Trial Outcomes & Findings for Transversus Abdominis Plane (TAP) Block Using Liposomal Bupivacaine in Metabolic and Bariatric Surgery Patients (NCT NCT05537883)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

72 participants

Primary outcome timeframe

Hour 24

Results posted on

2025-06-11

Participant Flow

3 of the subjects were not randomized or assigned

Participant milestones

Participant milestones
Measure	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. Bupivacaine Injection: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine	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. Liposomal bupivacaine: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine
Overall Study STARTED	35	34
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	35	34

Reasons for withdrawal

Reasons for withdrawal
Measure	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. Bupivacaine Injection: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine	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. Liposomal bupivacaine: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine
Overall Study revisional surgery	4	2
Overall Study surgeries were cancelled	0	2
Overall Study not being compliant with the Seamless MD app	31	30

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupivacaine Only n=35 Participants 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. Bupivacaine Injection: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine	Liposomal Bupivacaine n=34 Participants 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. Liposomal bupivacaine: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine	Total n=69 Participants Total of all reporting groups
Age, Customized	44 Number of years n=5 Participants	43 Number of years n=7 Participants	43.5 Number of years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	32 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Hour 24

Population: The numbers analyzed meaning those who received the bupivacaine or not were 35 and 34 However, the Post-Anesthesia Care Unit team nurses did not obtain pain scores on everyone so what is listed is the data of what we had, which is less. This is why it doesn't add up.

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.

Outcome measures

Outcome measures
Measure	Bupivacaine Only n=29 Participants 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. Bupivacaine Injection: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine	Liposomal Bupivacaine n=27 Participants 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. Liposomal bupivacaine: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine
Mean 24 Hour Visual Analogue Scale (VAS) Pain Score	1 score on a scale Interval 0.0 to 5.0	3 score on a scale Interval 0.0 to 9.0

SECONDARY outcome

Timeframe: Hours,12, 48, and 72

Population: Difference in Number of Subjects at different Hours due to subjects being non-compliant: not entering information into Seamless MD app; data not being collected The numbers analyzed meaning those who received the bupivacaine or not were 35 and 34 However, the Post-Anesthesia Care Unit team nurses did not obtain pain scores on 6 Subjects in Bupivacaine Group and 7 Subjects in the Liposomal Bupivacaine Group

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

Outcome measures

Outcome measures
Measure	Bupivacaine Only n=29 Participants 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. Bupivacaine Injection: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine	Liposomal Bupivacaine n=27 Participants 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. Liposomal bupivacaine: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine
Mean Visual Analogue Scale (VAS) Pain Scores Hour 12	4.4 score on a scale Interval 0.0 to 10.0	5.64 score on a scale Interval 0.0 to 9.0
Mean Visual Analogue Scale (VAS) Pain Scores Hour 48	5.7 score on a scale Interval 0.0 to 9.0	5.6 score on a scale Interval 2.0 to 8.0
Mean Visual Analogue Scale (VAS) Pain Scores Hour 72	2.5 score on a scale Interval 0.0 to 5.0	7.0 score on a scale Interval 4.0 to 8.0

SECONDARY outcome

Timeframe: Day 3

Morphine milligram equivalences consumed during hospital stay

Outcome measures

Outcome measures
Measure	Bupivacaine Only n=35 Participants 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. Bupivacaine Injection: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine	Liposomal Bupivacaine n=34 Participants 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. Liposomal bupivacaine: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine
Mean Average Morphine Equivalences Intraoperative Administration Bupivacaine: up to 24 hours Liposomal Bupivacaine: up to 25 hours	11.67 Morphine Milligram Equivalents Interval 2.0 to 24.0	13.1 Morphine Milligram Equivalents Interval 10.0 to 25.0
Mean Average Morphine Equivalences Post Anesthesia Care Unit (PACU) Bupivacaine: up to 9 hours Liposomal Bupivacaine: up to 6 hours	4.67 Morphine Milligram Equivalents Interval 2.0 to 9.0	3.43 Morphine Milligram Equivalents Interval 2.0 to 6.0
Mean Average Morphine Equivalences Floor Admin/Subject Room Bupivacaine: up to 6 hours Liposomal Bupivacaine: up to 22.5 hour	3.8 Morphine Milligram Equivalents Interval 0.8 to 6.0	5.61 Morphine Milligram Equivalents Interval 1.6 to 22.5

SECONDARY outcome

Timeframe: Week 1

Population: There were no data points as no patient completed or were non-compliant in completing their Seamless MD Mean Morphine Milligram Equivalents (MME) use and lack of compliance of clinic obtaining this data and submitting into redcap.

Morphine milligram equivalences prescribed and consumed as measured at one week follow up clinic visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 1

Population: There were no data points as no patient completed or were non-compliant in completing their Seamless MD MME use and lack of compliance of clinic obtaining this data and submitting into redcap.

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 3

Hospital length of stay in hours

Outcome measures

Outcome measures
Measure	Bupivacaine Only n=35 Participants 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. Bupivacaine Injection: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with plain bupivacaine	Liposomal Bupivacaine n=34 Participants 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. Liposomal bupivacaine: Patients receiving the intervention will undergo Transversus Abdominis Plane (TAP) block with liposomal bupivacaine
Length of Hospital Stay	24.5 hours Interval 17.5 to 42.0	29.7 hours Interval 20.0 to 68.0

SECONDARY outcome

Timeframe: Day 30

Population: There were no data points as no patient completed or were non-compliant in completing their Seamless MD MME use and lack of compliance of clinic obtaining this data and submitting into redcap.

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."

Outcome measures

Outcome data not reported

Adverse Events

Bupivacaine Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Selwan Barbat, MD

Wake Forest University Health Sciences

Phone: 704-355-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place