Transversus Abdominis Plane (TAP) Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Bupivacaine Injection
Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine
Other Names:
|
| 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. |
Drug: Liposomal bupivacaine
Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Morphine Equivalences - Immediate [Hour 24]
Morphine milligram equivalences consumed during hospital stay
- Morphine Equivalences - Week 1 [Week 1]
Morphine milligram equivalences prescribed and consumed as measured at one week follow up clinic visit
- 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)
- Length of Hospital Stay [Day 3]
Hospital length of stay in hours
- 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."
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age > 18 years
-
Participants who can give written informed consent and willing to comply with all study-related procedures.
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Patients undergoing primary sleeve gastrectomy or roux-en-y gastric bypass
Exclusion Criteria:
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Patients undergoing duodenal switch procedures
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Patients undergoing concomitant hiatal hernia repair or ventral hernia repair or cholecystectomy at time of primary metabolic surgery
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Patients with chronic opioid use
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Abdelrahman Nimeri, MD, Wake Forest University Health Sciences, Atrium Health
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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. Review.
- 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.
- 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.
- 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.
- IRB00083696