Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

Phase 4

Completed

Conditions: High BMI
Morbid Obesity

Interventions: Drug: Bupivacaine

Registration Number: NCT04073056

Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Therapy	Bupivacaine	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.
Quadratus Lumborum II Group	Bupivacaine	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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