Clinical trial NCT03758261
Conditions: Thoracic Surgical Procedures
Keywords: VATS Regional Anesthesia Paravertebral nerve block Erector Spinae nerve block Video assisted thoracoscopic surgery
Sponsor: Charles Luke
Start date: 2019-03-11; Completion date: 2020-06-25
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Continuous paravertebral analgesia and erector spinae plane blockade (ESP) are accepted techniques at University of Pittsburgh Medical Center (UPMC) for the management of thoracic pain following surgery and trauma. Recently, an increasing number of erector spinae plane nerve blocks are being performed as it has been demonstrated in our institution, and via case reports that the blocks provide clinical effectiveness, but may have a better side-effect profile than the paravertebral nerve block. However, the relative efficacy of ESP compared to paravertebral nerve block remains to be established for video assisted thoracoscopic surgery (VATS). This is a prospective randomized study intended to assess the efficacy, safety and side-effect profile of continuous erector spinae plane analgesia versus continuous paravertebral analgesia for VATS procedures. It will include 60 patients presenting to UPMC Passavant for a VATS procedure. Patients will be randomized 1:1 to receive either a nerve block via continuous paravertebral infusion or via erector spinae plane infusion. In addition, to treat breakthrough pain, the patients in both arms will receive multimodal adjunctive therapy per routine. Bupivacaine and ropivacaine are FDA approved for use in nerve block catheters. The primary outcome will be to compare analgesic efficacy between the two nerve blocks as defined by total opioid consumption and pain scores on the numeric pain rating scale. Secondary outcomes include incentive spirometer amounts (baseline vs daily score postoperatively), length of stay, duration of catheter and report of adverse events or complications. Other data points include number of chest tubes and location and level of catheter and nerve block placement as well as number of blocks per case.

Detailed description:
Background and significance:

Multimodal analgesia for thoracic surgery is key to allow faster recovery and diminish postoperative complications. Paravertebral nerve blocks as well as epidurals are among the regional anesthetic techniques utilized for these procedures. Recently, a newer technique, the erector spinae plane block, has been used and described to be effective in treating pain for patients undergoing thoracic surgery. At UPMC, the investigators have had clinically significant pain control for thoracic surgery with both types of blocks. The previous case reports/series and our clinical observation has led us to propose this study of comparing the clinical efficacy of erector spinae plane block vs. paravertebral nerve block.

Though ESP and paravertebral blocks have been documented to be efficacious for this procedure, there has been no direct comparison between the two approaches. The ESP block is considered to be a safer technique with less theoretical adverse events possible and thus, would become a viable alternative to the more technically challenging paravertebral nerve block. If ESP is found to be superior or non-inferior to paravertebral in terms of pain management and safety, this would be a major finding, as ESP is considered safer and technically easier to perform than paravertebral nerve block.

Study design and methods

The investigators present a prospective randomized trial comparing the efficacy of continuous paravertebral nerve blocks vs. ESP blocks for video assisted thoracoscopy surgery (VATS) at UPMC Passavant.

Arms: arm 1: Erector Spinae nerve block arm 2: Paravertebral nerve block
Interventions: intervention 1: Paravertebral nerve block intervention 2: Erector Spinae nerve block
Intervention descriptions: intervention 1: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed. intervention 2: The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.

Protocol documents:
ICF_002.pdf: 
 
 
 
 
Department of Anesthesiology 
 
CONSENT TO ACT AS A PARTICIPANT IN A RESEARCH STUDY TITLE: 
ESP vs. PVB Nerve Blocks for Video Assisted Thoracoscopic Surgery (VATS) 
 
PRINCIPAL INVESTIGATOR: 
 
Shah Neal, MD 
 
Department of Anesthesiology 
200 Lothrop Street 
Pittsburgh, Pennsylvania 15213 
Passavant Hospital: 412- 367-6700; 
call on weekdays between 7 am – 4 pm 
 
 
 
CO-INVESTIGATORS: 
 
 
 
Maria Hernandez, MD 
 
Nicholas Schott, MD 
Stephanie Nam 
Charles Luke, MD 
Charles Lin, MD 
Touichi Kawabe, MD 
David Glover, MD 
 
SOURCE OF SUPPORT: 
 
UPMC Department of Anesthesiology 
 
 
Why is this research being done? 
 
You are being asked to participate in this research study because you are at least 18 years of 
age and you are scheduled to have a video assisted thoracoscopic surgery. Thoracic surgery 
can cause significant pain, which makes it difficult for you to breath. Nerve blocks are part of 
several ways to manage pain after surgery and by helping you breathe they also help decrease 
complications after the surgery. When we do nerve blocks, we inject local anesthetics (numbing 
medication) around the nerves that give you sensation to site where you had surgery, 
“numbing” the area. 
There are several nerve blocks that we use to achieve pain relief. With this study we are 
comparing 2 techniques that we use routinely to evaluate efficacy and also safety. 
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 study the difference of two similar but different nerve blocks for 
 
 
 
 
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videothoracoscopic surgery. A nerve block is a procedure where we use an ultrasound machine 
to guide a needle so we can place a solution of pain medication around your nerves, so we can 
“numb” the nerves. This causes a numbing sensation in the painful area, thus reducing your 
discomfort and making your more comfortable. Under the current standard of care, multiple 
types of nerve blocks are used including thoracic epidural nerve catheter infusions, 
paravertebral nerve block catheter (PVB) infusion and erector spinae block catheter infusions 
(ESP). PVB and ESP are both nerve block techniques for which ropivacaine and bupivacaine 
are FDA approved for. The hope of this study is to determine if the ESP can provide comparable 
pain relief compared to PVB, while at the same time also decreasing the unwanted side effects 
or risks of other nerve blocks. 
 
While previous studies have demonstrated that the PVB has not been inferior to thoracic 
epidurals for pain relief, no formal studies comparing PVB to ESP have been made. Additional 
pain medications will be available to you if needed, regardless of which group you are assigned 
to. 
 
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. Neal Shah at Passavant Hospital: 412- 367-6700; or call on weekdays 
between 7 am – 4 pm 
Answering Service: 412-692-2333 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 up to 5 days after your nerve 
block. We will be collecting data until 60 patients have been enrolled and fully evaluated. 
 
How many people will be studied? 
 
We anticipate that approximately 60 patients will be included in this research study. All 
patients will be from UPMC Passavant Hospital. 
 
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: 
 
Paravertebral Nerve Block Catheter – This group will receive pain management via 
a paravertebral nerve block catheter. This will include ultrasound guidance. All 
standard multimodal pain medications will be included as well. 
 
 
 
 
 
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Erector Spinae Block Catheter – This group will receive pain management via an 
erector spinae nerve block catheter. This will include ultrasound guidance. All 
standard multimodal pain medications will be included as well. 
 
The procedure for both of the above types of nerve blocks are essentially the same for you. 
Both nerve blocks can take between 10-60 minutes to perform. They will either occur in the 
preoperative holding area or a designated block area or in the operating room. The difference 
between the two types of nerve block is the target, which is within a few centimeters of each 
other. To perform this procedure, we ask you to sit at the edge of your hospital bed. We use a 
marker to mark the spot on your back where the needle will enter your skin. We clean your 
back, and place sterile drapes over the area to protect it from infection. We inject lidocaine 
(numbing medicine) into the skin to make the procedure painless. We then use an ultrasound 
machine to identify the location of the target nerves. We then place a needle into your back in 
the area of the numbing medicine. We use the ultrasound to guide the needle into place. We 
then inject more numbing medicine (ropivacaine) into your back to improve your pain. We then 
thread a very small plastic catheter into your back, and remove our needle. We provide more 
numbing medicine through the plastic catheter. We then tape the catheter to your skin, and lay 
you back in bed. We hook the catheter to a medicine pump, that will continuously deliver more 
numbing medicine (bupivacaine) for the duration of your treatment. After the treatment period, 
we remove the catheter which does not cause any pain. We cover the area with gauze and 
tape, and continue to provide pain medicine with oral and IV medications as needed. 
 
During your treatment with the nerve block catheter, the pain management team adjusts the 
amount of pain medication given through the catheter to promote comfort. Every hour, your 
nurse can give you an extra dose of bupivacaine if needed for pain control. We remove the 
catheters based on how well you tolerate the nerve block in combination with other pain 
medicines, after no more than 5 days. Most catheters remain for approximately 72 hours (3 
days). 
 
Regardless of which group you are assigned to, follow-up assessments will occur: 
 
During the next 3 days after your nerve blocks. You will be followed-up post-
procedure at 15 minutes, 60 minutes; post-procedure day 1 at 9:00AM; post 
procedure day2 at 9:00AM and post-procedure day 3 at 9:00AM. 
 
Items that will be assessed at these time intervals include: 
 
o Your verbalized pain scores from 0-10 at rest and with 
breathing o The amount and types of opioid pain medications you 
require o The time you first request extra opioid medications 
 
o Total local anesthetic utilized 
o Your vital signs 
 
o Presence or absence of complications including pneumothorax, bleeding, 
dislodgment of catheter, needing for re-dressing of catheter, or block site 
infection. 
o Presence or absence of signs of local anesthetic toxicity including perioral 
numbness, ringing in your ears, and/or metallic taste in your mouth 
 
The medications utilized for the PVB and ESP will include ropivacaine and/or bupivicaine. 
Ropivacaine and bupivacaine are FDA approved local anesthetics for nerve block procedures. A 
total of 25mL of 0.5% Ropivacaine will be used with 25mL allocated to the nerve block site. An 
infusion of up to 12 ml/hr of .0625% bupivacaine along with an option 3ml requested bolus will 
be ordered. This is a standard dose for this surgery for nerve block infusions. 
 
 
 
 
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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 rib fractures, and anti-coagulation status. 
 
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 The time you first request extra opioid medications 
Your vital signs 
 
Presence or absence of complications including pneumothorax, bleeding, dislodgment 
of catheter, needing for re-dressing of catheter, or block site infection. 
Presence or absence of signs of local anesthetic toxicity including perioral numbness, 
ringing in your ears, and/or metallic taste in your mouth 
 
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, we will provide alternative means to 
control your pain to the best of our abilities. This may include a nerve block, even if you do not 
want to participate in the study. 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 verbal notification to the study team or the 
principal investigator. Contact information is available on 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: 
 
o 
Access to health information 
o Screening procedures 
 
o Follow-up 
 
 
 
 
 
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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 the Paravertebral Nerve Block (PVB) include: 
 
Bleeding 
Infection 
Damage to surrounding 
structures Pneumothorax 
Epidural spread of medication 
Tenderness at insertion site 
Block failure 
 
Risks associated with the Erector Spinae Plane Block (ESP) include: 
 
Bleeding 
Infection 
Damage to surrounding 
structures Pneumothorax 
Tenderness at insertion 
site Block failure 
 
There is a very low risk of experiencing one or more of the possible side effects above if you are 
in either group assigned. 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 may have some discomfort while having the nerve 
block placed as this utilizes a needle to penetrate the skin and structure until at the correct site. 
Prior treatment to the proposed insertion site with local anesthetic may be used or sedation at 
disclosure of the attending anesthesiologist. 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 ropivacaine/bupivacaine include: 
 
Patient: 
 
o 
Restlessness 
o Anxiety 
 
o Dizziness 
o Tinnitus 
 
o Blurred vision 
o Tremors 
 
o Depression of the myocardium: decreased cardiac output, heart-block, 
hypotension, bradycardia, ventricular arrhythmias 
o Allergic type reactions. 
 
Considering that the medications used in the nerve blocks are continuously flowing, the risks 
displayed above are continuous while the nerve block is in place. The medical staff is trained to 
identify any adverse drug effects and can quickly shut off the nerve block if you experience any 
 
 
 
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side effect. You will also have continuous cardiac and respiratory monitoring while the nerve 
block is in place. The doses used in this study are standard, and have been administered to 
many thousands of patients worldwide. The risks of adverse drug effect are very low. 
 
There may be some inconvenience to you associated with the follow-up that is planned for this 
study. However, this is standard procedure for a; patients receiving nerve blocks under the 
interventional pain service. This a safety measure to ensure adequate treatment and limitation 
of side effects. 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-traumatic pain control, 
decreased need for post-traumatic pain medications, standardized nerve block 
recommendations and decreased incidence of opioid related side effects such as nausea, 
vomiting, pruritus (itching), and sedation. This will help determine which nerve block is safer 
and more appropriate for patients in your situation. 
 
 
 
If I do not want to participate in this study, how will my pain be managed? 
 
If you do not want to participate in the study it will not affect you care. You will have access to 
the standard of care which includes oral, intravenous, and topical pain medications in 
combination with nerve blockade for patients who can tolerate them. It is often best to include 
a nerve block to complete what we call multi-modal analgesia, but it is not always wanted or 
possible. We use medications like opioids, NSAIDS, tylenol, ketamine, gabapentin, lidocaine 
patch, among many others, for pain control. Either the ICU / medical / pain management 
physicians will manage the rib fracture pain with a variety of the above agents to promote 
comfort. 
 
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 
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 surgical plan 
including the need to have a surgery or additional procedures which may alter pain results. 
 
 
 
 
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Are there costs of participating in this study? 
 
For this study, you will not be charged for any additional costs for having enrollment or 
nerve block type other than standard billing procedures per department protocol. You or 
your insurance will be billed for all procedural requirements and all medications required for 
pain management, which is the same for patients who are not enrolled in this study. 
 
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. 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: 
oThe University of Pittsburgh 
 
oThe 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 
 
 
 
 
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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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
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: 
 
 
Neal Shah, M.D. 
 
Department of Anesthesiology 
Universirty of Pittsburgh Medical Center 
200 Lothrop 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. 
 
 
 
 
 
 
 
 
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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 
 
 
 
 
 
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_____________________________ 
 
Printed name of subject 
 
 
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: Randomized Clinical Trial of Erector Spinae Plane (ESP) vs. 
Paravertebral Nerve Blockade for Video Assisted Thoracoscopic Surgery (VATS) 
 
IRB ID: PRO18070064 
 
NCT Number: NCT03758261 
 
STATISTICAL ANALYSIS PLAN – 01/03/2020 
 
 


 
Statistical Analysis Plan  
 
The number of 80 total patients (40 in each arm) is similar to many studies that have 
been adequately powered to detect a clinical difference between nerve blocks. For 
example, Jaegar et al 2013 Volume 38 Issue 6 discovered a significant difference 
between muscle strength in femoral nerve versus adductor canal block with a total of 54 
patients. 80 patients were chosen because we are hoping to achieve a power of 80%. 
Previous studies have identified mean opioid consumption in patients undergoing VATS 
procedure and receiving normal paravertebral nerve blocks is approximately 100mg 
OME. We hope in our experimental group to detect a difference in mean opioid 
consumption (10% or more ideally). Based on our goal power of the study, we would 
need a sample size of 32 patients. After surveying the volume of patients undergoing 
this procedure at our intended site, we deemed that it would be possible to recruit 60 
patients for this study in a reasonable period of time. For parametric data we will use a 
t-test. For non-parametric data we will use a Mann-Whitney U Test. For categorical data 
we will use a chi-square test. We may use a log regression evaluation if needed. We will 
use repeated measures ANOVA test to compare repeated measures for each patient. 
Statistical data will be analyzed using SAS software. 

Prot_003.pdf: 
 
 
 
 
 
 
 
 
 
 
STUDY TITLE: Randomized Clinical Trial of Erector Spinae Plane (ESP) vs. 
Paravertebral Nerve Blockade for Video Assisted Thoracoscopic Surgery (VATS) 
 
IRB ID: PRO18070064 
 
NCT Number: NCT03758261 
 
STUDY PROTOCOL – 08/28/2019 
 
 


ESP vs. PVB Nerve Blocks for Video Assisted Thoracoscopic Surgery (VATS) Research  
Protocol 
Continuous paravertebral analgesia and erector spinae plane blockade (ESP) are accepted 
techniques at UPMC for pain management in thoracic surgery. This is a prospective randomized 
study intended to assess the efficacy, safety and side-effect profile of continuous ESP block Vs 
continuous paravertebral block for VATS procedures.  
Methods:  
Once the patient has agreed to have peripheral nerve blocks as part of the analgesia technique and 
meets inclusion criteria, the patient will be asked to participate in the study. If they agree to 
participate, informed consent will be obtained and we will proceed with randomization.  
Patient selection and Inclusion/Exclusion criteria 
Inclusion criteria: 
* Patients undergoing VATS agreeable to have a nerve block as analgesic technique 
* Age: 18 years old and older. 
* ASA I-IV 
Exclusion criteria: 
* Cognitive impairment that would not allow effective nerve block placement or gathering 
information related to the study (ex. pain score). 
* Contraindications for nerve block placement such as coagulopathy, use of clopidogrel in the past 
48hs, patients on dual antiplatelet therapy, infection at the site of puncture, patient refusal, allergy 
to local anesthetics. 
* Chronic opiate consumption (>30 OME/day) 
* Patient expected to be on therapeutic anticoagulation post procedure. 
* Pregnancy 
* Comorbid conditions: Any comorbid condition that in the judgment of the anesthesiologist would 
preclude the patient from any aspect of the study (ex. sepsis, possibly abnormalities of the thoracic 
spine or paravertebral anatomy such as neoplastic mass occupying the space, empyema, increased 
intracranial pressure) 
Randomization: Patients will be randomized 1:1 into one of the study groups. The groups will be 
defined as Group 1: ESP block; Group 2: PVNB.  
The goal is to include 80 patients (40 in each arm). 
Before insertion of catheter, ropivacaine 0.5% will be injected incrementally prior aspiration to 
decrease the risk of intravascular injection every 5ml. The dose will be left at discretion of the 


anesthesiologist performing the nerve block, with a volume that would provide effective 
dermatome coverage and considering the maximum possible dose to avoid local anesthetic 
toxicity. After administration of LA catheter will then be placed and left 5cm beyond the needle 
tip. 
Continuous Infusion: bupivacaine 0.0625% will be started at 6ml/h and will be titrated up to a 
max of 12ml/h. 
Bolus: patients will have access to rescue boluses of 3ml every hour, through the catheter with 
bupivacaine 0.0625% if needed. 
All patients will be assessed daily by the acute pain service. Additional pain medication will be 
available to all patients per standard of care. All patients will have access to acetaminophen 1g 
every 6hs, ketamine infusion, and opiates as needed to provide adequate analgesia. 
 
Data collection 
Preoperative period: 
In addition, to treat breakthrough pain, all patients will receive multimodal analgesia per routine. 
An excel sheet will be available to collect the patient information from EMR and the patient. 
- 
Data to be collected: age, gender, type of surgery, type of anesthesia (including  
medications and type regional anesthesia received). 
- 
Incentive spirometer baseline  measure prior to surgery 
- 
dermatomal spread (pinprick and or changes in temperature (cold or hot) sensation) after 
15-20mins of initial bolus will be documented. 
 
Postoperative period: 
In PACU:  
- 
Intraoperative opiate consumption in (morphine equivalent dose) and while in PACU. 
- 
pain scores using the numeric rating scale. 
- 
insertion site and number of catheters will be documented 
- 
dermatomal spread (pinprick and or changes in temperature (cold or hot) sensation) will be 
documented.  
- 
number of chest tubes and sites 
Postoperative period 
- 
total opioid consumption (in morphine equivalents) and pain scores on the numeric pain 
rating scale will be documented every 6hs for the first 24hs. 
- 
Incentive spirometer daily score postoperatively 
- 
Length of stay,  


- 
Duration of catheter 
- 
Use of  additional pain medication will be recorded 
- 
Document adverse events or complications related to nerve blocks 
- 
dermatome spread with infusion infusion will be documented.