Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

NCT04073056 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: GCO 18-1004
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; High BMI

Keywords

Sleeve gastrectomy; Quadratus lumborum block; Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• VAS Pain Scores

  Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2

• Respiratory Rate

  1 hour post op

• Heart Rate

  1 hour after surgery

• Blood Pressure

  1 hour after surgery

• Time to First Dose of Analgesic Request

  up to 60 minutes

Study Arms (2)

Quadratus Lumborum II Group

ACTIVE COMPARATOR

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

Conventional Therapy

ACTIVE COMPARATOR

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

Interventions

Bupivacaine DRUG

Bupivacaine Hcl 0.25% Inj

Conventional Therapy; Quadratus Lumborum II Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai St. Lukes Hospital

New York, New York, 10025, United States

Location

Related Publications (3)

• 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.

  PMID: 28579202 BACKGROUND

• 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.

  PMID: 27755488 BACKGROUND

• 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.

  PMID: 23591549 BACKGROUND

Related 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.

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Ali Shariat
• Organization: Icahn School of Medicine at Mount Sinai

AliNima.Shariat@mountsinai.org

212-523-2500

Study Officials

• Ali N Shariat

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 28, 2019
• Study Start: August 1, 2018
• Primary Completion: February 23, 2021
• Study Completion: February 23, 2021
• Last Updated: January 5, 2023
• Results First Posted: January 5, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)