Trial Outcomes & Findings for TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy (NCT NCT02289079)

Results Overview

To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

0-72 hours after injection

Results posted on

2023-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	Liposomal Bupivacaine TAP these patients receive a subcostal TAP with liposomal bupivacaine liposomal bupivacaine	Bupivacaine TAP These patients receive a subcostal TAP with bupivacaine Bupivacaine
Overall Study STARTED	30	30
Overall Study COMPLETED	28	29
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Liposomal Bupivacaine TAP these patients receive a subcostal TAP with liposomal bupivacaine liposomal bupivacaine	Bupivacaine TAP These patients receive a subcostal TAP with bupivacaine Bupivacaine
Overall Study Physician Decision	2	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liposomal Bupivacaine TAP n=28 Participants these patients receive a subcostal TAP with liposomal bupivacaine liposomal bupivacaine	Bupivacaine TAP n=30 Participants These patients receive a subcostal TAP with bupivacaine Bupivacaine	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	25 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	30 participants n=7 Participants	58 participants n=5 Participants
weight	89.3 kilograms STANDARD_DEVIATION 25.1 • n=5 Participants	98.5 kilograms STANDARD_DEVIATION 34.2 • n=7 Participants	93.5 kilograms STANDARD_DEVIATION 30.2 • n=5 Participants

PRIMARY outcome

Timeframe: 0-72 hours after injection

To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine TAP n=28 Participants these patients receive a subcostal TAP with liposomal bupivacaine liposomal bupivacaine	Bupivacaine TAP n=29 Participants These patients receive a subcostal TAP with bupivacaine Bupivacaine
Post Operative Opioid Use	24.9 micrograms of fentanyl equivalents Interval 0.0 to 86.7	51.7 micrograms of fentanyl equivalents Interval 0.0 to 249.7

SECONDARY outcome

Timeframe: 48-72 hours

This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine TAP n=28 Participants these patients receive a subcostal TAP with liposomal bupivacaine liposomal bupivacaine	Bupivacaine TAP n=29 Participants These patients receive a subcostal TAP with bupivacaine Bupivacaine
Numerical Rating Scale	3 scores on a scale Interval 0.0 to 8.0	5 scores on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: up to 30 days after surgery

To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine TAP n=28 Participants these patients receive a subcostal TAP with liposomal bupivacaine liposomal bupivacaine	Bupivacaine TAP n=29 Participants These patients receive a subcostal TAP with bupivacaine Bupivacaine
Post Operative Length of Stay	11 Hours Standard Deviation 9.1	17 Hours Standard Deviation 13.9

SECONDARY outcome

Timeframe: assessed at 72 hours after injection

To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.

Outcome measures

Outcome measures
Measure	Liposomal Bupivacaine TAP n=28 Participants these patients receive a subcostal TAP with liposomal bupivacaine liposomal bupivacaine	Bupivacaine TAP n=29 Participants These patients receive a subcostal TAP with bupivacaine Bupivacaine
Patient Satisfaction as Assessed Via Patient Survey	26 participants satisfied with pain control	24 participants satisfied with pain control

Adverse Events

Liposomal Bupivacaine TAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine TAP

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

Dr. Jacob Hutchins

University of MInnesota

Phone: 6126249990

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place