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

NCT05537883 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: IRB00083696
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Bariatric Surgery Candidate

Keywords

Transversus Abdominis Plane (TAP) block; Bupivacaine; Liposomal bupivacaine

Outcome Measures

Primary Outcomes (1)

• Mean 24 Hour Visual Analogue Scale (VAS) Pain Score

  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.

  Hour 24

Secondary Outcomes (6)

• Mean Visual Analogue Scale (VAS) Pain Scores

  Hours,12, 48, and 72

• Mean Average Morphine Equivalences

  Day 3

• Morphine Equivalences - Week 1

  Week 1

• Post-operative Nausea and Vomiting (PONV)

  Week 1

• Length of Hospital Stay

  Day 3

Study Arms (2)

Bupivacaine only

ACTIVE COMPARATOR

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.

Drug: Bupivacaine Injection

Liposomal Bupivacaine

EXPERIMENTAL

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.

Drug: Liposomal bupivacaine

Interventions

Liposomal bupivacaine DRUG

Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine

Also known as: Exparel

Liposomal Bupivacaine

Bupivacaine Injection DRUG

Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine

Also known as: Plain bupivacaine

Bupivacaine only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (4)

• McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.

  PMID: 17961838 BACKGROUND

• Mukhtar K, Singh S. Transversus abdominis plane block for laparoscopic surgery. Br J Anaesth. 2009 Jan;102(1):143-4. doi: 10.1093/bja/aen338. No abstract available.

  PMID: 19059927 BACKGROUND

• Hamid HKS, Ahmed AY, Saber AA, Emile SH, Ibrahim M, Ruiz-Tovar J. Transversus abdominis plane block using a short-acting local anesthetic reduces pain and opioid consumption after laparoscopic bariatric surgery: a meta-analysis. Surg Obes Relat Dis. 2020 Sep;16(9):1349-1357. doi: 10.1016/j.soard.2020.04.023. Epub 2020 Apr 24.

  PMID: 32709581 BACKGROUND

• Jin Z, Ding O, Islam A, Li R, Lin J. Comparison of Liposomal Bupivacaine and Conventional Local Anesthetic Agents in Regional Anesthesia: A Systematic Review. Anesth Analg. 2021 Jun 1;132(6):1626-1634. doi: 10.1213/ANE.0000000000005406.

  PMID: 33687173 BACKGROUND

Related Links

• Patient survey app distribution website

MeSH Terms

Conditions

Obesity, Morbid; Bites and Stings

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Selwan Barbat, MD
• Organization: Wake Forest University Health Sciences

Selwan.Barbat@atriumhealth.org

704-355-2000

Study Officials

• Abdelrahman Nimeri, MD

  Wake Forest University Health Sciences, Atrium Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to type of Transversus Abdominis Plane (TAP) block used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a 2-arm parallel single blinded randomized equivalency, single-center, clinical trial.

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 13, 2022
• Study Start: November 29, 2022
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: June 11, 2025
• Results First Posted: June 11, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)