Phase 4 N=43 Randomized Triple-blind Other

Unilateral TAP Block for Laparoscopic Gastric Sleeve Surgery

Laparoscopic Sleeve Gastrectomy · Subcostal Transversus Abdominis Plane Block

Bottom Line

View on ClinicalTrials.gov: NCT03856788 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2022

Primary outcome: Primary: Amount of 24 Hour Opioid Consumption — 44.7; 38.7 morphine milligram equivalents

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Saline (Drug); Bupivacaine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Icahn School of Medicine at Mount Sinai
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Amount of 24 Hour Opioid Consumption	44.7; 38.7	—
SECONDARY Amount of Intraoperative IV Opioid Consumption	35; 32.5	—
SECONDARY Number of Participants Asked Area of Pain on the Body After Surgery	3; 7; 7; 1; 3; 3	—
SECONDARY Number of Participants Who Answered Yes to Having Presence of Nausea After Surgery	16; 14	—

Summary

The study team will be assessing if the unilateral subcostal transversus abdominis plane (TAP) block can decrease pain and improve outcomes following laparoscopic sleeve gastrectomy surgeries.

Eligibility Criteria

Inclusion Criteria

Adults 18-80 years old
Candidate for general anesthesia
Undergoing laparoscopic sleeve gastrectomy
Patients of participating surgeons

Exclusion Criteria

Prior bariatric surgery of any kind
Previous abdominoplasty
Allergy or intolerance to one of the study medications
ASA > 4
Chronic opioid use (taking opioids for longer than 3 months or daily oral morphine equivalent of >5mg/day for one month)
History of alcohol/drug abuse
History of hepatic or renal insufficiency
Patient refusal

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03856788). 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.