Transversus Abdominis Plane (TAP) Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients

Phase 1

Completed

• Conditions: Morbid Obesity; Bariatric Surgery Candidate
• Interventions: Drug: Bupivacaine Injection; Drug: Liposomal bupivacaine

• Registration Number: NCT05537883
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed Description

Compared to only Bupivacaine administered via TAP block, the study will investigate the analgesia effects to patients undergoing metabolic and bariatric surgery receiving TAP block with a Liposomal Bupivacaine mixture. To determine if patients undergoing metabolic and bariatric surgery receiving TAP block with a Liposomal Bupivacaine results in pain scores, as measured by visual analogic scale (VAS), that are equivalent compared to patients receiving TAP block with Bupivacaine only. Compared to TAP block with Bupivacaine only, the study will compare opioid consumption, and other effect differences to patients undergoing metabolic and bariatric surgery receiving TAP block with Liposomal Bupivacaine. The study will explore other effects, including pain score at 48 hours, and 72 hours after surgery, total opioid consumption required post op during their one-week post op visit as measured in morphine equivalences.

Study Timeline

• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-13
• Study Start: 2022-11-29
• Primary Completion: 2023-12-07
• Study Completion: 2023-12-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine only	Bupivacaine Injection	Active control group patients receive Transversus Abdominis Plane (TAP) block with a Bupivacaine only mixture, containing 50 mL 0.5% Bupivacaine, and 100 mL normal saline solution.
Liposomal Bupivacaine	Liposomal bupivacaine	Study group patients will receive Transversus Abdominis Plane (TAP) block with a Liposomal Bupivacaine mixture, containing 20 mL Liposomal Bupivacaine, 30 mL 0.5% Bupivacaine, and 100 mL normal saline solution.

Primary Outcome Measures

Name	Time	Method
24 Hour Visual Analogue Scale (VAS) Pain Score	Hour 24	Pain score at 24 hours post-operative, using visual analogue scale (VAS), ranging from 1 to 10. One indicates no pain, and 10 indicates the worst pain one could imagine.

Secondary Outcome Measures

Name	Time	Method
Morphine Equivalences - Immediate	Hour 24	Morphine milligram equivalences consumed during hospital stay
Length of Hospital Stay	Day 3	Hospital length of stay in hours
Morphine Equivalences - Week 1	Week 1	Morphine milligram equivalences prescribed and consumed as measured at one week follow up clinic visit
Visual Analogue Scale (VAS) Pain Scores	Hours,12, 48, and 72	Pain score at 12 hours, 48 hours, and 72 hours post-operative, using visual analogue scale (VAS), ranging from 1 to 10. One indicates no pain, and 10 indicates the worst pain one could imagine
Post-operative nausea and vomiting (PONV)	Week 1	Post-operative nausea and vomiting (PONV) measured by a numerical score (1: no nausea or vomiting, 2: some nausea no vomiting, 3: nausea and vomiting)
Patient Satisfaction Scores	Day 30	Patient Satisfaction score based on daily postop online surveys - These parameters will be scored via SeamlessMD on a phone application, as well as paper and pen on a standardized reporting form for patients less comfortable using technology - scored on a scale of 0-10, with 0 being "worst surgeon possible and 10 being "best surgeon possible."

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States