Transversus Abdominis Plane (TAP) Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients (TAP)
Primary Purpose
Morbid Obesity, Bariatric Surgery Candidate
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Bupivacaine Injection
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring Transversus Abdominis Plane (TAP) block, Bupivacaine, Liposomal bupivacaine
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
Sites / Locations
- Wake Forest University Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Bupivacaine only
Liposomal Bupivacaine
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Visual Analogue Scale (VAS) Pain Scores
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
Morphine milligram equivalences consumed during hospital stay
Morphine Equivalences - Week 1
Morphine milligram equivalences prescribed and consumed as measured at one week follow up clinic visit
Post-operative nausea and vomiting (PONV)
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
Hospital length of stay in hours
Patient Satisfaction Scores
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."
Full Information
NCT ID
NCT05537883
First Posted
September 12, 2022
Last Updated
July 26, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05537883
Brief Title
Transversus Abdominis Plane (TAP) Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients
Acronym
TAP
Official Title
Single Blinded Randomized Trial of Transversus Abdominis Plane Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Bariatric Surgery Candidate
Keywords
Transversus Abdominis Plane (TAP) block, Bupivacaine, Liposomal bupivacaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This study is a 2-arm parallel single blinded randomized equivalency, single-center, clinical trial.
Masking
Participant
Masking Description
Patients will be blinded to type of Transversus Abdominis Plane (TAP) block used.
Allocation
Randomized
Enrollment
212 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine only
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Liposomal Bupivacaine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Other Intervention Name(s)
Plain bupivacaine
Intervention Description
Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine
Primary Outcome Measure Information:
Title
24 Hour Visual Analogue Scale (VAS) Pain Score
Description
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.
Time Frame
Hour 24
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) Pain Scores
Description
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
Time Frame
Hours,12, 48, and 72
Title
Morphine Equivalences - Immediate
Description
Morphine milligram equivalences consumed during hospital stay
Time Frame
Hour 24
Title
Morphine Equivalences - Week 1
Description
Morphine milligram equivalences prescribed and consumed as measured at one week follow up clinic visit
Time Frame
Week 1
Title
Post-operative nausea and vomiting (PONV)
Description
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)
Time Frame
Week 1
Title
Length of Hospital Stay
Description
Hospital length of stay in hours
Time Frame
Day 3
Title
Patient Satisfaction Scores
Description
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."
Time Frame
Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth A Santone, MD
Phone
203-314-2550
Email
elizabeth.santone@atriumhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelrahman Nimeri, MD
Phone
704-355-9484
Email
abdelrahman.nimeri@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdelrahman Nimeri, MD
Organizational Affiliation
Wake Forest University Health Sciences, Atrium Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Santone, MD
Phone
203-314-2550
Email
elizabeth.santone@atriumhealth.org
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17961838
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.
Results Reference
background
PubMed Identifier
19059927
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.
Results Reference
background
PubMed Identifier
32709581
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.
Results Reference
background
PubMed Identifier
33687173
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.
Results Reference
background
Links:
URL
https://seamless.md/
Description
Patient survey app distribution website
Learn more about this trial
Transversus Abdominis Plane (TAP) Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients
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