A Phase 1 interventional study of Liposomal bupivacaine and Bupivacaine Injection in Morbid Obesity and Bariatric Surgery Candidate, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by Wake Forest University Health Sciences · Phase 1, Interventional, and Treatment
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.
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.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
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
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
Also known as: Exparel
Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine
Also known as: Plain bupivacaine
Mean 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.
Time frame: Hour 24
Mean 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
Time frame: Hours,12, 48, and 72
Mean Average Morphine Equivalences
Morphine milligram equivalences consumed during hospital stay
Time frame: Day 3
Morphine Equivalences - Week 1
Morphine milligram equivalences prescribed and consumed as measured at one week follow up clinic visit
Time frame: Week 1
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)
Time frame: Week 1
Length of Hospital Stay
Hospital length of stay in hours
Time frame: Day 3
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."
Time frame: Day 30
| Milestone | Bupivacaine Only | Liposomal Bupivacaine |
|---|---|---|
| Started | 35 | 34 |
| Completed | 0 | 0 |
| Not completed | 35 | 34 |
| Withdrew: Revisional surgery | 4 | 2 |
| Withdrew: Surgeries were cancelled | 0 | 2 |
| Withdrew: Not being compliant with the seamless md app | 31 | 30 |
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.
| score on a scale | Bupivacaine Only | Liposomal Bupivacaine |
|---|---|---|
| Mean 24 Hour Visual Analogue Scale (VAS) Pain Score | 1 (0 to 5) | 3 (0 to 9) |
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
| score on a scale | Bupivacaine Only | Liposomal Bupivacaine |
|---|---|---|
| Hour 12 | 4.4 (0 to 10) | 5.64 (0 to 9) |
| Hour 48 | 5.7 (0 to 9) | 5.6 (2 to 8) |
| Hour 72 | 2.5 (0 to 5) | 7.0 (4 to 8) |
Morphine milligram equivalences consumed during hospital stay
| Morphine Milligram Equivalents | Bupivacaine Only | Liposomal Bupivacaine |
|---|---|---|
| Intraoperative Administration Bupivacaine: up to 24 hours Liposomal Bupivacaine: up to 25 hours | 11.67 (2 to 24) | 13.1 (10 to 25) |
| Post Anesthesia Care Unit (PACU) Bupivacaine: up to 9 hours Liposomal Bupivacaine: up to 6 hours | 4.67 (2 to 9) | 3.43 (2 to 6) |
| Floor Admin/Subject Room Bupivacaine: up to 6 hours Liposomal Bupivacaine: up to 22.5 hour | 3.8 (0.8 to 6) | 5.61 (1.6 to 22.5) |
Morphine milligram equivalences prescribed and consumed as measured at one week follow up clinic visit
No measurements were reported for this outcome.
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)
No measurements were reported for this outcome.
Hospital length of stay in hours
| hours | Bupivacaine Only | Liposomal Bupivacaine |
|---|---|---|
| Length of Hospital Stay | 24.5 (17.5 to 42) | 29.7 (20 to 68) |
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."
No measurements were reported for this outcome.
Collected over Week 1. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bupivacaine Only | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Liposomal Bupivacaine | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Age, Customized(Number of years) | Bupivacaine Only | Liposomal Bupivacaine | Total |
|---|---|---|---|
| Mean | 44 (22 to 66) | 43 (23 to 62) | 43.5 (22 to 66) |
| Sex: Female, Male(Participants) | Bupivacaine Only | Liposomal Bupivacaine | Total |
|---|---|---|---|
| Female | 31 | 32 | 63 |
| Male | 4 | 2 | 6 |
| Race (NIH/OMB)(Participants) | Bupivacaine Only | Liposomal Bupivacaine | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 15 | 14 | 29 |
| White | 19 | 18 | 37 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
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Wake Forest University Health Sciences