Clinical trial NCT05044429
Conditions: Kidney Transplant; Complications Pain, Postoperative
Sponsor: George Washington University
Start date: 2021-03-16; Completion date: 2023-11-29
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to compare the effectiveness of a regional anesthetic block vs systemic intravenous (IV) lidocaine in controlling post-operative pain in kidney transplantation patients. Regional anesthetic blocks and lidocaine infusions are effective alternatives to opioid medications and are already in use at many institutions. However, there has been no prospective study comparing their effectiveness when used in conjunction with the current standard of care patient controlled analgesia (PCA) pumps. This study is a prospective, randomized evaluation of both treatment methods.

Detailed description:
Adequate postoperative pain control is an important part of the patients' recovery. Renal transplant patients often have multiple comorbidities, that when combined with poorly controlled postoperative pain, can lead to tachycardia, hypertension, and increased risk of respiratory complications, which can in turn affect overall recovery and graft survival.

The use of patient-controlled analgesia (PCA) pumps is currently considered the standard of care in treating surgical pain in the immediate postoperative period. Although a traditional mainstay of therapy, opioids have an unfavorable side effect profile that includes respiratory depression, nausea, postoperative ileus, sedation, and pruritus. Additionally, long-term opioid use is linked with opioid tolerance, addiction, and patient death. Patients that have high-level opioid use in the first year posttransplant have been found to have high rates of death and all-cause graft failure.

Recently, there has been a shift in post-operative pain management to utilize a multimodal approach of both non-pharmacologic and pharmacologic therapies. As a result, the use of other non-opioid therapies, such as lidocaine infusions and regional anesthetic techniques, like transverse abdominis plane blocks, have recently increased in popularity in perioperative pain management of renal transplant patients.

Intravenous lidocaine has an off label indication as analgesic and has good evidence for use in other areas such as colorectal surgery, trauma and orthopedics. Lidocaine infusions have a strong record of safety with relatively benign adverse side effects. Although data is promising, there is little established evidence of perioperative lidocaine infusions in renal transplant populations.

Transverse abdominis plane (TAP) blocks and quadratus lumborum (QL) blocks have emerged as a significant regional technique in the application of multimodal analgesia for abdominal surgeries. Historically, TAP and QL catheters are avoided due to concern about infection near the operative site in immunosuppressed transplant patients. Establishing intravenous lidocaine as an effective treatment option will allow physicians to avoid the side effects of opioids and the infection risks of TAP and QL catheter blocks.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Intravenous Lidocaine intervention 2: Transversus abdominis plane (TAP) block intervention 3: Quadratus Lumborum (QL) Block
Intervention descriptions: intervention 1: Patient will receive intravenous lidocaine 1.0-1.5 mg/kg/hour for 48 hours post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump) intervention 2: Subject will receive 0.2% Ropivacaine at 6-10ml/hour through transversus abdominis plane (TAP) block for up to five days post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump) intervention 3: Subject will receive 0.2% Ropivacaine at 6-10ml/hour through quadratus lumborum (QL) block for up to five days post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)

Protocol documents:
Prot_SAP_000.pdf: 
RESEARCH PROPOSAL
v1.2.11Nov2020
General Information
Principal Investigator: Marian Sherman, MD
GW Medical Faculty Associates
Department of Anesthesiology and Critical Care Medicine, 
2300 M St NW, 7th Floor, Suite 737
Washington DC, 20037
Email: msherman@mfa.gwu.edu 
Office: 202-715-4750
Co-Investigators: Dr. Eric Heinz
                               Department of Anesthesiology and Critical Care Medicine
                   heinz.md.phd@gmail.com 
                               Dr. Sam Gumbert
                               Department of Anesthesiology and Critical Care Medicine
                               sgumbert@mfa.gwu.edu
                               Dr. Keith Melancon
                               Department of Surgery, Division of Transplantation
                               jmelancon@mfa.gwu.edu
Study Information
Study location: 
George Washington University Hospital
900 23rd St NW
Washington DC, 20037
Study Title: 
Postoperative pain control with Systemic Lidocaine vs Regional Anesthesia in 
Renal Transplant Patients
Study Type:
Randomized trial
Study Duration: 
36 months (Jan 2021 - Dec 2023) 
IRB NUMBER: NCR202221
IRB APPROVAL DATE: 02/18/2021


Title: Postoperative Pain Control with Systemic Lidocaine vs Regional Anesthesia in Renal Transplant 
Patients
Background
GWU does about 75 kidney transplants a year. Adequate postoperative pain control is an important part 
of the patients’ recovery. Renal transplant patients often have multiple comorbidities, that when combined 
with poorly controlled postoperative pain, can lead to tachycardia, hypertension, and increased risk of 
respiratory complications, which can in turn affect overall recovery and graft survival.
The use of patient-controlled analgesia (PCA) pumps is currently considered the standard of care in 
treating surgical pain in the immediate postoperative period [1]. Although a traditional mainstay of 
therapy, opioids have an unfavorable side effect profile that includes respiratory depression, nausea, 
postoperative ileus, sedation, and pruritus. Additionally, long-term opioid use is linked with opioid 
tolerance, addiction, and patient death. Patients that have high-level opioid use in the first year post-
transplant have been found to have high rates of death and all-cause graft failure [2]. 
Recently, there has been a shift in post-operative pain management to utilize a multimodal approach of 
both non-pharmacologic and pharmacologic therapies. As a result, the use of other non-opioid therapies, 
such as lidocaine infusions and regional anesthetic techniques, like transverse abdominis plane blocks, 
have recently increased in popularity in perioperative pain management of renal transplant patients [3].
Intravenous lidocaine has an off label indication as analgesic and has good evidence for use in other 
areas such as colorectal surgery, trauma and orthopedics. Lidocaine infusions have a strong record of 
safety with relatively benign adverse side effects. Although data is promising, there is little established 
evidence of perioperative lidocaine infusions in renal transplant populations.
Transverse abdominis plane (TAP) blocks have emerged as a significant regional technique in the 
application of multimodal analgesia for abdominal surgeries. Historically, TAP catheters are avoided due 
to concern about infection near the operative site in immunosuppressed transplant patients. Establishing 
intravenous lidocaine as an effective treatment option will allow physicians to avoid the side effects of 
opioids and the infection risks of TAP catheter blocks. 
Aims:
1. To see if Lidocaine infusion is non-inferior to TAP catheters for postoperative pain control
2. To see if higher rates of complications arise from non-opioid techniques (infection rates from TAP 
catheters, anesthetic toxicity from lidocaine infusion)
Recruitment: Recruitment for this study will take place in the preop waiting area. During that time, the 
purpose and method of the study will be explained to the patient. Patients will be informed of risks, 
benefits, and alternatives to participation in the study and will have the opportunity to sign consent after 
review of documentation and having all questions answered.
Recruitment cannot be done prior to the preop area because transplant surgeries are not scheduled far in 
advance. The organ recipient is called into the hospital when a match is found. The research team will be 
notified as soon as possible when a renal transplant is scheduled to allow for maximum amount of time to 
obtain consent.
Inclusion: 
Single Kidney transplant, >18 years old
Exclusion: 
Long term use of opioids (e.g. Chronic pain patients), history of substance abuse
Local anesthetic allergy
Complicated surgical course
●
Intraoperative damage to other organs e.g. bowel
IRB NUMBER: NCR202221
IRB APPROVAL DATE: 02/18/2021


●
Return to OR within 72 hours 
●
Postoperative ventilation
Methodology
Groupings
Patients will be randomly allocated into 2 groups: Lidocaine + PCA (L group) and TAP + PCA (T group). 
A member of the research team will perform the randomization and will notify the surgeon and the 
anesthesiologist on the case. This study is not blinded.  
Sample size
The goal will be to recruit at least 55 patients for the Lidocaine group and 25 patients for the TAP block 
group for a total of 80 patients in all. Sample size for this study is based on information gained from a 
retrospective study of renal transplant patients. The aim is to demonstrate non-inferiority of lidocaine to 
TAP block where non-inferiority is defined as <10% difference in OME consumption (with a 95% 
confidence interval) between the groups. 
Intervention
When a renal transplant case is posted to the OR schedule, the research team will be notified. A team 
member will then meet with the patient in the preop area to obtain informed consent. Once consent is 
obtained, the medical records of the patient will be screened for exclusion criteria. If the patient meets all 
criteria, they will be randomized to one of the two study groups. 
The anesthesiologist and surgeon on the case will be informed immediately of the group assignment. 
In addition to the treatments assigned to each group, all patients will receive the standard of care 
medications given pre-op, intra-op, and post-op. These medications include oral Tylenol, oral oxycodone 
as needed, IV morphine or hydromorphone as needed, ketamine as indicated, and Ondansetron as 
needed. All patients will receive a dilaudid PCA 0.5mg bolus Q10min postoperatively as standard of care. 
Following the case, the research team will review the operative note and anesthesia postoperative note to 
identify any disqualifying surgical complications (injured bowel, patient remains intubated, complication 
requiring return to OR within 72 hours). If there are disqualifying complications, the anesthesiologist and 
the surgeon will be notified and the patient removed from the study. Any further treatment for 
postoperative pain will be per standard of care and the surgeon’s discretion. 
If there are no disqualifying surgical complications, the following orders for postoperative pain control will 
be placed per the patient’s assigned group: 
●
Lidocaine (+PCA): 1.0-1.5 mg/kg/hour for 48 hours post-operatively.
●
TAP (+PCA): 0.2% Ropivacaine at 6-10ml/hour for up to five days post-operatively.
Nursing will routinely record VAS scores for all patients per nursing standard of care.  
The research team will review patient charts daily to obtain the VAS scores and total narcotics used at 12 
hours, 24 hours, and 48 hours as well as any notes regarding complications. 
Signs of complications due to the treatment methods will be reason to terminate the study and remove 
that patient from the study. Possible risks are listed below. The surgical team may terminate these 
treatment modalities as soon as a complication is identified, and may inform the research team as soon 
as possible afterwards. 
Measures: 
Demographics (age, gender, race, ASA)
Pain metrics at 12, 24, 48 hours (Time zero is arrival in PACU)
IRB NUMBER: NCR202221
IRB APPROVAL DATE: 02/18/2021


-
Oral morphine Equivalents
-
VAS score
Duration of operation
Surgeon
Length of stay (date of operation to date of discharge)
Complications 
-
Sepsis requiring antibiotic therapy
-
Acute rejection of transplant
-
Local Anesthetic Systemic Toxicity
-
Need for CVVHDF
-
Opioid toxicity requiring naloxone
-
Ileus
Risks: 
Risk of lidocaine infusion: Lidocaine toxicity (lightheadedness, dizziness, visual disturbances, confusion, 
tinnitus, and perioral numbness/peripheral paresthesia) 
Risk of TAP block: local infection, hematoma, poor placement leading to inadequate pain control
Endpoints:
-
VAS score
-
Total opiate usage in morphine equivalents 
Expected outcome and significance:
It is expected that patients with patients receiving lidocaine infusion will have equivalent opioid 
consumption and pain scores compared to patients receiving TAP blocks in the first 48 hours after 
surgery. If lidocaine infusion is demonstrated to be non-inferior to TAP blocks, this would provide 
physicians with an alternative to TAP blocks in controlling post-surgical pain while reducing total opioid 
usage.  
Timetable: 36 months
References
1. Farag E, Guirguis MN, Helou M, et al. Continuous transversus abdominis plane block catheter 
analgesia for postoperative pain control in renal transplant. J Anesth. 2015;29(1):4-8.
2. Lentine KL, Lam NN, Naik AS, et al. Prescription opioid use before and after kidney transplant: 
Implications for posttransplant outcomes. Am J Transplant. 2018;18(12):2987-2999.
3. Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of 
transversus abdominis plane block. J Clin Anesth. 2011;23(1):7-14.
IRB NUMBER: NCR202221
IRB APPROVAL DATE: 02/18/2021

ICF_001.pdf: 
Study Assigned Consent Version 1.5/Date: 8Dec2020GW OHR Document Revision Date: 04Jan2019
Page 1 of 8
Informed Consent for Participation in a Research Study
Title of Research Study: Postoperative Pain Control with Systemic Lidocaine vs Regional Anesthesia in 
Renal Transplant Patients
Investigator: Dr. Marian Sherman, Anesthesiology and Critical Care Medicine
Key Information:
You are being asked to take part in a research study about ways to treat surgical pain after a kidney transplant. 
This page will give you key information to help you decide whether or not you want to participate in this study. 
More detailed information can be found on the next pages. Ask the research team questions during the consent 
process, and use the contact information on this form to ask questions later. 
WHAT IS THE PURPOSE, PROCEDURES, AND DURATION OF THIS STUDY?
This study aims to determine whether a nerve blocks or a lidocaine infusion is better at controlling pain after 
kidney transplantation. While nerve blocks and lidocaine infusions are both effective ways to control pain and 
are already in use at GW hospital, there has been no study comparing which is better at controlling pain after 
kidney transplantation. By doing this study, we hope to learn which treatment method yields better pain control. 
Your participation in this research will last about 48 hours after your surgery. 
WHAT ARE THE REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY?
While this study might not have direct benefit to you, the information we learn from this study will help physicians 
better treat post-surgical pain and identify ways of treating post-operative pain without using opioid pain 
medication. For a complete description of benefits please refer to the Detailed Consent. 
WHAT ARE THE REASONS YOU MIGHT NOT CHOOSE TO VOLUNTEER FOR THIS STUDY?
As with any medication, there are risks to receiving lidocaine or ropivacaine (the medication used in nerve 
blocks). While these drugs are relatively safe and already used regularly here at GW hospital, we will still take 
all necessary precautions when administering these medications. For a complete description of risks please 
refer to the Detailed Consent. 
DO YOU HAVE TO TAKE PART IN THIS STUDY?
You do not have to take part in this research.  It is your choice whether or not you want to take part. You can 
agree to take part and later change your mind.  If you choose not to take part or choose to stop taking part at 
any time, there will be no penalty to you or loss of benefits to which you are otherwise entitled.
WHAT IF YOU HAVE QUESTIONS OR CONCERNS?
The person in charge of this study is Dr. Marian Sherman.  If you have questions, suggestions, or concerns 
regarding this study or you want to withdraw from the study, her contact information is: 
Dr. Marian Sherman
Anesthesiology and Critical Care Medicine, GW Medical Faculty Associates 
2300 M St. NW, 7th floor
Washington DC, 20037
msherman@mfa.gwu.edu 
202-715-4750
 
This research is being overseen by an Institutional Review Board (“IRB”). You may talk to them at 202-994-2715 
or via email at ohrirb@gwu.edu if:
 
You have questions, concerns, or complaints that are not being answered by the research team or if 
you wish to talk to someone independent of the research team.

You have questions about your rights as a research subject.
IRB NUMBER: NCR202221
IRB APPROVAL DATE: 02/18/2021


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Page 2 of 8
Detailed Consent Form:
Why am I being invited to take part in a research study?
We invite you to take part in a research study because your medical records show you will be 
receiving a kidney transplant. 
What should I know about a research study?

Someone will explain this research study to you. You may ask all the questions you 
want before you decide whether to participate.

Participation is voluntary; whether or not you take part is up to you.

You can agree to take part and later change your mind.

Your decision not to take part or to stop your participation will not be held against you.

Your decision will not affect the medical care you receive from GW. If you decide not 
to take part, you can still receive medical care from GW.

You may discuss with your family members or doctor before deciding to take part in 
this research study.
ClinicalTrials.gov is a website that provides information about federally and privately 
supported clinical trials. A description of this clinical trial will be available on 
http://www.ClinicalTrials.gov, as required by U.S. 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.
Who can I talk to if I have questions?
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the 
Principal Investigator at:
Dr. Marian Sherman
Anesthesiology and Critical Care Medicine, GW Medical Faculty Associates 
2300 M St. NW, 7th floor
Washington DC, 20037
msherman@mfa.gwu.edu 
202-715-4750
This research is being overseen by an Institutional Review Board (“IRB”). You may talk to 
them at 202-994-2715 or via email at ohrirb@gwu.edu if:

You have questions, concerns, or complaints that are not being answered by the 
research team or if you wish to talk to someone independent of the research team.

You have questions about your rights as a research subject.
Why is this research being done?
This study aims to compare the effectiveness of different ways of treating pain after a kidney 
transplant surgery. The goal is to find ways to treat surgical pain while using as little opioid 
medication as possible. 
IRB NUMBER: NCR202221
IRB APPROVAL DATE: 02/18/2021


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How long will I be in the study?
We expect that you will be in this research study for 48 hours following your surgery. 
How many people will take part in this research study?
We expect about 80 people will take part in the entire study.
What happens if I agree to be in this research?
Your involvement in this study will begin once you reach the post-anesthesia care unit 
(PACU) following surgery and last for 48 hours. 
All patients, regardless of participation in this study, will receive a patient-controlled analgesia 
(PCA) pump as part of standard post-surgical care. The PCA pump is a device filled with pain 
medication, typically Dilaudid, and connected to the patient through an IV line. Dilaudid is an 
opioid medication regularly used to treat post-surgical pain. A computerized pump attached to 
the IV lets you release pain medicine by pressing a handheld button. The device is 
programed limit the amount of medication delivered every hour to prevent overdose. If you 
participate in this study, you will receive a PCA pump in addition to the different pain control 
methods being examined in this study. 
Your study group assignment will be chosen by chance, like flipping a coin. You will have an 
equal chance of being assigned to any of the following two groups:
1. Lidocaine group: this group will receive lidocaine infusion through an IV in addition to a 
PCA pump. Lidocaine (a non-opioid analgesic) is a medication typically injected under 
the skin to cause local numbness. When infused through an IV, lidocaine will decrease 
the overall level of pain throughout the body. For this study, lidocaine will be 
administered through an IV bag and will be infused continuously through an IV line 
while you are in the hospital. 
2. Nerve block group: this group will receive a nerve block catheter in addition to a PCA 
pump. This is a catheter that is inserted through the skin near the surgical site and is 
placed while in the operating room as part of the kidney transplant surgery. This 
catheter is left in place for several days. This catheter is connected to a medication 
pump that will infuse a numbing medication, Ropivacaine, into the tissue and muscle 
(transverse abdominis muscle specifically) around the surgical site. 
Besides these treatments, you will receive all the standard medications and treatments for 
postoperative pain that kidney transplant patients normally receive. During your hospital stay, 
your nurse will regularly ask you to rate your pain level. This is part of your routine care while 
admitted and would be done regardless if you participate in this research project or not. The 
research team will collect information about your recovery for 48 hours following your 
surgery. This information will be collected from your medical chart. 
If you agree to participate in this study, a copy of this consent form will be placed in your 
medical records. 
IRB NUMBER: NCR202221
IRB APPROVAL DATE: 02/18/2021


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What are my responsibilities if I take part in this research?
While in the hospital, your nurse will regularly ask you to rate your pain level. This is part of 
your routine care while admitted and would be done regardless if you participate in this 
research project or not.
What other choices do I have besides taking part in the research?
The alternative to participating in this research study is to not participate. The standard of 
care you will receive will not be affected by your decision to participate in this study. 
If you decide to not participate in or to withdraw from this study, it is still possible that your 
surgeon may prescribe a PCA, lidocaine infusion, or nerve block. At GW Hospital, these 
treatment methods are frequently used to control pain after large surgeries and are 
prescribed based on the choice of your surgeon.  
What happens if I agree to be in research, but later change my mind?
You may refuse to participate or you may discontinue your participation without penalty or 
loss of benefits to which you would otherwise be entitled. If you decide to leave the research, 
you will receive the standard of care for post-renal transplant surgery.
If you decide to leave the research, contact the investigator so that the research team can 
remove any data that was collected on you from the research files. 
Is there any way being in this study could be bad for me?
Risks of Patient Controlled Analgesia (PCA): opioid overdose, dangerously slow breathing 
rate (respiratory suppression), tiredness, itching, constipation, risk of opioid addiction, allergic 
reaction to opioids.
The PCA is the current standard of care. You will receive a PCA regardless of the study 
group you are placed in. Standard precautions against risks include heart and oxygen 
saturation monitors (for overdose, respiratory suppression, and lethargy), a lock out button on 
the pump that limits the amount of medication you can receive (prevent overdose), stool 
softeners (for constipation), and reducing dose of opioid medications as quickly as possible 
(avoid addiction).
Risks of Lidocaine infusion: allergic reaction to lidocaine, lidocaine toxicity (symptoms include 
lightheadedness, dizziness, visual changes, confusion, ringing in the ears, and numbness 
around the mouth and in the fingers)
You cannot participate in this study if you have a history of allergies to lidocaine or similar 
local anesthetic. If you receive lidocaine as part of this study, you will be monitored for signs 
of lidocaine allergy or toxicity. If adverse reactions to lidocaine are noted, the lidocaine will be 
stopped and you will be treated per standard of care. If this were to happen, you will be 
removed from the study. 
Risks of nerve block: local infection, large area of bruising, poor placement leading to poor 
pain control
The nerve block catheter will be placed in the operating room to best ensure correct 
placement, avoid bleeding and hematoma (pooling of blood under the skin) formation, and to 
IRB NUMBER: NCR202221
IRB APPROVAL DATE: 02/18/2021


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minimize risk of infection. The insertion site of the nerve block catheter will be examined per 
standard of care by the surgical team. If infection or a hematoma is noted, the catheter will be 
removed per standard of care and the infection or hematoma will be treated per standard of 
care.
There is always a minimal risk of loss of confidentiality in the process of data collection and 
analysis. Appropriate precautions will be taken to safeguard all patient information. 
You and your insurance company will be charged for the health care services that you would 
ordinarily be responsible to pay. All services provided in this study are standard of care or are 
routinely used adjuncts to standard of care and may be provided to you whether or not you 
participate in this study. As with all care that you receive in the hospital, you should check 
with your insurance to see what services will be covered by your insurance and what you will 
be responsible to pay.
What happens if I believe I am injured because I took part in this study?
The researchers have taken steps to minimize the known or expected risks. In spite of all 
precautions, you still may experience medical complications or side effects from participating 
in this study. You should promptly notify the study doctor in the event of any illness or injury 
as a result of being in the study.
If you believe that you have been injured or have become ill from taking part in this study, you 
should seek medical treatment from GWU Hospital and/or the GWU MFA or through your 
physician or treatment center of choice. Care for such injuries will be billed in the ordinary 
manner to you or your insurance company. 
You will not receive any financial payments from GWU, GWU Hospital and/or the GWU MFA 
for any injuries or illnesses. You do not waive any liability rights for personal injury by signing 
this form.
Will being in this study help me in any way?
We cannot promise any direct benefits to you or others from your taking part in this research. 
Previous studies have shown that lidocaine infusions and nerve blocks may decrease the 
need for opioid medications, but this is not guaranteed. It is also not guaranteed that your 
overall pain levels will be less by taking part in this research. Data from this study will be used 
to design more effective treatments for post-surgical pain for future patients.  
Can I be removed from the research without my permission?
The person in charge of the research study can remove you from the research study without 
your approval. Possible reasons for removal include having an allergic reaction to or medical 
complication from one of the medications, or having a complication from your surgery that 
requires you to be on a treatment plan different from what can be given in this study. 
We will tell you about any new information that may affect your health, welfare, or choice to 
stay in the research.
IRB NUMBER: NCR202221
IRB APPROVAL DATE: 02/18/2021


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What happens to my information collected for the research?
Only data necessary to this study will be collected. Any data that is collected will be securely 
stored. To the extent allowed by law, we limit your personal information to people who have 
to review it. We cannot promise complete secrecy. The IRB and other representatives of this 
organization may inspect and copy your information. 
How will my privacy and health information be protected?
The Health Insurance Portability and Accountability Act (HIPAA) requires that researchers 
and health care providers protect the privacy of information that identifies you and relates to 
your past, present and future physical and mental health or conditions, or the provision of 
health care. If you agree to participate in this research, protected health information will be 
used and shared with others for purposes of the study. Below is more detailed information 
about how your health information will be shared and protected.  By signing this form, you are 
allowing the people and groups that are listed in the next paragraphs to use your health 
information for this research study.  Your information will only be used or shared as explained 
in this authorization form.
The use and release of protected health information is for the purpose of collecting data for 
this study.
Protected Health Information to be shared: age, gender, date of surgery, date of 
hospitalization, date of discharge from the hospital, medical history, medications given in the 
hospital, and prescription medicines taken at home. 
The researcher and the other members of the research team may obtain your individual 
health information from: hospital medical records and the surgery team
By signing this form, you allow the use, sharing, copying, and release of your protected 
health information in connection with this study by:
•
The members of the research team;
•
Institutional officials who are responsible for compliance;
Once your health information has been disclosed to others outside of the hospitals and 
medical practices, the information may no longer be covered by the federal regulation that 
protects privacy of health information. No part of this study requires that your information be 
disclosed to others outside of this hospital.  
Not signing this form or later canceling your permission will not affect your health care 
treatment outside the study, payment for health care from a health plan, or ability to get 
health plan benefits. However, if you do not give permission to use your health information, 
you may not take part in this study because your health information is needed in order to 
conduct this study.
This Authorization does not have an expiration date.  However, you may cancel this 
authorization at any time.  Even if you cancel this authorization, the researchers may still use 
the protected health information they already have about you; however, no new health 
information or new biological specimens will be collected from you after you cancel your 
permission.
IRB NUMBER: NCR202221
IRB APPROVAL DATE: 02/18/2021


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To cancel your permission, you will need to send a letter to Dr. Sherman stating that you are 
canceling your authorization. This letter must be signed and dated and sent to this address: 
Dr. Marian Sherman
Anesthesiology and Critical Care Medicine, GW Medical Faculty Associates 
2300 M St. NW, 7th Floor
Washington DC, 20037
msherman@mfa.gwu.edu 
202-715-4750
Are there any costs for participating in this research? 
There are no additional costs to you for participating in this research. The costs associated 
with your surgery, subsequent treatments, and hospital stay will be billed to you or your 
insurance as it normally would regardless of your participation in this study.  
Will I be paid for my participation in this research? 
No, there will be no payment for participation in this research. 
IRB NUMBER: NCR202221
IRB APPROVAL DATE: 02/18/2021


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Signature Block for Adult
By signing below, you agree that the above information has been explained to you and you 
have had the opportunity to ask questions. You understand that you may ask questions about 
any aspect of this research during the course of the study and in the future. Your signature 
documents your permission to take part in this research. 
_______________________________
Printed name of subject
 _______________________________
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Signature of subject
Date
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Signature of person obtaining consent
Date
IRB NUMBER: NCR202221
IRB APPROVAL DATE: 02/18/2021