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

Overview

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.

Full Title of Study: “Single Blinded Randomized Trial of Transversus Abdominis Plane Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 2024

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.

Interventions

  • Drug: Liposomal bupivacaine
    • Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine
  • Drug: Bupivacaine Injection
    • Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine

Arms, Groups and Cohorts

  • Active Comparator: Bupivacaine only
    • 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.
  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 24 Hour Visual Analogue Scale (VAS) Pain Score
    • Time Frame: 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 Measures

  • Visual Analogue Scale (VAS) Pain Scores
    • Time Frame: 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
  • Morphine Equivalences – Immediate
    • Time Frame: Hour 24
    • Morphine milligram equivalences consumed during hospital stay
  • Morphine Equivalences – Week 1
    • Time Frame: Week 1
    • Morphine milligram equivalences prescribed and consumed as measured at one week follow up clinic visit
  • Post-operative nausea and vomiting (PONV)
    • Time Frame: 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)
  • Length of Hospital Stay
    • Time Frame: Day 3
    • Hospital length of stay in hours
  • Patient Satisfaction Scores
    • Time Frame: 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.”

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wake Forest University Health Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Abdelrahman Nimeri, MD, Principal Investigator, Wake Forest University Health Sciences, Atrium Health
  • Overall Contact(s)
    • Elizabeth A Santone, MD, 203-314-2550, elizabeth.santone@atriumhealth.org

References

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.

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.

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