NCT05537883|CompletedPhase 1ResultsDMCFDA Drug
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TAP
Single Blinded Randomized Trial of Transversus Abdominis Plane Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients
Sponsor study identifier
interventional
72
1 country
1
Study Start
November 29, 2022
Actual (reported)Primary Completion
December 7, 2023
Actual (reported)Study Completion
December 7, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 7, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 12, 2022
Actual (reported)September 13, 2022
Actual (reported)November 29, 2022
Actual (reported)December 7, 2023
Actual (reported)December 7, 2023
Actual (reported)June 11, 2025
Actual (reported)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
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
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.
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.
Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine
Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Liposomal bupivacaine
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Liposomal bupivacaine
Named ingredient: Bupivacaine
View registry recordWake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
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.
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.
Abdelrahman Nimeri, MD
Wake Forest University Health Sciences, Atrium Health
72 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2022
First Posted
September 13, 2022
Study Start
November 29, 2022
The Use Of Liposomal Bupivacaine For Pain Control
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
December 7, 2023
Actual (reported)Study Completion
December 7, 2023
Actual (reported)Last Updated
June 11, 2025
Results First Posted
June 11, 2025
Record last verified: 2024-06
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Source: ClinicalTrials.gov.
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