Clinical trial NCT04073056
Conditions: Morbid Obesity High BMI
Keywords: Sleeve gastrectomy Quadratus lumborum block Bariatric surgery
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2018-08-01; Completion date: 2021-02-23
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The QL 2 block is a novel fascial plane block recently described by Blanco and colleagues in which local anesthetic is deposited adjacent to the antero-lateral aspect of the quadratus lumborum muscle. This results in posterior spread of local anesthetic through the middle layer of the thoraco-lumbar fascia, which theoretically communicates with the paravertebral space resulting in potentially longer-lasting and denser analgesia than wound infiltration. The QL 2 block derives from the TAP block, which is also a fascial plane block that is commonly used to treat pain following surgery involving the anterior abdominal wall. However, the QL block's more posterior location has recently been shown to provide a longer lasting and more profound analgesic effect than the TAP block, possibly by communicating with the paravertebral space. Although the TAP has been shown to be effective in a variety of surgical procedures involving an anterior abdominal wall incision including laparoscopic bariatric surgery the QL 2 block has until now, not been studied in the context of bariatric surgery.

Detailed description:
The QL 2 block is a novel fascial plane block recently described by Blanco and colleagues in which local anesthetic is deposited adjacent to the antero-lateral aspect of the quadratus lumborum muscle. This results in posterior spread of local anesthetic through the middle layer of the thoraco-lumbar fascia, which theoretically communicates with the paravertebral space resulting in potentially longer-lasting and denser analgesia than wound infiltration. Like the more commonly used transversus abdominis plane (TAP) block, the QL 2 block targets the anterior rami of T7-T12, ilioinguinal, iliohypogastric, and the lateral cutaneous branches of L1-L3. The QL 2 block derives from the TAP block, which is also a fascial plane block that is commonly used to treat pain following surgery involving the anterior abdominal wall. However, the QL block's more posterior location has recently been shown to provide a longer lasting and more profound analgesic effect than the TAP block, possibly by communicating with the paravertebral space. Although the TAP has been shown to be effective in a variety of surgical procedures involving an anterior abdominal wall incision including laparoscopic bariatric surgery the QL 2 block has until now, not been studied in the context of bariatric surgery. Conventional therapy has consisted of surgical infiltration of the incision ports with bupivacaine 0.25%. The study team proposes a study to compare the analgesic effects of the QL 2 block with conventional therapy, consisting of surgical wound infiltration, for postoperative analgesia following laparoscopic gastric sleeve gastrectomy.

Arms: arm 1: The QL 2 group will receive 15 mL bupivacaine 0.25% on both sides for a total of 30 mL once the surgery is done but prior to extubation under ultrasound guidance. arm 2: Conventional therapy consists of the injection of 30 mL of bupivacaine 0.25% directly into the incision sites by the surgeon at the end of the procedure.
Interventions: intervention 1: Bupivacaine
Intervention descriptions: intervention 1: Bupivacaine Hcl 0.25% Inj

Protocol documents:
ICF_001.pdf: 
THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Mount Sinai St. Luke’s, Mount Sinai West 
Page 1 of 14
Study ID #: 18-00381
Form Version Date: 05/11/2018
TITLE OF RESEARCH STUDY:
Quadratus Lumborum 2 Block vs Conventional Therapy Alone for Laparoscopic Sleeve Gastrectomy
Surgery
PRINCIPAL  INVESTIGATOR  (HEAD  RESEARCHER)  NAME  AND  CONTACT
INFORMATION:
Name: Ali Shariat
Physical Address:  Mount Sinai St. Luke’s Hospital.  1111 Amsterdam Ave, New York, NY
10025. 
Mailing Address: Mount Sinai St. Luke’s Hospital.  1111 Amsterdam Ave, New York, NY  
10025.
Phone: 212-523-2500
WHAT IS A RESEARCH STUDY?
A research study is when scientists try to answer a question about something that we don’t know
enough about.  Participating may not help you or others.  
People volunteer to be in a research study.  The decision about whether or not to take part is totally
up to you. You can also agree to take part now and later change your mind. Whatever you decide is
okay.  It will not affect your ability to get medical care within the Mount Sinai Health System.  
Someone will explain this research study to you. Feel free to ask all the questions you want before
you decide.  Any new information that develops during this research study that might make you
change your mind about participating will be given to you promptly.
Basic information about this study will appear on the website http://www.ClinicalTrials.gov.  There are
a few reasons for this:  the National Institutes of Health (NIH) encourages all researchers to post their
research; some medical journals only accept articles if the research was posted on the website; and,
for research studies the U.S. Food and Drug Administration (FDA) calls "applicable clinical trials” a
description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S.
Law. This Web site will not include information that can identify you. At most, the Web site will include
a summary of the results. You can search this Web site at any time.
PURPOSE OF THIS RESEARCH STUDY:
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Page 2 of 14
Study ID #: 18-00381
Form Version Date: 05/11/2018
You are here because you are scheduled to undergo a laparoscopic sleeve 
gastrectomy operation for weight reduction. The need for the surgery and your 
eligibility should have been determined and discussed by your surgeon.
The purpose of this study is to compare the pain relief that patients get from 
either conventional therapy with surgical wound infiltration with local anesthetics
or the quadratus lumborum 2 (QL 2) block for patients having laparoscopic 
sleeve gastrectomy surgery. Conventional therapy means that a local anesthetic
called bupivacaine 0.25% is injected directly into the tissue of the abdomen 
where the surgeon cuts. This conventional therapy has been used for many 
years, however the quality of pain control and the amount of time that patients 
remain pain-free is limited. For this reason, we want to compare pain relief with 
conventional therapy to the pain relief using a technique called the QL 2 block. 
The QL 2 block consists of injecting bupivacaine 0.25% into the outer layers of 
the quadratus lumborum muscle in the abdominal wall. This numbs the nerves 
that carry sensation from the abdomen and chest wall, thereby giving relief from
the pain caused by the incisions the surgeon makes to perform the surgery. 
Both conventional therapy and the QL 2 block will be performed when you are 
still asleep. All patients will have general anesthesia (GA) which means that you
will go to sleep with medications given in your intravenous (IV) line and have a 
breathing tube placed after you go to sleep. For this study, you will either 
receive conventional therapy or the QL 2 block.
The anesthesiologist in charge of this study will decide if you qualify for this trial.
To qualify you must be scheduled to undergo a laparoscopic sleeve 
gastrectomy procedure and you must be medically able to receive both general 
anesthesia and the QL 2 block, as well as, being 18-65 years of age and have a
body mass index (BMI) >35 kg/m2.  You will not be eligible for this trial if you 
have a history of allergy to local anesthetics, ketorolac, acetaminophen, or 
opioids, have a condition that would make it difficult for you to communicate with
your doctor, or have a recent history of drug or alcohol abuse.
If you qualify, your doctor will explain the trial to you, including the risks and 
benefits so that you can decide if you would like to take part. If you decide to be 
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THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Mount Sinai St. Luke’s, Mount Sinai West 
Page 3 of 14
Study ID #: 18-00381
Form Version Date: 05/11/2018
a part of the trial, your doctor will then open the trial randomization envelope to 
find out which treatment group you will be assigned to.
Funds for this research project are provided by Mount Sinai-St. Luke’s and
Mount Sinai-West Hospitals.
LENGTH OF TIME AND NUMBER OF PEOPLE EXPECTED TO PARTICIPATE
Your participation in this research study is expected to last 48 hours.
The number of people expected to take part in this research study at Mount 
Sinai-St. Luke’s and Mount Sinai West Hospitals is 110.
DESCRIPTION OF WHAT’S INVOLVED:
On the day of your surgery, you will be assessed by the anesthesia and surgical
teams. If you qualify for the study, you will receive either the QL 2 block or
conventional therapy. Conventional therapy consists of the surgeon injecting
bupivacaine 0.25% into the incision sites at the end of the procedure. The study
treatment you get will be chosen by chance, like flipping a coin. Neither you nor
the study doctor will choose which study treatment you get. You will have a one
in two chance of being given each study treatment. You will not know which
study  treatment  you  are  getting.  This  information  can  be  obtained  in  an
emergency, however. You will not be told which study treatment you are getting,
however your study doctor will know.
All procedures involved in this study will be performed at Mount Sinai-St. Luke’s
and Mount Sinai West Hospitals. Although the QL 2 block has been already
extensively used for other surgeries, its ability to prevent pain in laparoscopic
sleeve gastrectomies is being investigated here. We will be investigating two
methods that are widely used for pain control and comparing them with each
other. All drugs are being used in accordance with product labeling.
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THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Mount Sinai St. Luke’s, Mount Sinai West 
Page 4 of 14
Study ID #: 18-00381
Form Version Date: 05/11/2018
The main anesthetic for your surgery is called general anesthesia, which means
you will be going to sleep after being given anesthetic mediactions through an 
intravenous line that will be placed by your anesthesiologist. After you are 
asleep, a breathing tube will be placed and your breathing will be controlled by a
ventilator. Your blood pressure, oxygenation, heart rate, and breathing will be 
monitored throughout the performance of the anesthesia and surgery. If you are
randomized to the conventional therapy group, then at the end of the procedure,
but before you wake up, your surgeon will inject the incision sites with 
bupivacaine 0.25%. If you are randomized to the QL 2 group, then at the end of 
the procedure but before you wake up, your anesthesiologist will perform the QL
2 block. For the QL 2 block, an ultrasound probe will be placed on your 
abdomen and the correct muscle layers will be identified. The block needle will 
then be placed adjacent to the quadratus lumborum muscle under ultrasound 
visualization and the bupivacaine 0.25% will be injected into the lining of the 
muscle. A block needle consists of a hollow needle attached to tubing and a 
syringe is used to inject local anesthetic. The block needle is visible under the 
ultrasound and can therefore be placed in the correct location to do the QL 2 
block. You will then wake up and the breathing tube will be removed in the 
operating room.
You will then be taken to the recovery room where you will be monitored by the 
nursing staff and assessed every hour by a researcher for the time that you 
remain in the recovery room. Things that will be assessed for data collection 
include your pain level, amount of pain medication consumed, and vital signs. 
You will be assessed several times by a member of the research team over the 
course of 48 hours after your surgery.
This study does not entail pregnancy risks, however a urine pregnancy test will 
be done for all female patients on the day of your surgery as part of the routine 
testing that is performed prior to surgery.
YOUR RESPONSIBILITIES IF YOU TAKE PART IN THIS RESEARCH:
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THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Mount Sinai St. Luke’s, Mount Sinai West 
Page 5 of 14
Study ID #: 18-00381
Form Version Date: 05/11/2018
If you decide to take part in this research study you will be responsible for the
following things: answering questions about things like your pain, how much
pain medicine you required, and the your general medical health. A member of
the research team will be asking you these questions and your answers will be
written on a data collection form that will then be entered into a computer
database that will be encoded to keep your identity private. The data collection
form itself will be stored in a locked cabinet in Mount Sinai-St. Luke’s Hospital.
COSTS OR PAYMENTS THAT MAY RESULT FROM PARTICIPATION:
You will  not  be  paid  for participating  in  this research study.  Being in this
research study will not lead to extra costs to you. You will not be reimbursed for
your travel or time that may be required for study visits. 
POSSIBLE BENEFITS:
It is important to know that you may not get any benefit from taking part in this 
research.  Others may not benefit either.  However, possible benefits if you 
receive a QL 2 block may be a decrease in pain and the need for additional pain
medications that are given by mouth or through your intravenous line. These 
pain medications have side effects such as nausea, vomiting, slowing of the 
breathing rate, and sedation.
REASONABLY FORESEEABLE RISKS AND DISCOMFORTS:
There is a small risk, as with any injection, of bleeding or infection with insertion 
of the block needle.
Serious side effects such as a seizure or cardiac arrest related to bupivacaine 
0.25% are rare, but may occur if too much is given or if it is accidentally injected
into a blood vessel instead of into the surrounding tissues. 
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THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Mount Sinai St. Luke’s, Mount Sinai West 
Page 6 of 14
Study ID #: 18-00381
Form Version Date: 05/11/2018
The numbing sensation caused by bupivacaine 0.25% may be persistent, with 
slow, incomplete, or no recovery. Sometimes a tingling sensation may appear in
the area treated with local anesthetic. 
Allergic reactions are rare, but may include rash, itching and redness of the 
skin, sneezing, nausea, vomiting, dizziness, fainting, sweating, fever, and low 
blood pressure. 
If you experience any of the above side effects or other symptoms, you should 
notify the study doctor or study staff immediately.
By signing this Informed Consent Form, you do not give up any legal rights that 
you otherwise have as a subject in a research study. There always exists the 
potential for loss of private information; however, there are procedures in place 
to minimize this risk.  
OTHER POSSIBLE OPTIONS TO CONSIDER:
You may decide not to take part in this research study without any penalty.  The choice is
totally up to you. 
Other options to treat postoperative pain are available and include the placement of local
anesthesia into the area where the surgeon is working and opioid medications into your
intravenous line.  
The risks of these treatment options include absorption of the local anesthesia into your
blood which can cause seizures or stop your heart. 
Please talk to your doctor about these choices and their side-effects before deciding if you 
will take part in this study.
IN CASE OF INJURY DURING THIS RESEARCH STUDY:
If you are injured or made sick from taking part in this research study, medical 
care will be provided. The sponsor will reimburse your reasonable and 
necessary medical expenses for diagnosis and treatment of a research-related 
injury or illness.
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THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Mount Sinai St. Luke’s, Mount Sinai West 
Page 7 of 14
Study ID #: 18-00381
Form Version Date: 05/11/2018
This does not prevent you from seeking payment for injury related to 
malpractice or negligence. Contact the investigator for more information.
ENDING PARTICIPATION IN THE RESEARCH STUDY:
You may stop taking part in this research study at any time without any penalty.
This will not affect your ability to receive medical care at any of the Mount Sinai
Health System hospitals or to receive any benefits to which you are otherwise
entitled.
If you decide to stop being in the research study, please contact the Principal
Investigator or the research staff.   
You may also withdraw your permission for the use and disclosure of any of
your protected information for research, but  you must do so in writing to the
Principal Investigator at the address on the first page. Even if you withdraw your
permission, the Principal Investigator for the research study may still use the
information  that  was  already  collected  if  that  information  is  necessary  to
complete the research study.  Your  health information may still be used or
shared after you withdraw your authorization if you have an adverse event (a
bad effect) from participating in the research study.
Withdrawal without your consent: The study doctor, the sponsor or the 
institution may stop your involvement in this research study at any time without 
your consent. This may be because the research study is being stopped, the 
instructions of the study team have not been followed, the investigator believes 
it is in your best interest, or for any other reason. If specimens or data have 
been stored as part of the research study, they too can be destroyed without 
your consent.
CONTACT PERSON(S):
If you have any questions, concerns, or complaints at any time about this
research, or you think the research has hurt you, please contact the office
of the research team and/or the Principal Investigator at phone number:
914-409-5023. If you experience an emergency during your participation
in this research, contact Ali Shariat, M.D. at 914-409-5023. This research
has been reviewed and approved by an Institutional Review Board.  If you
have questions about your rights as a research subject, please contact
the Patient Representative Office: 212-523-3700.
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THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Mount Sinai St. Luke’s, Mount Sinai West 
Page 8 of 14
Study ID #: 18-00381
Form Version Date: 05/11/2018
If you experience an emergency during your participation in this research,
call 9-1-1.
This research has been reviewed and approved by an Institutional Review
Board. You may reach a representative of the Program for Protection of Human
Subjects at the Icahn School of Medicine at Mount Sinai at telephone number
(212) 824-8200 during standard work hours for any of the reasons listed below.
This office will direct your call to the right person within the Mount Sinai Health
System:

Your questions, concerns, or complaints are not being answered by 
the research team.

You cannot reach the research team.

You are not comfortable talking to the research team.

You have questions about your rights as a research subject.

You want to get information or provide input about this research.
DISCLOSURE OF FINANCIAL INTERESTS:
Sometimes, physicians/researchers receive payments for consulting or similar
work performed for industry.  Effective September 2014 Mount Sinai reviews
only payments to an individual totaling more than $5,000 a year per entity when
determining  potential  conflicts  of  interest.  If  you  have  questions  regarding
industry relationships, we encourage you to talk your physician/researcher or
visit our website at http://icahn.mssm.edu/ where Mount Sinai publicly discloses
the industry relationships of our faculty. 
MAINTAINING CONFIDENTIALITY – HIPAA AUTHORIZATION:
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THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Mount Sinai St. Luke’s, Mount Sinai West 
Page 9 of 14
Study ID #: 18-00381
Form Version Date: 05/11/2018
As you take part in this research project it will be necessary for the research
team  and  others to  use  and  share  some  of  your  private  protected  health
information.  Consistent  with  the  federal  Health  Insurance  Portability  and
Accountability Act (HIPAA), we are asking your permission to receive, use and
share that information.
What protected health information is collected and used in this study, and might
also be disclosed (shared) with others?
As part of this research project, the research team at the hospital(s) involved in 
the research will collect your name, address, telephone number, and medical 
record number.
The researchers will also get information from your medical record from Mount 
Sinai St. Luke’s and Mount Sinai West Hospitals.
During the study the researchers will gather information by:
taking  a medical  history  (includes  current  and  past  medications  or
therapies,  illnesses,  conditions  or  symptoms,  family  medical  history,
allergies, etc.)
doing a physical examination that generally also includes blood pressure
reading, heart rate, breathing rate and temperature
completing  the  interviews  explained  in  the  description  section  of  this
consent.

Why is your protected health information being used?
Your personal contact information is important to be able to contact you
during the study. Your health information and the results of any tests and
procedures being collected as part of this research study will be used for the
purpose of this study as explained earlier in this consent form. The results of
this study could be published or presented at scientific meetings, lectures, or
other events, but would not include any information that would let others
know who you are, unless you give separate permission to do so.
Who, outside Mount Sinai, might receive your protected health information?
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THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Mount Sinai St. Luke’s, Mount Sinai West 
Page 10 of 14
Study ID #: 18-00381
Form Version Date: 05/11/2018
As part of the study, the Principal Investigator, study team and others in the
Mount Sinai workforce may disclose your protected health information, including
the results of the research study tests and procedures, to the following people
or organizations: (It is possible that there may be changes to the list during this
research study; you may request an up-to-date list at any time by contacting the
Principal Investigator.)
-
A Data Safety Monitoring Board or other committee that will monitor the
study on an ongoing basis for safety.
In all disclosures outside of Mount Sinai, you will not be identified by  name,
social security number, address, telephone number, or any other direct personal
identifier unless disclosure of the direct identifier is required by law. Some
records and information disclosed may be identified with a unique code number.
The Principal Investigator will ensure that the key to the code will be kept in a
locked file, or will be securely stored electronically. The code will not be used to
link the information back to you without your permission, unless the law requires
it, or rarely if the Institutional Review Board allows it after determining that there
would be minimal risk to your privacy. It is possible that a sponsor or their
representatives, a data coordinating office, a contract research organization,
may come to inspect your records. Even if those records are identifiable when
inspected,  the  information  leaving  the  institution  will  be  stripped  of  direct
identifiers.  Additionally, when applicable, the monitors, auditors, the IRB, the
Office of Human Subjects Protection (OHRP) of the Department of Health and
Human Services as well as the Food and Drug Administration (FDA) will be
granted direct access to your medical records for verification of the research
procedures and data. OHRP and FDA are authorized to remove information
with identifiers if necessary to complete their task. By signing this document you
are  authorizing  this  access. We  may  publish  the  results  of  this  research.
However, we will keep your name and other identifying information confidential.
For how long will Mount Sinai be able to use or disclose your protected health
information?
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THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Mount Sinai St. Luke’s, Mount Sinai West 
Page 11 of 14
Study ID #: 18-00381
Form Version Date: 05/11/2018
Your authorization for use of your protected health information for this specific
study does not expire.
Will you be able to access your records?
During your participation in this study, you will not be able to access your
medical records. This will be done to prevent the knowledge of study results
from affecting the reliability of the study. Your information will be available
should an emergency arise that would require your treating physician to know
this information to best treat you. You will have access to your medical record
and any study information that is part of that record when the study is over or
earlier, if possible. The investigator is not required to release to you research
information that is not part of your medical record.
Do  you  need  to  give  us  permission  to  obtain,  use  or  share  your  health
information?
NO! If you decide not to let us obtain, use or share your health information you
should not sign this form, and you  will not be allowed  to volunteer in the
research study. If you do not sign, it will not affect your treatment, payment or
enrollment in any health plans or affect your eligibility for benefits.
Can you change your mind?
You may withdraw your permission for the use and disclosure of any of your
protected information for research, but you must do so in writing to the Principal
Investigator  at  the  address  on  the  first  page.  Even  if  you  withdraw  your
permission, the Principal Investigator for the research study may still use your
protected information that was already collected if that information is necessary
to complete the study. Your health information may still be used or shared after
you withdraw your authorization if you should have an adverse event (a bad
effect) from being in the study. If you withdraw your permission to use your
protected health information for research that means you will also be withdrawn
from the research study, but standard medical care and any other benefits to
which you are entitled will not be affected. You can also tell us you want to
withdraw  from  the  research  study  at  any  time  without  canceling  the
Authorization to use your data.
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THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Mount Sinai St. Luke’s, Mount Sinai West 
Page 12 of 14
Study ID #: 18-00381
Form Version Date: 05/11/2018
If you have not already received it, you will also be given The Hospital’s Notice
of Privacy Practices that contains more information about how The Hospital
uses and discloses your protected health information.
It is important for you to understand that once information is disclosed to others
outside Mount Sinai, the information may be re-disclosed and will no longer be
covered by the federal privacy protection regulations. However, even if your
information will no longer be protected by federal regulations, where possible,
Mount Sinai has entered into agreements with those who will receive your
information to continue to protect your confidentiality.
If as part of this research project your medical records are being reviewed, or a
medical history is being taken, it is possible that HIV-related information may be
revealed to  the  researchers.  If  that  is the case, the following  information
concerns you.  If this research does not involve any review of medical records
or questions about your medical history or conditions, then the following section
may be ignored.  
_______________________________________________________________
__________________
Notice Concerning HIV-Related Information
If you are authorizing the release of HIV-related information, you should be
aware that the recipient(s) is (are) prohibited from re-disclosing any HIV-related
information without your authorization unless permitted to do so under federal or
state law.  You also have a right to request a list of people who may receive or
use  your  HIV-related  information  without  authorization.   If  you  experience
discrimination because of the release or disclosure of HIV-related information,
you may contact the New York State Division of Human Rights at (888) 392-
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Icahn School of Medicine at Mount Sinai
Protocol: IRB-18-00381
Approved: 06/26/2018
Expires: 06/04/2019


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CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Mount Sinai St. Luke’s, Mount Sinai West 
Page 13 of 14
Study ID #: 18-00381
Form Version Date: 05/11/2018
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---------------------------------------------------------FOR IRB USE ONLY--------------------------------------------------------------
Rev6.22.16
Icahn School of Medicine at Mount Sinai
Protocol: IRB-18-00381
Approved: 06/26/2018
Expires: 06/04/2019


THE MOUNT SINAI HEALTH SYSTEM
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION
Mount Sinai St. Luke’s, Mount Sinai West 
Page 14 of 14
Study ID #: 18-00381
Form Version Date: 05/11/2018
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---------------------------------------------------------FOR IRB USE ONLY--------------------------------------------------------------
Rev6.22.16
Icahn School of Medicine at Mount Sinai
Protocol: IRB-18-00381
Approved: 06/26/2018
Expires: 06/04/2019

Prot_000.pdf: 
Quadratus Lumborum II Block vs Conventional Therapy Alone For 
Laparoscopic Sleeve Gastrectomy
PI: Ali Nama Shariat, MD
NCT04073056
Document Date: 1-10-2018


Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816
RISHI KADAKIA MD
RISHI.KADAKIA@MOUNTSINAI.ORG
408-679-1813
JONATHAN EPSTEIN MD
MALIKAH LATMORE MD
HIMANI BHATT DO
KOJI PARK MD
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
1 
Revised  9/2/14 
MSSM Protocol Template HRP-503a 
Instructions: 
1. Prepare a document with the following sections. Note that, depending on the nature of your research,
certain sections below may not be applicable. Indicate N/A as appropriate, explaining where possible.
2. For any items described in the sponsor’s protocol, grant application or other source documents
submitted with the application, you may reference the title and page numbers of these documents rather
than cutting and pasting into this document. Do NOT refer to any derived documents, such as the
Sample Consent document, or other internal documents required with the submission.
3. If you reference page numbers, attach those pages to this protocol.
4. When you write a protocol, keep an electronic copy. You will need to modify this copy when making
changes.
Brief Summary of Research (250-400 words): 
The QL 2 block is a novel fascial plane block recently described by 
Blanco and colleagues in which local anesthetic is deposited adjacent 
to the antero-lateral aspect of the quadratus lumburum muscle. This 
results in posterior spread of local anesthetic through the middle layer 
of the thoraco-lumbar fascia, which theoretically communicates with 
the paravertebral space resulting in potentially longer-lasting and 
denser analgesia than wound infiltration.4 The QL 2 block derives 
from the TAP block, which is also a fascial plane block that is 
commonly used to treat pain following surgery involving the anterior 
abdominal wall. However, the QL block’s more posterior location has 
recently been shown to provide a longer lasting and more profound 
analgesic effect than the TAP block, possibly by communicating with 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
2 
Revised  9/2/14 
the paravertebral space.5 Although the TAP has been shown to be 
effective in a variety of surgical procedures involving an anterior 
abdominal wall incision including laparoscopic bariatric surgery6,7,8 
the QL 2 block has until now, not been studied in the context of 
bariatric surgery. 
 
 
 
 
1) Objectives: 
Research Question: 
     Is the quadratus lumborum (QL) II block superior to conventional therapy 
consisting of wound infiltration with bupivacaine 0.25%, for postoperative 
analgesia following laparoscopic gastric sleeve gastrectomy? 
 
Primary outcome:  
The amount of opioid consumption (in mg IV morphine equivalents)  
during the first 48 hours after the procedure.  
 
Secondary outcomes: 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
3 
Revised  9/2/14 
VAS pain scores on arrival to PACU and at 1, 2, 24, and 48 hours. 
Extent of blockade as determined by pin prick, itching, nausea, 
vomiting in PACU. 
Respiratory rate, heart rate, and blood pressure on arrival, 1 hour after 
arrival to PACU and departure from PACU. 
Time to first dose of opioid administration in the PACU, as well as 
location and type (visceral or somatic) of pain. 
 
 
    2)Background 
The QL 2 block is a novel fascial plane block recently described by 
Blanco and colleagues in which local anesthetic is deposited adjacent to 
the antero-lateral aspect of the quadratus lumborum muscle. This results 
in posterior spread of local anesthetic through the middle layer of the 
thoraco-lumbar fascia, which theoretically communicates with the 
paravertebral space resulting in potentially longer-lasting and denser 
analgesia than wound infiltration.4 Like the more commonly used 
transversus abdominis plane (TAP) block, the QL 2 block targets the 
anterior rami of T7-T12, ilioinguinal, iliohypogastric, and the lateral 
cutaneous branches of L1-L3. The QL 2 block derives from the TAP 
block, which is also a fascial plane block that is commonly used to treat 
pain following surgery involving the anterior abdominal wall. However, 
the QL block’s more posterior location has recently been shown to 
provide a longer lasting and more profound analgesic effect than the TAP 
block, possibly by communicating with the paravertebral space.5 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
4 
Revised  9/2/14 
Although the TAP has been shown to be effective in a variety of surgical 
procedures involving an anterior abdominal wall incision including 
laparoscopic bariatric surgery6,7,8 the QL 2 block has until now, not been 
studied in the context of bariatric surgery. Conventional therapy has 
consisted of surgical infiltration of the incision ports with bupivacaine 
0.25%. We propose a study to compare the analgesic effects of the QL 2 
block with conventional therapy, consisting of surgical wound 
infiltration, for postoperative analgesia following laparoscopic gastric 
sleeve gastrectomy.  
References: 
1. King WC, Chen J-Y, Belle SH, et al.; Use of 
Prescribed Opioids Before and After Bariatric 
Surgery: Prospective Evidence from a U.S. 
Multicenter Cohort Study Surg Obes Relat Dis 
2017; 13: 1337-1346. 
2. Halliday TA, Sundquist J, Hultin M, et al.; 
Post-operative nausea and vomiting in Bariatric 
Surgery Patients: an Observational Study ACTA 
Anaesthesiol Scand 2017; 61: 471-479. 
3. Zarembra S, Shin CH, Hutter MM, et al.; 
Continuous Positive Airway Pressure Mitigates 
Opioid-induced Worsening of Sleep-disordered 
Breathing Early after Bariatric Surgery 
Anesthesiology 2016; 125: 92-104. 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
5 
Revised  9/2/14 
4. Blanco R, McDonnell. Optimal Point of 
Injection: The Quadratus Lumborum Type I 
and II Blocks. Available at: 
http://www.respond2 
articles.com/ANA/forums/post/1550.aspx. 
5. Blanco R, Anasari T, Riad W, Shetty N. 
Quadratus Lumborum Block Versus 
Transversus Abdominis Plane Block for 
Postoperative Pain After Cesarian Delivery. 
Reg Anesth Pain Med 2016; 41: 757-762. 
6. Wassef M, Lee DY, Levine JL, et al. Feasibility 
and Analgesic Efficacy of the Transversus 
Abdominis Plane Block After Single-Port 
Laparoscopy in Patients Having Bariatric 
Surgery. J Pain Res 2013; 6: 837-841. 
7. Sinha A Jayaraman L, Punhani D. Efficacy of 
Ultrasound-Guided Transversus Abdominis 
Plane Block After Laparoscopic Bariatric 
Surgery: a Double-Blind, Randomized, 
Controlled Study. Obes Surg 2013; 23: 548-
553. 
8. Albrecht E, Kirkham KR, Endersby RVW, et 
al. Ultrasound-Guided Transversus Abdominis 
Plane (TAP) Block for Laparoscopic Gastric-
Bypass Surgery: a Prospective Randomized 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
6 
Revised  9/2/14 
Controlled Double-Blinded Trial. Obes Surg 
2013; 23: 1309-1314. 
 
3)Setting of the Human Research 
This is a prospective, double blind, randomized control trial in 
patients undergoing sleeve gastrectomy surgeries. The research 
study will take place at Mount Sinai St. Luke’s hospital. The PI is 
Ali Shariat, MD. 
 
4)Resources Available to Conduct the Human Research 
For n=110, the feasibility of recruitment is manageable as we 
perform 5-10 sleeve gastrectomies per week on average. 
Recruitment will be done through a coordination of the operating 
schedule and the surgeon’s office.  Patients presenting for 
preoperative visits at the preoperative testing clinic will be 
approached. Patients routinely are seen by anesthesiologists at the 
preoperative testing clinic as part of their anesthetic evaluation. 
Patients will be approached by research personnel only if the 
patients are agreeable to the study and details of the study will be 
explained. The consent will be obtained in the pre operative testing 
clinic or in the pre operative holding area after all questions are 
thoroughly answered. The staff members on this protocol are all 
employees of Mount Sinai and will either be a resident or attending 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
7 
Revised  9/2/14 
physicians that are included on the IRB protocol. There are seven 
primary members of the research personnel: 
     a) Ali Shariat, MD. – Roles for Dr. Shariat in this study include 
serving as primary investigator responsible for study design and 
planning, data collection, subject recruitment, manuscript writing 
and preparation, data analysis, safety monitoring, and responding 
to adverse events and/or complications. He is certified in 
PPHS/IRB protocols, all Citi/IRB required training in human 
subject protection, and has prior clinical research experience. He is 
also a board certified anesthesiologist and assistant professor of 
anesthesiology with the Icahn School of Medicine and the Mount 
Sinai Health System. 
     b) Poonam Pai B.H MD – Roles for Dr. Pai include serving as 
primary co-investigator involved in data collection, subject 
recruitment, manuscript writing and preparation, data analysis, 
safety monitoring, and responding to adverse events and/or 
complications.  She has completed all of her required CITI training 
to be IRB certified and has experience in clinical research. In 
addition, she has been a resident physician in anesthesiology with 
the Icahn School of Medicine in good standing for the previous 
three years going on her fourth. 
 
    c)Rishi Kadakia MD – Roles for Dr. Kadakia include serving as 
primary co-investigator involved in data collection, subject 
recruitment, manuscript writing and preparation, data analysis, 
safety monitoring, and responding to adverse events and/or 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
8 
Revised  9/2/14 
complications.  She has completed all of her required CITI training 
to be IRB certified and has experience in clinical research. In 
addition, he has been a resident physician in anesthesiology with 
the Icahn School of Medicine in good standing for the previous 
two years going on his third. 
 
    d)Jonathan Epstein, MD. – Roles for Dr. Epstein in this study 
include serving as co investigator     responsible for study design 
and planning, data collection, subject recruitment, manuscript 
writing and preparation, data analysis, safety monitoring, and 
responding to adverse events and/or complications. He is certified 
in PPHS/IRB protocols, all Citi/IRB required training in human 
subject protection, and has prior clinical research experience. He is 
also a board certified anesthesiologist and assistant professor of 
anesthesiology with the Icahn School of Medicine and the Mount 
Sinai Health System. 
 
    e) Malikah Latmore, MD. – Roles for Dr. Latmore in this study 
include serving as co investigator     responsible for study design 
and planning, data collection, subject recruitment, manuscript 
writing and preparation, data analysis, safety monitoring, and 
responding to adverse events and/or complications. She is certified 
in PPHS/IRB protocols, all Citi/IRB required training in human 
subject protection, and has prior clinical research experience. She 
is also a board certified anesthesiologist and assistant professor of 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
9 
Revised  9/2/14 
anesthesiology with the Icahn School of Medicine and the Mount 
Sinai Health System. 
 
   f) Himani Bhatt, DO. – Roles for Dr. Bhatt in this study include 
serving as co investigator     responsible for study design and 
planning, data collection, subject recruitment, manuscript writing 
and preparation, data analysis, safety monitoring, and responding 
to adverse events and/or complications. She is certified in 
PPHS/IRB protocols, all Citi/IRB required training in human 
subject protection, and has prior clinical research experience. She 
is also a board certified anesthesiologist and assistant professor of 
anesthesiology with the Icahn School of Medicine and the Mount 
Sinai Health System. 
   g) Koji Park MD. – Roles for Dr. Park in this study include 
serving as co investigator     responsible for study design and 
planning, data collection, subject recruitment, manuscript writing 
and preparation, data analysis, safety monitoring, and responding 
to adverse events and/or complications. He is certified in 
PPHS/IRB protocols, all Citi/IRB required training in human 
subject protection, and has prior clinical research experience. He is 
also a board certified bariatric surgeon and assistant professor of 
anesthesiology with the Icahn School of Medicine and the Mount 
Sinai Health System. 
 
 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
10 
Revised  9/2/14 
There are institutional processes to ensure that all persons assisting 
with the protocol will be well informed.  The research personnel 
will conduct regular meetings and department email updates to 
review the results and safety data of the study.  The research 
personnel will initiate the formation of a safety monitoring board 
for adverse effects, complications, or complaints from patient 
subjects. 
 
 
     5)Study Design 
b) Recruitment Methods 
 
This project will be a prospective double blinded randomized control 
trial. 
Recruitment will be done through a coordination of the operating 
schedule and the offices of bariatric surgeons who have agreed to 
allow us to approach their patients regarding recruitment for the study.  
Patients presenting for preoperative visits at the preoperative testing 
clinic at St. Luke’s Hospital will be approached. Patients routinely are 
seen by anesthesiologists at the pre operative testing clinic as part of 
pre operative anesthetic evaluation. Patients will be approached by 
research personnel only if the patients are agreeable to the study and 
details of the study will be explained. The consent will be obtained in 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
11 
Revised  9/2/14 
the pre-operative testing clinic or in the pre operative holding area 
after all questions are thoroughly answered. 
Patients who meet the inclusion criteria will be recruited. The team 
will finalize participation and ask the subject to sign the study consent 
forms.  All patients will be provided with copies of the IRB protocol 
and consent if they wish to have it. Copy of the consent form will be 
sent in a secured email to the potential subject. The email will be 
secured by entering in [SECURE] in the e-mail subject line. Once 
recruited blinding assessments will be done by the study team.  
Patients will be assigned randomly using a computer- generated table 
of numbers to either QL 2 block (QL group) or wound infiltration 
(conventional therapy group). The anesthesia team will perform all 
blocks. The resident anesthesiologist will know the group allocation 
but will not be involved in the study. Conventional therapy consists of 
the injection of 30 mL of bupivacaine 0.25% directly into the incision 
sites by the surgeon at the end of the procedure. 
The QL 2 group will receive 15 mL bupivacaine 0.25% on both sides for a 
total of 30 mL once the surgery is done but prior to extubation. 
Then anesthesiologist performing the QL 2 block will be different from the 
anesthesiologist assessing the patient after surgery. 
The patient and anesthesiologist assessing the patient will be blinded.   
 
 
 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
12 
Revised  9/2/14 
 
 
b) Inclusion and Exclusion Criteria 
Inclusion criteria: patients scheduled to undergo laparoscopic gastric sleeve 
gastrectomy, from 18-65 years of age, with a BMI> 35 kg/m2. 
 
Exclusion criteria: contraindications to administration of local anesthesia 
(e.g. local anesthetic allergy), as well as a contraindication/allergy to 
acetaminophen or ketorolac, and history of substance abuse or chronic 
opioid use, coagulopathy, patients receiving systemic anticoagulation, local 
infection, and ASA 4. 
 
c)Number of Subjects 
110 
The sample size was determined by a priori power analysis, two-
tailed, with effect size of 0.7 (mild-moderate effect), alpha error 0.05, 
power 0.95. 
 
 
d)Study Timelines 
One year 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
13 
Revised  9/2/14 
2018-2019 and subsequent data analysis. The subject’s participation will be 
from time of enrollment in the pre-operative period until first 48 hours after 
surgery. Estimated date of enrollment completion will be when 110 eligible 
subjects are enrolled in final data analysis.  Estimate date for study 
completion will be 2019. 
 
e) Study Endpoints 
Primary outcome: The amount of opioid consumption (in mg IV 
morphine equivalents) postoperatively during the first 48 hours after 
the procedure.  
Secondary outcome: VAS pain scores on arrival to PACU and at 1, 2, 
24, and 48 hours. VAS scores on ambulation on the floors. Extent of 
blockade as determined by pin prick, itching, nausea, vomiting in 
PACU. 
Respiratory rate, heart rate, and blood pressure will be recorded on 
arrival, 1 hour after arrival to PACU and then on departure from 
PACU. 
Time to first dose of opioid administration, PACU length of stay, 
location of pain. 
 
 
 
f) Procedures Involved in the Human Research 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
14 
Revised  9/2/14 
Patients will be randomized to receive either QL 2 block or 
standard therapy, which consists of the injection of 30 mL of 
bupivacaine 0.25% directly into the incision site by the surgeon 
at the end of the procedure. The QL 2 group will receive 15 mL 
bupivacaine 0.25% on both sides for a total of 30 mL.  
All patients will receive general anesthesia (GA) with an 
endotracheal tube. Patients will be brought to the operating 
room and general anesthesia will be induced with midazolam 1-
2 mg, fentanyl 1-2 mcg/kg, propofol 2-3 mg/kg, and 
succinylcholine 0.6 mg/kg followed by intubation of the 
trachea. 
For the QL 2 group, after the surgical procedure is finished and 
before extubation, the abdomen will be sterilized with 
chlorhexidine prep and time out performed according to 
universal protocol. A curved, low frequency probe (5-8 MHz) 
with an imaging depth set between 1-9 cm will be used. For the 
QL 2 block, the probe will be placed at the anterior superior 
iliac spine at the level of the mid-axillary line and moved 
cranially until the three muscles of the abdominal wall: external 
oblique, internal oblique, and transversus abdominis (from 
superficial to deep) are identified. The probe will then be 
moved postero-laterally until the posterior border of the 
external oblique is visualized. At this point, the internal oblique 
forms a roof over the quadratus lumborum and the middle layer 
of the thoracolumbar fascia can then be visualized as a 
hyperechoic band investing the quadratus lumborum muscle. A 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
15 
Revised  9/2/14 
10 cm, 21-gauge block needle will be inserted from an anterior 
to posterior direction followed by injection of 15 mL of 
bupivacaine 0.25% on each side for a total of 30 mL. 
All patients will receive IV acetaminophen 1000 mg and IV 
ketorolac 30 mg, as well as, fentanyl 25-50 mcg prn for 
intraoperative pain when the HR and/or SBP increase to above 
20% of baseline. Postoperatively, all patients will receive 
acetaminophen 1000 mg IV q6h for a total of 4 doses, ketorolac 
15 mg 15 mg IV q6h for a total of 4 doses, and hydromorphone 
0.3 mg IV q4h prn for severe pain (>6 on the VAS pain scale). 
Patients will be evaluated by research personnel who are 
blinded as to which treatment the patient received. The first 
evaluation will be on arrival and one hour after arrival in the 
PACU. This will consist of sensory exam by pinprick to 
determine the extent of the block, VAS pain scores, opioid 
consumption, assessment of nausea and/or vomiting, and 
documentation of vital signs like respiratory rate, heart rate, and 
blood pressure will be recorded in PACU as well. 
 
g) Specimen Banking 
There will be no specimens collected in this study. 
 
h) Data Management and Confidentiality 
 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
16 
Revised  9/2/14 
Data will be stored in a locked cabinet in the Anesthesia offices at 
Mount Sinai St. Luke’s Hospital. 
The patients’ MRN numbers will be matched to the study number in 
an encrypted database on shared drives which will be located solely 
on the Mount Sinai Network computers to ensure protection of 
Protected Health Information. Study data will be stored in a separate 
encrypted database with subject data linked to study number. 
The information included in the data will be medical record number, 
age, gender, time to first narcotic, total narcotic use, pain scores 
during the first 48 hours after surgery. Extent of blockade as 
determined by pin prick, itching, nausea, vomiting, and respiratory 
rate, heart rate, and blood pressure will be recorded on arrival, 1 hour 
after arrival to PACU and then on departure from PACU. PACU 
length of stay, location of pain. 
 
 Only the research personnel will have access to the data. The data 
will be stored as a hard copy files and on a secure database. The 
research personnel are responsible for the receipt of the data. The PI 
will keep the hard copies secure and any electronic data will be 
encrypted. No personal identifiers will be used. The data will undergo 
statistical analysis. 
 
 
 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
17 
Revised  9/2/14 
i)Provisions to Monitor the Data to Ensure the Safety of subjects 
Subjects will be monitored to detect complications our study protocol. 
If complications from the QL 2 block are detected or it is ascertained 
that that the infiltration group is doing significantly better than the QL 
2 group, we will reassess whether or not it is ethical to randomize the 
patient pool.  
Subjects will be informed that they can ask questions or review or 
discuss information pertaining to the study at any time before or 
during the consent process, as well as, during or after the intervention. 
 
Subjects will be approached in the preadmission testing clinic at 
Mount Sinai-St. Luke’s Hospital prior to the day of surgery. The 
patient’s treatment team will continue to provide their standard care 
without interruption, regardless of whether or not the patient 
participates in the study, and regardless of group assignment. 
 
Patients who wish to discuss the study in a private area will have that 
option available to them. 
       Part I: Elements of Data and Safety Monitoring Plan 
MSSM Principal Monitor: 
 
Last Name: Shariat 
First Name: Ali 
Academic Title: Attending Physician, Assistant Professor 
Department: Anesthesiology 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
18 
Revised  9/2/14 
Mailing Address: Mount Sinai St Luke’s 1111, Amsterdam avenue, New York, 
NY 10025 
Phone: 212-523-4000 
Fax:  
E-mail: alinima.shariat@mountsinai.org 
 
 
MSSM Additional Monitor: 
 
Last Name: Pai B.H 
First Name: Poonam 
Academic Title: Research Personnel, Physician 
Department: Anesthesiology 
Mailing Address: Mount Sinai St Luke’s 1111, Amsterdam avenue, New York, 
NY 10025 
Phone: 212-523-4000 
Fax:  
E-mail: phebbalasankatte@chpnet.org 
 
Last Name: Kadakia 
First Name: Rishi 
Academic Title: Research Personnel, Physician 
Department: Anesthesiology 
Mailing Address: Mount Sinai St Luke’s 1111, Amsterdam avenue, New York, 
NY 10025 
Phone: 212-523-4000 
Fax:  
E-mail:Rishi.kadakia@mountsinai.org 
 
Last Name: Epstein 
First Name: Jonathan 
Academic Title: Attending Physician, Assistant Professor 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
19 
Revised  9/2/14 
Department: Anesthesiology 
Mailing Address: Mount Sinai St Luke’s 1111, Amsterdam avenue, New York, 
NY 10025 
Phone: 212-523-4000 
Fax:  
E-mail: jonathan.epstein@mountsinai.org 
 
 
Last Name: Latmore 
First Name: Malikah 
Academic Title: Attending Physician, Assistant Professor 
Department: Anesthesiology 
Mailing Address: Mount Sinai St Luke’s 1111, Amsterdam avenue, New York, 
NY 10025 
Phone: 212-523-4000 
Fax:  
E-mail: malikah.latmore@mountsinai.org 
 
 
Last Name: Bhatt 
First Name: Himani 
Academic Title: Attending Physician, Assistant Professor 
Department: Anesthesiology 
Mailing Address: Mount Sinai St Luke’s 1111, Amsterdam avenue, New York, 
NY 10025 
Phone: 212-523-4000 
Fax:  
E-mail: himani.bhatt@mountsinai.org 
 
 
Last Name: Park 
First Name: Koji 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
20 
Revised  9/2/14 
Academic Title: Attending Physician, Assistant Professor 
Department: Anesthesiology 
Mailing Address: Mount Sinai St Luke’s 1111, Amsterdam avenue, New York, 
NY 10025 
Phone: 212-523-4000 
Fax:  
E-mail: koji.park@mountsinai.org 
 
Adverse events will be monitored as a standard of care everyone 
receives regardless of participation in the study. The safety and data 
information will be reviewed on a daily basis until the desired sample 
size is achieved. All temporary and/or permanent suspensions will be 
reported.  
 
 
 
j) Withdrawal of Subjects 
Patients are free at any time to withdraw from the study. If they do 
so, their information will not be included in the study. 
 
 
 
6)Risks to Subjects 
Systemic absorption or intravascular injection of 0.25% 
bupivacaine or any other preparation of amide local anesthetics 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
21 
Revised  9/2/14 
can result in both central nervous system (CNS) and cardiac 
toxicity. Signs of CNS toxicity include restlessness, anxiety, 
dizziness, tinnitus, blurred vision, or tremors leading to 
convulsions. Such signs of CNS toxicity cannot be detected 
when the patient is under general anesthesia. Signs of cardiac 
toxicity include atrioventricular block, ventricular arrhythmias, 
and cardiac arrest. Patients will be monitored continuously 
during and after the procedure and will be given immediate 
treatment for local anesthetic toxicity if they exhibit the signs. 
Furthermore, the injection is performed in a relatively avascular 
anatomical space and both intravascular injection and systemic 
absorption are relatively unlikely.  
Misplacement of the needle into the peritoneum and/or bowel is 
possible. Ultrasound guidance will be used and if the proper 
visualization of the needle is not possible, the procedure will be 
discontinued. 
Bruising at the site of injection is possible.  
7)Provisions for Research Related Injury 
If subjects have an adverse reaction as a result of participation in 
the study, they will be given treatment and follow up for the 
adverse event at Mount Sinai St. Luke’s Hospital free of charge. 
 
 
8)Potential Benefits to Subjects 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
22 
Revised  9/2/14 
Benefits of QL 2 block in the context of bariatric surgery are 
unknown. Possible benefits that have been described in the 
literature include improved quality and duration of analgesia, 
reduced opioid consumption, reduced incidence of nausea and 
vomiting, and reduced incidence of constipation. There may not be 
any benefits. 
 
 
9)Provisions to Protect the Privacy Interests of Subjects 
Patients will be reassured that any identifying information will not 
be released. The patient’s name, medical record number or any 
other information that identifies a patient will not be included in 
any data analysis. Patients will be contacted by phone from the 
research office at Mount Sinai St. Luke’s Hospital.  
 
 
10Economic Impact on Subjects 
Patients will not incur any additional costs as the QL 2 block is a widely 
used method of analgesia for laparoscopic surgery. 
 
11)Payment to Subjects 
Patients will not receive compensation for this project. 
 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
23 
Revised  9/2/14 
12)Consent Process 
Whenever possible, patients will be introduced to the study during 
their visit to the preoperative assessment clinic several days before 
the date of their operation by the PI, sub-investigators, or other 
members of the research team. When this is not possible, 
recruitment for the study will occur when patients are assessed in 
the holding area on the day of surgery. Neither children nor 
cognitively impaired patients, as determined by ability to consent 
to the procedure, will be recruited.  
 
 
13)Process to Document Consent in Writing 
The standardized IRB consent template will be used. 
 
 
14)Vulnerable Populations 
Not applicable. 
 
 
15)Multi-Site Human Research (Coordinating Center) 
Not applicable. 
 


 
Protocol Title: 
QUADRATUS LUMBORUM II BLOCK VS 
CONVENTIONAL THERAPY ALONE FOR 
LAPAROSCOPIC SLEEVE GASTRECTOMY 
Principal Investigator 
Name/Contact Info:  
ALI SHARIAT MD 
ALINIMA.SHARIAT@MOUNTSINAI.ORG 
Primary Contact 
Name/Contact Info 
POONAM PAI B.H MD  
PHEBBALASANKATTE@CHPNET.ORG 
347-569-4816 
RISHI KADAKIA MD 
RISHI.KADAKIA@MOUNTSINAI.ORG 
408-679-1813 
JONATHAN EPSTEIN MD 
MALIKAH LATMORE MD 
HIMANI BHATT DO 
KOJI PARK MD 
Date Revised: 
1/10/2018 
Study Number: 
IF 2203362 
 
24 
Revised  9/2/14 
 
16)Community-Based Participatory Research 
Not applicable. 
 
 
17)Sharing of Results with Subjects 
Results will not be shared with the subjects. 
 
 
18)External IRB Review History 
Not applicable. 
 
 
19)Control of Drugs, Biologics, or Devices 
Note: The IDS has its own forms that must be completed and a review process 
that must be followed before the IDS representative will sign off on Appendix B 
for submission to the PPHS. 
Not applicable.