Phase 4
N=40
Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy
Morbid Obesity · High BMI
Bottom Line
View on ClinicalTrials.gov: NCT04073056 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: The Amount of Opioid Consumption During and After Procedure — 26.3; 27.1; 5.49; 5.52 mg IV morphine equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Amount of Opioid Consumption During and After Procedure |
26.3; 27.1; 5.49; 5.52; 2.80; 1.68 | — |
| SECONDARY VAS Pain Scores |
6.60; 6.15; 4.37; 3.11; 5.85; 4.80 | — |
| SECONDARY Respiratory Rate |
22.5; 17.0 | — |
| SECONDARY Heart Rate |
85.3; 7.3 | — |
| SECONDARY Blood Pressure |
134; 136; 80.1; 83.0 | — |
| SECONDARY Time to First Dose of Analgesic Request |
34.0; 28.1 | — |
| SECONDARY PACU Length of Stay |
2.18; 1.95 | — |
| SECONDARY Number of Participants With Pain |
3; 2; 18; 18 | — |
| SECONDARY Number of Participants With Nausea |
12; 7; 8; 6; 4; 2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04073056). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.