) 
• QL 3 block: Standard of Care therapy described above AND QL 3 Block (Quadratum 
Lumborum Nerve Block injection to the area in front of the muscle) 
You will be evaluated before surgery to make sure that you still meet the criteria for the study. 
Standard of care anesthesia medications will be given to you in the operating room by your 
anesthesiologist. If you are in the group that will receive an injection you will receive it after the 
surgery is completed. This can happen either before or after you wake up in the recovery room. 
If you are randomized to receive either the QL 2 block or the QL 3 block, your hip will be raised 
up on the side of the intended injection. That side will be scrubbed using a disinfectant solution. 
Then using a sterile ultrasound probe, the intended point of injection will be defined, then that 
point will be numbed with a very small needle, after that another needle will be used to inject the 
local anesthetic medications in the target point in front of or behind the muscle as decided by the 
randomization envelope. The procedure will then be repeated on the other side of your body. 
Your vital signs will be recorded every 5 minutes for 30 minutes after the procedure. Your pain 
score will be recorded using the VAS (Visual Analog Scale) where you will rate your pain from 
zero to 10. The sensations in your legs will be examined by testing you reaction to cold 
sensations and the strength of your leg movement will be evaluated by asking you to move your 
legs in certain directions. 
We will track and collect the data of your pain scores and the medications you used following 
surgery while you stay in the hospital as well as any side effects or adverse experiences that you 
had experienced while you were involved in the study. 
During the research, you, your surgeon and your postoperative care team will not know which 
group you are in. However, your study doctor can find out in case of an emergency. 


UMMS Template 06.01.18 
ICF Version 3.0 dated 12.30.2020 
Page 6 of 
Approved UMass Medical School IRB Do not sign this form after this date: 4/20/2021 
 
 
 
 
Will you be collecting any specimens from me? 
No, we will not be collecting any samples for purposes of this study. 
 
Could being in this research hurt me? 
The standard medication management has been used for years and it’s safety is known. Side 
effects like nausea, vomiting, drowsiness are not common. While severe side effects like 
stopping breathing and kidney injury are possible they are rare. 
• For the injection, you might feel some pressure, pain or discomfort at the introduction 
site of the needle to place the nerve block. You could develop a harmless black and blue 
mark or experience mild soreness at the injection site. 
• A possible yet rare side effect is temporary mild leg weakness. If this happens it should 
be mild and reversible within a few hours after the local anesthetics wears off. However, 
we use low concentration of the local anesthetic so the effect will be mild. It will be 
detected within an hour of placing the block. If this side effect happens you and your 
nurse will be informed to avoid moving out of your bed without assistance until a 
physicianclears you. 
• Other extremely rare risks include infection, swelling and/or bruising caused by a small 
amount of bleeding into surrounding tissue at injection siteand persistent neuropathy 
(tingling, numbness, or weakness most likely in your leg or foot), these should be dealt 
with immediately depending on the situation. 
• There is a risk that data we have stored about you could be lost or exposed. If those data 
suggest something serious about your health, it could be misused. For example, it could 
make it harder for you to get or to keep a job or insurance. We believe the chance these 
things will happen is very small, but we cannot make guarantees. All study staff is 
trained to protect your data and we will do everything we can to make sure that your 
information remains protected. 
Will it cost me any money to take part in this research? 
Regardless of which group you are randomized to you or your insurance will NOT have to pay 
for any medications administered or procedures that are done for research purposes only. 
However, you or your insurance will be billed for all routine medical and diagnostic costs that 
are part of the standard of care for treating your condition. This may include the cost of tests, 
procedures, or medicines to manage any side effects. You will be responsible for any 
deductibles, co-payments, or co-insurance payments that your coverage normally requires. 
Will I be given any money or other compensation for being in this study? 
You will not be paid for taking part in this research. 
What happens if I am injured because I took part in this research? 
If you are injured while in the study, seek treatment and contact the study doctor as soon as you 
are able. 


UMMS Template 06.01.18 
ICF Version 3.0 dated 12.30.2020 
Page 7 of 
Approved UMass Medical School IRB Do not sign this form after this date: 4/20/2021 
 
 
The University of Massachusetts Medical School does not provide funds for the treatment of 
research-related injury. If you are injured as a result of your participation in this study, treatment 
will be provided. You or your insurance carrier will be expected to pay the costs of this 
treatment. No additional financial compensation for injury or lost wages is available. 
You do not give up any of your legal rights by signing this form. 
 
What are my responsibilities if I take part in this research? 
If you take part in this research, you will be responsible to: 
• Follow the directions of the study doctor and research staff. 
• Tell your study doctor and staff about all prescriptions, over the counter medications, and 
vitamins or herbal supplements you are taking, and about all of your health issues. 
• Tell your other health care providers that you are in a research study. 
 
What happens if I say yes, but I change my mind later? 
 
Participating in this study is voluntary. You are free to leave the study at any time. There are no 
penalties and you do not lose any benefits to which you are otherwise entitled. Information that 
we have already collected will stay in the study database and cannot be removed in order to 
maintain the integrity of the research. However, you can ask us to destroy any information that 
identifies you so that no one can tell the data belonged to you. Our contact information is below. 
 
Can I be removed from the research without my approval? 
The person in charge of this research study can remove you even if you want to continue. This 
may happen if it is in your best interest or we don’t see good spread of the local anesthetics 
under the ultrasound. 
How will my information be stored and when will it be destroyed? 
We will remove your name and any other information that could directly identify you from your 
data. We will replace this information with a code number. We will create a master list linking 
your code number to your name. We will keep this list separate from your data. 
We will keep paper documents under lock and key. We will keep electronic health information 
and research data on secure computer networks. These computer networks have many levels of 
protection. 
There is no limit on the length of time we will store your data. We will destroy the master list of 
identifiers when the data analysis is completed. 
It is possible that we might use the research data in other future research. We may also share data 
with researchers and companies that are not part of UMMS. In these cases, we will not share 
your name or other information that identifies you directly, and we will not come back to you to 
ask you for your consent. 
 
Who has access to my information? 


UMMS Template 06.01.18 
ICF Version 3.0 dated 12.30.2020 
Page 8 of 
Approved UMass Medical School IRB Do not sign this form after this date: 4/20/2021 
 
 
Signing this document means you allow us, the researchers in this study, and others working 
with us to use some protected health information for this research study. 
In the event you die while enrolled in the study, all medical records related to your treatment and 
death at any healthcare facility will be released to Eman Nada, MD, and their research staff. 
Your health information and research records will be shared with the study team and with 
individuals that conduct or watch over this research, in order to conduct the study to make sure it 
is conducted as described in this form. Information and records may be sharted with: 
• Federal and state government agencies 
• The University of Massachusetts Medical School and UMass Memorial Medical Center, 
including the Institutional Review Board (IRB) and research, billing, and compliance 
offices 
As part of the research, UMass Memorial Medical Center or any other healthcare facility where 
you are treated may disclose the following information: 
• Demographic and identifying information like your name, date of birth, address, 
telephone number, and your email address 
• Related medical information like family medical history, current and past medications or 
therapies 
• Information from physical examinations, such as blood pressure reading, heart rate, 
temperature, height/weight, and lab results 
• All tests and procedures that will be done in the study 
We will protect your identifiable information from disclosure to others to the extent required by 
law, but we cannot promise complete secrecy. 
Your medical record will contain a copy of this form. Other doctors, nurses, and third parties 
(like insurance companies) may be able to see this information as part of the regular treatment, 
payment, and health care operations of the hospital. We may also need to disclose information if 
required by law. 
We are legally required to disclose information about child abuse, abuse of the elderly or 
disabled, you potentially harming yourself or others, and certain reportable diseases. 
Monitors, auditors, the Institutional Review Boards, and regulatory authorities will be granted 
direct access to your original medical records for verification of clinical trial procedures and 
data. These individuals have been trained to protect confidentiality. 
Any disclosure carries the potential for re-disclosure. Once your protected health information is 
disclosed, it may no longer be protected by federal privacy laws. 
Your authorization does not have an expiration date. If you change your mind, you have the right 
to revoke your authorization in writing or using the contact information at the beginning of this 
form. In such a case, you will not be allowed to continue to participate in the study. We will not 
collect any new information and may only use the information already collected for this research 
study. Your information may still be used and disclosed if you have an adverse event. 
You do not have to sign this authorization. If you choose not to sign, it will not affect your 
treatment, payment, or enrollment in any health plans, or affect your eligibility for benefits. You 
will not be allowed to participate in the research study. 


UMMS Template 06.01.18 
ICF Version 3.0 dated 12.30.2020 
Page 9 of 
Approved UMass Medical School IRB Do not sign this form after this date: 4/20/2021 
 
 
We may publish the results of this research. However, we will keep your name and other 
identifying information confidential. 
Will you share any results with me? 
It may be several years before the results of the research are available. If you would like us to try 
to reach you at that time, please let us know. We will ask for your contact information. 
We can share your individual results with you if you ask. However, because these are research 
tests, they are for your interest only. They cannot tell you about your health or diagnose any 
condition. They will be available when the study data is completely analyzed. 
Who can I talk to? 
If you have questions, concerns, or complaints, or think this research has hurt you or made you 
sick, talk to the research team at the phone number listed on the first page. 
This research is being overseen by an Institutional Review Board. An IRB is a group of people 
who perform independent review of research studies. You may talk to them at (508) 856-4261 or 
irb@umassmed.edu for any of the following: 
• Your questions, concerns, or complaints are not being answered by the research team. 
• You cannot reach the research team. 
• You want to talk to someone besides the research team. 
• You have questions about your rights as a research participant. 
• You want to get information or provide input about this research. 


UMMS Template 06.01.18 
ICF Version 3.0 dated 12.30.2020 
Page 10 of 
Approved UMass Medical School IRB Do not sign this form after this date: 4/20/2021 
 
 
 
 
Signature Block for Capable Adults 
 
Your signature documents your consent to take part in this research. 
 
 
 
 
 
 
Signature of adult research participant 
Date 
 
 
 
 
 
Printed name of adult research participant 
 
 
 
 
 
 
Signature of person obtaining consent 
Date 
 
 
 
 
 
Printed name of person obtaining consent 

Prot_SAP_000.pdf: 
 INVESTIGATOR STUDY PLAN - REQUIRED 
 C  OMPARISON  OF  Q  UADRATUS  L  UMBORUM  B  LOCKS  WITH  M  EDICAL  M  ANAGEMENT 
 FOR  P  AIN  C  ONTROL  AFTER  L  UMBAR  S  PINE  F  USION  S  URGERY 
 NCT04588389 
 S  EPTEMBER  17, 2018 
 Version 1.0 dated 9.17.18 
 Page  1  of  14 
 Template Revised 12/8/2015 


 INVESTIGATOR STUDY PLAN - REQUIRED 
 1. T  ITLE 
 Comparison of Quadratus Lumborum Block with Medical Management for Pain Control after 
 Lumbar Spine Fusion Surgery 
 2. E  XTERNAL  IRB R  EVIEW  H  ISTORY * 
 “NA.” 
 3. P  RIOR  A  PPROVALS : 
 Departmental provisional approval.  The Chair of Orthopedics has approved the project and we 
 will only enroll subjects of the sub investigators listed on the project. 
 Conflict of Interest (COI): 
 No Conflict of Interest. 
 4. O  BJECTIVES * 
 The objective of the study is to compare the opioid sparing effect and the quality of analgesia of quadratus 
 lumborum plane block types 2 and 3 to systemic pharmacological management for postoperative pain 
 control after lumbar spinal fusion. 
 Hypothesis: 
 Quadratus Lumborum plane block, when added to multimodal pharmacological management, will result 
 in a reduced amount of opioids used postoperatively and better postoperative pain control than systemic 
 pharmacological treatment alone. 
 5. B  ACKGROUND * 
 Patients undergoing spinal fusion surgery experience severe postoperative pain.[1] Inadequate 
 pain control increases their morbidity and the development of complications. It also delays 
 postoperative mobilization, rehabilitation and overall patient satisfaction with their perioperative 
 experience.[2]  The problem is compounded in opioid tolerant patients who need double or triple 
 the amount of opioids needed to control the pain compared to the opioid naïve patients.  [3, 4] 
 The excessive use of opioids for postoperative pain management is one of the causes of the 
 current opioid epidemic. Finding ways that can potentially reduce opioid consumption would be 
 a valuable step in curbing this problem. Regional anesthesia using local anesthetics block the 
 pain transmission from the injured site to the brain. It can provide excellent analgesia and help 
 reduce systemic opioid consumption  thereby reducing side effects. [5] 
 Lumbar spine innervation comes from thoracolumbar nerves originating from the spinal cord. 
 The spine is divided anatomically into ventral, lateral and dorsal compartments in relation to 
 intervertebral foramina. The ventral and the lateral compartments are supplied by the lumbar 
 ventral rami of the spinal nerves and the lumbar plexus. The dorsal compartment is innervated 
 by branches of the dorsal rami of the spinal nerves.[6] 
 Version 1.0 dated 9.17.18 
 Page  2  of  14 
 Template Revised 12/8/2015 


 INVESTIGATOR STUDY PLAN - REQUIRED 
 Treating postoperative pain from spinal fusion postoperative at UMMC  is similar to other 
 facilities that perform this procedure. The most commonly used treatment is multimodal 
 medical management. The multimodal medical management uses opioid and non opioid 
 medications, orally or intravenously. Opioids constitute the main componenet of treatment  due 
 to  the severity of the pain and ceiling effect of the other non opioid medications. Finding a 
 pain management  method that can reduce the needed doses of opioids and improve the quality 
 of  pain relief is important.  Case reports of using the quadratus lumborum block for pain relief 
 after spinal surgery have shown promising results [10]. 
 The Quadratum Lumborum Block (QL) is a fascial plane block that is successfully used for 
 treating postoperative pain for abdominal wall surgery. Local anesthetics are deposited between 
 the QL muscle and the plane formed by the thoracolumbar fascia (TLF). Currently, there are 
 three types of the QL block. In the QL1 block, where the local anesthetic medications are 
 deposited anteriorly on the lateral edge of the QL muscle. In QL 2 blocks they are deposited in 
 the plane of the middle TLF posterior to the muscle. In the QL 3, they are deposited on the 
 anteromedial aspect of the QL muscle and behind the psoas major muscle in the plane created 
 by the anterior TLF. 
 Version 1.0 dated 9.17.18 
 Page  3  of  14 
 Template Revised 12/8/2015 


 INVESTIGATOR STUDY PLAN - REQUIRED 
 The numbers on the arrows point to the type of block, 1 = QL1, 2= QL 2, 3= QL 3 Block 
 Red is QL 2, Blue is the QL3 
 It is thought that this nerve block works by local interruption of the impulse transmission as the 
 nerves traverse the plane and also, by backtracking of the medication to the intervertebral 
 foramina. Contrast studies of QL injections show that the contrast reaches the lower thoracic 
 and upper lumbar nerve roots.  For that reason,  It is hypothesized that the QL block works as a 
 paravertebral nerve block[7].  The QL 1 block does not seem to be beneficial in spine surgery 
 as the local anesthetics spreads anteriorly towards the abdomen and therefore not be included in 
 this study. [7, 8]   It is plausible that performing either a QL 2 or QL 3 block would result in 
 good pain relief by blocking the nerve roots and by the direct relaxation of the muscles that are 
 supplied by those nerves. The other values of the QL-block are the simplicity, and the absence 
 of major blood vessels in the area as well as the ability to perform it without interference with 
 the surgical site. 
 6. I  NCLUSION  C  RITERIA : 
 ⮚  Adult Patients undergoing lumbar spinal fusion surgery. 
 ⮚  Patients from 40-70 years. 
 Exclusion Criteria: 
 ⮚  Recent drug abuse 
 ⮚  History of illicit drug use 
 ⮚  Chronic pain patients not related to the back lesions. 
 ⮚  Opioid tolerant patients. 
 ⮚  Patients with any lower extremity weaknesses or deficits. 
 ⮚  Patients with ASA classification more than 3. 
 ⮚  Coagulopathy. 
 ⮚  Infection near or in the area of the block. 
 ⮚  Pregnant patients. 
 Version 1.0 dated 9.17.18 
 Page  4  of  14 
 Template Revised 12/8/2015 


 INVESTIGATOR STUDY PLAN - REQUIRED 
 ⮚  Uncooperative patients who refuse care which directly effects research participation or 
 clinical care. 
 ⮚  If the surgeon reports performing non-typical fusion, 
 ⮚  The presence of intraoperative complications like nerve injury or abnormal results of 
 neuromonitoring and extensive dissection. 
 ⮚  Vulnerable populations (prisoner, mental impairment / dementia, pregnant, etc.) 
 ⮚  Subjects on chronic buprenorphine therapy (either for opioid replacement or pain control) 
 7.  S  TUDY -W  IDE  N  UMBER  OF  S  UBJECTS * 
 This study is a pilot study as part of planning for a larger randomized controlled trial. We plan to 
 enroll a total of 30 patients, with 10 patients randomly assigned in each group of the study. 
 Group I will receive multimodal pharmacological management (control group). Group II will 
 receive the QL II Block and group III will receive the QL III block in combination with 
 multimodal pharmacological Management. [9, 10] 
 8.  S  TUDY -W  IDE  R  ECRUITMENT  M  ETHODS * 
 After coordination with the orthopedic surgeons from the spine division, patients scheduled for 
 an elective lumbar spinal fusion will be identified and screened on the electronic charts by the 
 investigators. Patients who meet the inclusion criteria will be approached and provided with all 
 the study information in the presurgical evaluation (PSE), the spine surgery clinics, or the 
 hospital floor. Patients who agree will be asked to sign the informed consent. For those who need 
 more time to think or could not be reached physically but expressed interest to the surgeon, a 
 study team member will be contacted them by phone and provide all the information and the 
 patient will sign the informed consent on the day of surgery. The study will start as soon as the 
 IRB approves the protocol. The location of the study will be at the UMass Memorial Medical 
 Center, Memorial campus. 
 9. S  TUDY  T  IMELINES * 
 Patients are expected to participate in the study for the first 48 hours after surgery and the first 
 postoperative visit about 2 weeks from the time of surgery. The primary analyses are expected to 
 be completed 6 months after conclusion of the study.  This is intended to be a pilot study; we estimate 
 it to be completed 18 months from the IRB approval date. 
 10. S  TUDY  E  NDPOINTS * 
 Primary Outcome: 
 ●  Fifteen percent drop in MME dose of the opioids consumed at 12, 24, 36 and 48 hours. 
 Secondary Outcome: 
 ●  The NRS every six hours 0, 1, 6, 12, 18, 24, 30, 36, 42 and 48 recorded by nurses in the 
 EPIC flow sheet will be used to collect the data at the approximate time intervals. 
 ●  The amount of left-over opioid pills at 2 weeks in the follow up visit. 
 ●  The presence of any side effects will be reported. 
 Version 1.0 dated 9.17.18 
 Page  5  of  14 
 Template Revised 12/8/2015 


 INVESTIGATOR STUDY PLAN - REQUIRED 
 o  Nausea and vomiting 
 o  Sedation. 
 o  Motor weakness. 
 o  Excessive numbness or paraesthesia. 
 ●  Other side effects. 
 11. P  ROCEDURES  I  NVOLVED * 
 ●  After coordinating with the orthopedic surgeons from the spine division, potential 
 candidates will be contacted (in the clinics or the floor as above) and the study will be 
 thoroughly explained to them by the research staff, PI or sub investigators. 
 ●  Informed consent will be obtained from the patients who are willing to participate. 
 ●  All study patients will be randomized to receive either multimodal pharmacological 
 management only or with one of the 2 blocks- QL 2 block or QL 3 - using a sealed 
 envelope. 
 ●  The  study  patients  will  be  revaluated  before  surgery  and  their  consent  will  be 
 confirmed. 
 ●  Anesthesia  is  a  standard  general  anesthesia  where  opioids  will  be  used  based  on  the 
 discretion of the anesthesia provider. 
 ●  After their surgery is completed and the leg movement is tested, the patients will receive 
 the block in the operating room or in the post anesthesia care unit (PACU), their pain will 
 be evaluated and documented by the nurse caring for the patient. 
 ●  For  the  blinding  purposes,  the  patients  will  be  told  that  there  are  two  possible  sites  at 
 which  they  will  receive  the  block.  The  sites  will  be  either  in  the  operating  room  before 
 you  wake  up  from  anesthesia  or  in  the  PACU.  The  patients  on  the  medical  management 
 group  will  be  told  that  they  have  received  their  block  before  recovering  from 
 anesthesia,  the  PACU  nurse  will  be  told  the  same  as  well  to  make  him  or  her  blinded  as 
 a pain assessor. 
 ●  For  those  who  will  have  the  block,  the  procedure  will  be  as  follows:  the  hip  will  be 
 raised  on  the  side  of  the  block  and  the  area  between  the  iliac  crest  and  costal  margin  is 
 scrubbed  using  chlorhexidine  solution.  Under  complete  aseptic  technique  including  a 
 sterile  ultrasound  probe  sleeve  and  ultrasound  guidance,  20  ml  of  ropivacaine  0.25  % 
 will  be  injected  in  the  facial  planes  as  decided  by  the  randomization  envelope.  The 
 procedure will be repeated on the other side. 
 ●  The  patient’s  vital  signs  will  be  recorded  every  5  minutes  for  30  minutes  after  the 
 procedure. 
 ●  The  pain  score  will  be  recorded,  and  the  patient  will  be  examined  for  signs  of  sensory 
 and motor blockade after 1 h using the following score: 
 Muscle strength using the Medical Research Council (MRC Scale)[11] 
 0= Complete Paralysis 
 1=Minimal Contraction. 
 2=Active movement with gravity eliminated. 
 3=Weak contractions against gravity. 
 4= Active movement against gravity 
 5= Normal strength. 
 Version 1.0 dated 9.17.18 
 Page  6  of  14 
 Template Revised 12/8/2015 


 INVESTIGATOR STUDY PLAN - REQUIRED 
 The dermatomes will be tested for sensory blockade 
 using ice. See Figure 1. 
 Figure 1: Dermatomes of interest 
 Table I: Motor Blockade 
 R 
 L 
 Group of Muscles 
 MRC Muscle Strength 
 0 
 1 
 2 
 3 
 4 
 5 
 L2 
 Hip Flexors 
 L3 
 Knee Flexors 
 L4 
 Ankle Dorsiﬂexes 
 L5 
 Long toe Extensors 
 S1 
 Ankle plantar ﬂexors 
 All the patients will receive a multimodal pharmacological management comprised of the 
 following medications: 
 ●  Oral acetaminophen, intravenous Ketorolac (Toradol) and Gabapentin. 
 ●  Opioids: 
 ⮚  Oxycodone q 4 hours as needed based on the patient's pain 
 Version 1.0 dated 9.17.18 
 Page  7  of  14 
 Template Revised 12/8/2015 


 INVESTIGATOR STUDY PLAN - REQUIRED 
 Patients with pain 3-4 on NRS will receive 5 mg; pain from 5-7, they will receive 
 10 mg; pain from 8-10 they will receive 15 mg. 
 ⮚  As needed PRN intravenous hydromorphone 0.2 mg q 2hs. 
 12. D  ATA  AND  S  PECIMEN  B  ANKING * : 
 “NA” 
 13. Data Analysis and Management*: 
 The primary analysis of interest is the comparison of the reduction in morphine milligram 
 equivalent (MME) dose of opioids consumed between the multimodal pharmacological 
 management (control group) versus nerve block (QL II and QL III) groups. Specifically, we 
 hypothesize that people receiving a nerve block will have less opioid consumption per day for 48 
 hours than people receiving standard-of-care.  To answer this question, we will use a two-sample 
 t-test of means with unequal n’s comparing MME between the two groups (control vs nerve 
 block (QLII & QLIII)).  Although not directly powered to do so we will also determine if a 
 difference exists in MME doses between the two nerve block groups (QLII & QLIII) using a 
 similar approach as described above. 
 As a secondary outcome we will also utilize the Numeric Rating Scale for pain scores to be 
 measured every six hours for 48 hours (8 measurements).  We will compare pain scores between 
 control vs. nerve block groups using a repeated measures ANOVA model. We will also repeat 
 these analyses looking for a difference between all three groups. 
 Allocation of participants to study arms will be based on a permuted block scheme in which 
 treatment assignments are made within blocks so that numbers assigned to each treatment arm 
 are equal after a block has been filled.  Blocks of various sizes will be used in random order to 
 facilitate allocation concealment.  The randomization process will be facilitated using a prime 
 modulus multiplicative pseudo-random generator. 
 Secondary Outcome: 
 ●  The VRS every six hours 0, 1, 6, 12, 18, 24, 30, 36, 42 and 48 recorded by nurses in the EPIC 
 flow sheet will be used to collect the data at the approximate time intervals. 
 ●  The amount of left-over opioid pills at 2 weeks follow up visit. 
 ●  The presence of side effects will be reported. 
 o 
 Nausea and vomiting 
 o 
 Sedation: using Pasero Opioid-induced Sedation Scale (POSS) 
 ▪ 
 1 = Awake and alert 
 ▪ 
 2 = slightly drowsy, easily aroused Acceptable. 
 ▪ 
 3 = frequently drowsy, arousable, drifts off to sleep during the conversation. 
 ▪ 
 4 = Somnolent, minimal or no response to verbal and physical stimulation 
 o 
 Motor weakness. 
 o  Excessive numbness or paraesthesia 
 ●  Other side effects . 
 Version 1.0 dated 9.17.18 
 Page  8  of  14 
 Template Revised 12/8/2015 


 INVESTIGATOR STUDY PLAN - REQUIRED 
 14. P  ROVISIONS  TO  M  ONITOR  THE  D  ATA  TO  E  NSURE  THE  S  AFETY  OF  S  UBJECTS * 
 The principal investigator will be responsible to review the data periodically to assess the 
 outcome of the study. Severe complications related to the block like deep-seated infection, 
 hematoma formation that needs surgical intervention or irreversible leg weakness or nerve 
 damage will be reported immediately and may trigger suspension of research. 
 15. W  ITHDRAWAL  OF  S  UBJECTS  W  ITHOUT  T  HEIR  C  ONSENT * 
 “NA” 
 16. R  ISKS  TO  S  UBJECTS * 
 Patients might feel some discomfort on the introduction of the needle to place the block; 
 however, local anesthetic infiltration of the skin will be used to minimize this discomfort. Other 
 side effects are rare but can be in the form of a mild temporary leg weakness. The motor strength 
 of the lower extremities will be checked within the first one hour after the block. If leg weakness 
 does not happen in the first hour then it will not happen. During this period the patient will be in 
 the recovery room and under continuous monitoring 
 While rarely reported, if leg weakness should happen it will be mild and temporary due to the 
 low concentration of the local anesthetic, and the type of the local anesthetic we use. 
 Ropivacaine has preferential sensory blockade rather than motor blockade. We also will be using 
 the dilute form which is 0.25% of Ropivacaine and is known to have minimal motor blocking 
 properties if at all[12, 13].  As stated above, the motor strength of the lower extremities will be 
 checked one hour after the block, which will be sufficient time to show this potential side effect. 
 If it occurs it will present within the first hour after the block while the patient is in the recovery 
 room and under continuous monitoring.  Patients and the floor nurse will be made aware that that 
 patient should not move out of bed in absence of personal assistance. One of the investigators 
 will follow up with the patient until the weakness resolves. Other possible extremely rare risks 
 include infection, hematoma and persistent neuropathy. The patients will be examined every day 
 during their hospital stay.   After discharge the patients  will be able to contact the primary spine 
 surgery service that will notify the PI.   All the necessary intervention will be done as the case 
 dictates. 
 17. P  OTENTIAL  D  IRECT  B  ENEFITS  TO  S  UBJECTS * 
 The potential benefits to the patients are: 
 ●  Better pain relief following a significantly painful surgery. 
 ●  Reduced opioid use. 
 ●  Earlier participation in rehabilitation, faster recovery and hospital discharge. 
 18. V  ULNERABLE  P  OPULATIONS * 
 The study does not intend to include any vulnerable patients. 
 Version 1.0 dated 9.17.18 
 Page  9  of  14 
 Template Revised 12/8/2015 


 INVESTIGATOR STUDY PLAN - REQUIRED 
 19. M  ULTI -S  ITE  R  ESEARCH * 
 “NA” 
 20. C  OMMUNITY -B  ASED  P  ARTICIPATORY  R  ESEARCH * 
 “NA” 
 21. S  HARING  OF  R  ESEARCH  R  ESULTS  WITH  S  UBJECTS * 
 Upon conclusion of the study, patients can contact the study PI for the results of the study. 
 22. S  ETTING : 
 The study will take place locally at the UMASS Memorial Medical Center, Memorial campus. 
 Explanation of the study will take place in the PSE, spine clinic, the hospital floors, by the phone 
 and /or the in the preoperative holding area.  Nerve block procedures will be performed in the 
 post anesthesia care unit (PACU) after surgery is completed. The follow up will happen on the 
 hospital floor. 
 The data will be accessed and stored safely on a secured server. 
 23. R  ESOURCES  A  VAILABLE : 
 Specific anesthesiologists specialized in regional anesthesia will administer the nerve blocks for 
 all subjects involved in this study. 
 Roles 
 PI : The PI will plan the study, oversee the whole  process, perform some of the blocks, receive 
 the results, interpret the results after the statistical analysis is done and write the manuscript. The 
 PI is an anesthesiologist who is trained in the subspecialty of regional anesthesia. 
 Sub investigators:  Assist in the study planning, performing  the blocks, following the study and 
 writing the manuscript.  The co-investigators are anesthesiologists who are trained in the 
 subspecialty of regional anesthesia and orthopedic surgeons who operate on the patients. 
 Research coordinators/Nurse:  Will assist in formulating  the study plan, randomizing, 
 explaining the study to potential participants, and collection of data. The research coordinators 
 are nurses or research coordinators who are experienced in conducting research. 
 24. L  OCAL  R  ECRUITMENT  M  ETHODS 
 As a pilot study, we will plan to do 10 cases in each group. Patients will be screened for 
 eligibility based on the inclusion criteria and exclusion criteria, adult patients undergoing 2 or 
 more levels of lumbar fusion, with no chronic pain issues other than back pain. The patient’s 
 medical record number will be the identifier used to screen the patient records. Patients who 
 agree to participate will be evaluated and consented. Patients who turn out to be ineligible to 
 Version 1.0 dated 9.17.18 
 Page  10  of  14 
 Template Revised 12/8/2015 


 INVESTIGATOR STUDY PLAN - REQUIRED 
 participate after the initial consent will be informed of the reason. After the patient who enter the 
 study, will be given a study code and their data will be saved under that code and no identifier 
 will be linked to the data. 
 25. L  OCAL  N  UMBER  OF  S  UBJECTS :  We plan to enroll 30  subjects. 
 26. C  ONFIDENTIALITY 
 Data of each study patient will be collected by study members and entered in a spreadsheet. Each 
 coauthor will hand the data of the cases they do to the PI and the research coordinators. Only the 
 PI and the research coordinators will have access to all the data. The data will be stored in a 
 secure server location assigned to the study. Each patient data will be entered under a code 
 assigned to them. 
 The data that will be stored is the study patients are the following: 
 ⮚  Age 
 ⮚  Gender. 
 ⮚  Details of the surgical procedure: anterior/ lateral level and number of fusion, number of 
 levels fused. 
 ⮚  Type, dose of opioids used preoperatively and their MME doses. 
 ⮚  Type, dose of opioids used intraoperatively and their MME doses. 
 ⮚  Type and total MME doses every 12, 24, 36 and 48. 
 ⮚  Types and doses of non-opioids analgesics and adjuvants (e.g. Acetaminophen, 
 non-steroidal anti-inflammatory drugs, gabapentin, clonidine. 
 ⮚  Side Effects: 
 ●  Muscle weakness. 
 ●  Excessive numbness. 
 ●  Other side effects. 
 Storage:  The source data will be stored in the critical  care research office. The Critical Care 
 Research office is secured with a keypad lock. The combination is known only to authorized 
 individuals. The electronic data will be kept on UMASS secure servers and protected in a 
 database that is password protected and encrypted. Data will be stored in the password protected 
 secure files. 
 Each study patient data will be de-identified and given an ID number and all their data will be 
 saved under that ID. 
 Data:  All data will be transmitted to the PI and  the research coordinators who will store the data 
 on a secure server.  Data will be tabulated in excel tables. Descriptive statistics will be used 
 describe data. Comparison of data will be done using two-way ANOVA 
 Version 1.0 dated 9.17.18 
 Page  11  of  14 
 Template Revised 12/8/2015 


 INVESTIGATOR STUDY PLAN - REQUIRED 
 27. P  ROVISIONS  TO  P  ROTECT  THE  P  RIVACY  I  NTERESTS  OF  S  UBJECTS 
 A HIPAA waiver of authorization will be used to screen any subjects after the surgeons send the 
 patient names as appropriate candidates for this research study. The subjects will be made 
 comfortable and given enough privacy during and after all the steps of the research. Drapes and 
 curtains will be used during the procedure, local anesthetic medication will be used to infiltrate 
 the target pathway. Patient will be informed that they have the right to skip any question they 
 don’t wish to answer. 
 Only research personnel involved in the research study and trained to conduct the study related 
 procedures will be involved with the subjects. 
 28. C  OMPENSATION  FOR  R  ESEARCH -R  ELATED  I  NJURY 
 Neither subjects nor their insurance will be billed for research procedures.  The University of 
 Massachusetts Medical School does not provide funds for the treatment of research-related 
 injury. However, if the subject is injured as a result of their participation in this study, treatment 
 will be provided. The subject or their insurance carrier will be expected to pay the costs of this 
 treatment. No additional financial compensation for injury or lost wages is available. 
 29. E  CONOMIC  B  URDEN  TO  S  UBJECTS 
 Subjects will not incur any cost from being in the study.  All study related charges will be paid 
 internally through the department, as per the charges generated by Investigational Drug Services 
 (IDS). 
 30. C  ONSENT  P  ROCESS : 
 Where will the consent process take place:  The consent  process will take place in the 
 presurgical evaluation (PSE), the spine surgery clinics, or the hospital floor. 
 Any waiting period available between informing the prospective subject and obtaining 
 consent:  The subject will be given as much time as  possible to decide whether they would like to 
 participate in the research study. All questions will be discussed. If the subject is not comfortable 
 making a decision, the subject will not be enrolled. 
 Informed Consent Process:  The principal investigator  will ensure that informed consent is 
 obtained in accordance with the SOP: HRP-802 INVESTIGATOR GUIDANCE: Informed 
 Consent”. Those obtaining informed consent from the subject will be a PI, sub investigator, 
 research nurse, research nurse manager or research coordinator who has been properly trained by 
 the principal investigator, is knowledgeable about the study and able to answer any questions the 
 potential subject may ask. 
 Version 1.0 dated 9.17.18 
 Page  12  of  14 
 Template Revised 12/8/2015 


 INVESTIGATOR STUDY PLAN - REQUIRED 
 After discussing the study in detail (risks, procedures, follow-up) the subject will be given the 
 informed consent form to review. The subject will be asked if they understand what has been 
 explained. All questions will be discussed. If they are uncomfortable or hesitant about 
 participating in the research, the consent process will be stopped. If the subject is willing to 
 participate in the research, they will sign and date the informed consent form. The research staff 
 personnel obtaining consent will sign and date the forms where appropriate. A copy of the ICF 
 form will be given to the subject. The original ICF will be placed in the regulatory binder for the 
 research study. A copy of the ICF form will be placed in the subject’s medical record. 
 A note will be placed in the subject’s electronic medical record noting the following: 
 • The date and time that the informed consent form was signed 
 • Discussion of the study and questions answered 
 • That the subject met all study entry criteria 
 31. T  HE  PROCESS  TO  D  OCUMENT  C  ONSENT  IN  W  RITING 
 We will be following the “HRP-803 INVESTIGATOR GUIDANCE: Documentation of 
 Consent.” 
 32. D  RUGS  OR  D  EVICES : 
 The drug that is going to be used in the study is Ropivacaine 0.25% diluted in saline to 0.2 %. 
 The ultrasound machine will be used to guide the block. The study medication will be 
 administered by a licensed professional who is appropriately knowledgeable in the 
 administration of the study drug. All study drugs have been coordinated with Investigational 
 Drug Services. 
 References: 
 1 . 
 Bajwa, S.J. and R. Haldar,  Pain management following  spinal surgeries: An appraisal of 
 the available options.  J Craniovertebr Junction Spine,  2015. 6(3): p. 105-10. 
 2. 
 Wainwright, T.W., T. Immins, and R.G. Middleton,  Enhanced recovery after surgery 
 (ERAS) and its applicability for major spine surgery.  Best Pract Res Clin Anaesthesiol, 
 2016. 30(1): p. 91-102. 
 3. 
 Rapp, S.E., L.B. Ready, and M.L. Nessly,  Acute  pain management in patients with prior 
 opioid consumption: a case-controlled retrospective review.  Pain, 1995. 61(2): p. 
 195-201. 
 4. 
 Mitra, S. and R.S. Sinatra,  Perioperative management  of acute pain in the 
 opioid-dependent patient.  Anesthesiology, 2004. 101(1):  p. 212-27. 
 5. 
 Souzdalnitski, D., T.M. Halaszynski, and G. Faclier,  Regional anesthesia and co-existing 
 chronic pain.  Curr Opin Anaesthesiol, 2010. 23(5):  p. 662-70. 
 6. 
 Bogduk, N.,  The innervation of the lumbar spine.  Spine (Phila Pa 1976), 1983. 8(3): p. 
 286-93. 
 Version 1.0 dated 9.17.18 
 Page  13  of  14 
 Template Revised 12/8/2015 


 INVESTIGATOR STUDY PLAN - REQUIRED 
 7. 
 Carline, L., G.A. McLeod, and C. Lamb,  A cadaver study comparing spread of dye and 
 nerve involvement after three different quadratus lumborum blocks.  Br J Anaesth, 2016. 
 117(3): p. 387-94. 
 8. 
 Børglum J, et al.  Ultrasound-Guided Transmuscular  Quadratus Lumborum Blockade . 
 BJA, 2013. 
 9. 
 Bell, M.L., A.L. Whitehead, and S.A. Julious,  Guidance  for using pilot studies to inform 
 the design of intervention trials with continuous outcomes.  Clin Epidemiol, 2018. 10: p. 
 153-157. 
 10. 
 Lancaster, G.A., S. Dodd, and P.R. Williamson,  Design and analysis of pilot studies: 
 recommendations for good practice.  J Eval Clin Pract,  2004. 10(2): p. 307-12. 
 11. 
 Paternostro-Sluga, T., et al.,  Reliability and  validity of the Medical Research Council 
 (MRC) scale and a modified scale for testing muscle strength in patients with radial 
 palsy.  J Rehabil Med, 2008. 40(8): p. 665-71. 
 12. 
 Lacassie, H.J., et al.,  Motor blocking minimum  local anesthetic concentrations of 
 bupivacaine, levobupivacaine, and ropivacaine in labor.  Reg Anesth Pain Med, 2007. 
 32(4): p. 323-9. 
 13. 
 Lacassie, H.J., et al.,  The relative motor blocking  potencies of epidural bupivacaine and 
 ropivacaine in labor.  Anesth Analg, 2002. 95(1): p.  204-8, table of contents. 
 Version 1.0 dated 9.17.18 
 Page  14  of  14 
 Template Revised 12/8/2015