Quadratus Lumborum II Block vs Conventional Therapy Alone For Laparoscopic Sleeve Gastrectomy
Phase: PHASE4
Conditions: Morbid Obesity, High BMI
Sponsor: Icahn School of Medicine at Mount Sinai

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 
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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.