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Phase 4 N=40 Randomized Triple-blind Treatment

Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

Morbid Obesity · High BMI

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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