NCT04073056

Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

Completed Phase 4 Results posted Last updated 5 January 2023

What this trial tests

Phase 4 trial testing Bupivacaine in Morbid Obesity in 41 participants. Completed in 23 February 2021.

Timeline

1 August 2018

Primary endpoint
23 February 2021

23 February 2021

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	41
Start date	1 August 2018
Primary completion	23 February 2021
Estimated completion	23 February 2021
Sites	1 location across United States

Drugs / interventions tested

• Bupivacaine (BUPIVACAINE) — full drug profile →

Conditions studied

• Morbid Obesity — all drugs for Morbid Obesity →
• High BMI — all drugs for High BMI →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

Adults 18 to 65, any sex, with Morbid Obesity or High BMI. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Amount of Opioid Consumption During and After Procedure Primary · 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)

Intraop

Group	Value	95% CI
Conventional Therapy	26.3	± 12.4
Quadratus Lumborum II Group	27.1	± 11.9

POQ1 - PACU hour 1

Group	Value	95% CI
Conventional Therapy	5.49	± 3.49
Quadratus Lumborum II Group	5.52	± 3.64

POQ2 - PACU hour 2

Group	Value	95% CI
Conventional Therapy	2.80	± 1.66
Quadratus Lumborum II Group	1.68	± 2.10

POD 0

Group	Value	95% CI
Conventional Therapy	4.14	± 5.12
Quadratus Lumborum II Group	2.53	± 3.16

POD1

Group	Value	95% CI
Conventional Therapy	3.13	± 4.72
Quadratus Lumborum II Group	2.75	± 3.52

POD2

Group	Value	95% CI
Conventional Therapy	0.938	± 1.46
Quadratus Lumborum II Group	0.750	± 1.43

VAS Pain Scores Secondary · Intraop, Postop 1hr, Postop 2hr, POD0, POD1, and POD2

Visual analogue scale - total score from 0 to 10, with higher score indicating more pain

POQ1 - PACU hour 1

Group	Value	95% CI
Conventional Therapy	6.60	± 2.11
Quadratus Lumborum II Group	6.15	± 1.95

POQ2 - PACU hour 2

Group	Value	95% CI
Conventional Therapy	4.37	± 2.27
Quadratus Lumborum II Group	3.11	± 1.59

POD 0

Group	Value	95% CI
Conventional Therapy	5.85	± 2.89
Quadratus Lumborum II Group	4.80	± 2.33

POD1

Group	Value	95% CI
Conventional Therapy	6.20	± 2.71
Quadratus Lumborum II Group	4.05	± 1.96

POD2

Group	Value	95% CI
Conventional Therapy	5.00	± 2.57
Quadratus Lumborum II Group	3.28	± 1.87

Respiratory Rate Secondary · 1 hour post op

Respiratory rate in breaths per minute

Group	Value	95% CI
Conventional Therapy	22.5	± 2.72
Quadratus Lumborum II Group	17.0	± 4.80

Heart Rate Secondary · 1 hour after surgery

Heart rate in beats per minute

Group	Value	95% CI
Conventional Therapy	85.3	± 14.0
Quadratus Lumborum II Group	7.3	± 12.5

Blood Pressure Secondary · 1 hour after surgery

Both systolic and diastolic pressures

Systolic pressure

Group	Value	95% CI
Conventional Therapy	134	± 11.9
Quadratus Lumborum II Group	136	± 15.9

Diastolic

Group	Value	95% CI
Conventional Therapy	80.1	± 11.6
Quadratus Lumborum II Group	83.0	± 10.8

Time to First Dose of Analgesic Request Secondary · up to 60 minutes

Time until first analgesic request in minutes

Group	Value	95% CI
Conventional Therapy	34.0	± 23.9
Quadratus Lumborum II Group	28.1	± 18.4

PACU Length of Stay Secondary · average 2 hours

Post anesthesia care unit (PACU) length of stay in hours

Group	Value	95% CI
Conventional Therapy	2.18	± 0.572
Quadratus Lumborum II Group	1.95	± 0.822

Number of Participants With Pain Secondary · Up to 48 hours

Number of participants with somatic or visceral pain.

Somatic pain

Group	Value	95% CI
Conventional Therapy	3
Quadratus Lumborum II Group	2

Visceral pain

Group	Value	95% CI
Conventional Therapy	18
Quadratus Lumborum II Group	18

Number of Participants With Nausea Secondary · the first 48 hours after the procedure

Number of participants with nausea

POQ2

Group	Value	95% CI
Conventional Therapy	12
Quadratus Lumborum II Group	7

POD1

Group	Value	95% CI
Conventional Therapy	8
Quadratus Lumborum II Group	6

POD2

Group	Value	95% CI
Conventional Therapy	4
Quadratus Lumborum II Group	2

Sponsor's own 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. 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.