Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

Quadratus Lumborum II Block vs Conventional Therapy Alone For Laparoscopic Sleeve Gastrectomy

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity; High BMI
• Intervention / Treatment: Drug: Bupivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10025
      • Mount Sinai St. Lukes Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled to undergo laparoscopic gastric sleeve gastrectomy
• 18-65 years of age
• BMI> 35 kg/m2.

Exclusion Criteria:

• Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
• Contraindication/allergy to acetaminophen or ketorolac
• History of substance abuse or chronic opioid use
• Coagulopathy
• Patients receiving systemic anticoagulation
• Local infection
• ASA 4

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Quadratus Lumborum II Group; 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.	Drug: Bupivacaine; Bupivacaine Hcl 0.25% Inj
Active Comparator: Conventional Therapy; 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.	Drug: Bupivacaine; Bupivacaine Hcl 0.25% Inj

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Amount of Opioid Consumption During and After Procedure	The amount of opioid consumption (in mg IV morphine equivalents) during and after procedure (100mcg fentanyl= 10mg morphine) (1.5mg dilaudid=10mg morphine)	Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Pain Scores	Visual analogue scale - total score from 0 to 10, with higher score indicating more pain	Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2
Respiratory Rate	Respiratory rate in breaths per minute	1 hour post op
Heart Rate	Heart rate in beats per minute	1 hour after surgery
Blood Pressure	Both systolic and diastolic pressures	1 hour after surgery
Time to First Dose of Analgesic Request	Time until first analgesic request in minutes	up to 60 minutes
PACU Length of Stay	Post anesthesia care unit (PACU) length of stay in hours	average 2 hours
Number of Participants With Pain	Number of participants with somatic or visceral pain.	Up to 48 hours
Number of Participants With Nausea	Number of participants with nausea	the first 48 hours after the procedure

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Ali N Shariat, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495. Erratum In: Reg Anesth Pain Med. 2018;43:111.
• King WC, Chen JY, Belle SH, Courcoulas AP, Dakin GF, Flum DR, Hinojosa MW, Kalarchian MA, Mitchell JE, Pories WJ, Spaniolas K, Wolfe BM, Yanovski SZ, Engel SG, Steffen KJ. Use of prescribed opioids before and after bariatric surgery: prospective evidence from a U.S. multicenter cohort study. Surg Obes Relat Dis. 2017 Aug;13(8):1337-1346. doi: 10.1016/j.soard.2017.04.003. Epub 2017 Apr 7.
• Albrecht E, Kirkham KR, Endersby RV, Chan VW, Jackson T, Okrainec A, Penner T, Jin R, Brull R. Ultrasound-guided transversus abdominis plane (TAP) block for laparoscopic gastric-bypass surgery: a prospective randomized controlled double-blinded trial. Obes Surg. 2013 Aug;23(8):1309-14. doi: 10.1007/s11695-013-0958-3.

Helpful Links

• 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.
• Blanco R, Ansari 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.
• Albrecht E, Kirkham KR, Endersby RVW, et al. Ultrasound-Guided Transversus Abdominis Plane (TAP) Block for Laparoscopic Gastric-Bypass Surgery: a Prospective Randomized Controlled Double-Blinded Trial. Obes Surg 2013; 23: 1309-1314.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): February 23, 2021
• Study Completion (Actual): February 23, 2021

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Bariatric surgery; Sleeve gastrectomy; Quadratus lumborum block
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: GCO 18-1004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No