Phase 1
N=69
Transversus Abdominis Plane (TAP) Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients
Morbid Obesity · Bariatric Surgery Candidate
Bottom Line
View on ClinicalTrials.gov: NCT05537883 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Mean 24 Hour Visual Analogue Scale (VAS) Pain Score — 1; 3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Liposomal bupivacaine (Drug); Bupivacaine Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean 24 Hour Visual Analogue Scale (VAS) Pain Score |
1; 3 | — |
| SECONDARY Mean Visual Analogue Scale (VAS) Pain Scores |
4.4; 5.64; 5.7; 5.6; 2.5; 7.0 | — |
| SECONDARY Mean Average Morphine Equivalences |
11.67; 13.1; 4.67; 3.43; 3.8; 5.61 | — |
| SECONDARY Morphine Equivalences - Week 1 |
— | — |
| SECONDARY Post-operative Nausea and Vomiting (PONV) |
— | — |
| SECONDARY Length of Hospital Stay |
24.5; 29.7 | — |
| SECONDARY Patient Satisfaction Scores |
— | — |
Summary
To investigate if laparoscopic Transversus Abdominis Plane (TAP) block using plain bupivacaine is equivalent to using liposomal bupivacaine in patients undergoing metabolic and bariatric surgery. The study will see if the plain bupivacaine group will be equivalent in terms of length of stay, Morphine Milligram Equivalents, Pain scores and patient satisfaction, but cost less.
Eligibility Criteria
Inclusion Criteria
- age > 18 years
- Participants who can give written informed consent and willing to comply with all study-related procedures.
- Patients undergoing primary sleeve gastrectomy or roux-en-y gastric bypass
Exclusion Criteria
- Patients undergoing duodenal switch procedures
- Patients undergoing concomitant hiatal hernia repair or ventral hernia repair or cholecystectomy at time of primary metabolic surgery
- Patients with chronic opioid use
Data sourced from ClinicalTrials.gov (NCT05537883). 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.