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NCT05537883 · ClinicalTrials.gov registry record · Phase 1
Transversus Abdominis Plane (TAP) Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients
A Phase 1 study of Bariatric Surgery Candidate and Morbid Obesity, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT05537883: Completed Phase 1 study of Bariatric Surgery Candidate and Morbid Obesity, sponsored by Wake Forest University Health Sciences.
NCT05537883 is a Phase 1 study of Bariatric Surgery Candidate and Morbid Obesity that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 72 participants, below the 111-participant average among 28 other Bariatric Surgery Candidate trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05537883, a Phase 1 study of Bariatric Surgery Candidate and Morbid Obesity, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Liposomal bupivacaine
- DRUG Bupivacaine Injection
Study Locations (1)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2022-11-29 |
| Est. Completion | 2023-12-07 |
| Phase | Phase 1 |
What the finished NCT05537883 record still lists
NCT05537883 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 111-participant average among 28 other Bariatric Surgery Candidate trials with a reported enrollment target (35% lower).
The record links to 2 conditions, with Bariatric Surgery Candidate appearing as the primary indexed condition, and to 2 interventions - of which Liposomal bupivacaine is the first listed.
NCT05537883 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05537883 about?
NCT05537883 is a clinical study titled "Transversus Abdominis Plane (TAP) Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients". 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, Morphin...
What is the current status of trial NCT05537883?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2022-11-29. Estimated completion is 2023-12-07.
What conditions does trial NCT05537883 study?
This clinical trial studies the following conditions: Bariatric Surgery Candidate, Morbid Obesity.
What interventions are being tested in trial NCT05537883?
The interventions under investigation include: Liposomal bupivacaine (DRUG), Bupivacaine Injection (DRUG).
Who is sponsoring clinical trial NCT05537883?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05537883 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05537883's enrollment target sits among peer trials
72 12th of 28 higher than 17 of 28 other Bariatric Surgery Candidate trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bariatric Surgery Candidate trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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