Clinical trial NCT05537883: Transversus Abdominis Plane (TAP) Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients
Official title: Single Blinded Randomized Trial of Transversus Abdominis Plane Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Morbid Obesity
Bariatric Surgery Candidate
Keywords: Transversus Abdominis Plane (TAP) block
Bupivacaine
Liposomal bupivacaine
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a 2-arm parallel single blinded randomized equivalency, single-center, clinical trial.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean 24 Hour Visual Analogue Scale (VAS) Pain Score
timeFrame: Hour 24
Secondary outcomes:
measure: Mean Visual Analogue Scale (VAS) Pain Scores
timeFrame: Hours,12, 48, and 72
measure: Mean Average Morphine Equivalences
timeFrame: Day 3
measure: Morphine Equivalences - Week 1
timeFrame: Week 1
measure: Post-operative Nausea and Vomiting (PONV)
timeFrame: Week 1
measure: Length of Hospital Stay
timeFrame: Day 3
measure: Patient Satisfaction Scores
timeFrame: Day 30
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences, Atrium Health
name: Abdelrahman Nimeri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.