Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04073056
• Other study ID #: GCO 18-1004
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2018
• Est. completion date: February 23, 2021

Study information

• Verified date: December 2022
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: February 23, 2021
• Est. primary completion date: February 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• High BMI
• Morbid Obesity
• Obesity, Morbid

Intervention

Drug:
• Bupivacaine
Bupivacaine Hcl 0.25% Inj

Locations

Country	Name	City	State
United States	Mount Sinai St. Lukes Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Respiratory Rate	Respiratory rate in breaths per minute	1 hour post op
Secondary	Heart Rate	Heart rate in beats per minute	1 hour after surgery
Secondary	Blood Pressure	Both systolic and diastolic pressures	1 hour after surgery
Secondary	Time to First Dose of Analgesic Request	Time until first analgesic request in minutes	up to 60 minutes
Secondary	PACU Length of Stay	Post anesthesia care unit (PACU) length of stay in hours	average 2 hours
Secondary	Number of Participants With Pain	Number of participants with somatic or visceral pain.	Up to 48 hours
Secondary	Number of Participants With Nausea	Number of participants with nausea	the first 48 hours after the procedure

External Links

•   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.
•   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.
•   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.