NCT03250507

Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy

Completed Phase 4 Results posted Last updated 21 December 2022

What this trial tests

Phase 4 trial testing Bupivacaine in Hysterectomy in 90 participants. Completed in 30 January 2019.

Timeline

13 March 2017

Primary endpoint
30 January 2019

30 January 2019

Quick facts

Lead sponsor	Henry Ford Health System
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	90
Start date	13 March 2017
Primary completion	30 January 2019
Estimated completion	30 January 2019
Sites	1 location across United States

Drugs / interventions tested

• Bupivacaine (BUPIVACAINE) — full drug profile →
• Liposomal bupivacaine — full drug profile →
• Saline

Conditions studied

• Hysterectomy — all drugs for Hysterectomy →

Sponsor

Henry Ford Health System — full company profile →

Who can join

18 and older, female only, with Hysterectomy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg) Primary · 0 - 72 hours post-operatively

Total opioid consumption

Group	Value	95% CI
Bupivacaine	208	155 – 270
Liposomal Bupivacaine	203	153 – 283
Liposomal Bupivacaine and Bupivacaine	202	116 – 325

Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given Primary · 0 - 72 hours post-operatively

time to first opioid given

Group	Value	95% CI
Bupivacaine	51	28 – 66
Liposomal Bupivacaine	63	44 – 102
Liposomal Bupivacaine and Bupivacaine	51	24 – 84

Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied Secondary · 0 - 72 hours post-operatively

Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.

Group	Value	95% CI
Bupivacaine	9
Liposomal Bupivacaine	13
Liposomal Bupivacaine and Bupivacaine	9

Length of Stay in the Hospital Secondary · until the patient is discharged from the hospital

Length of stay in the hospital, maximum time until discharge from the hospital

Group	Value	95% CI
Bupivacaine	79	61 – 122
Liposomal Bupivacaine	82	72 – 102
Liposomal Bupivacaine and Bupivacaine	80	76 – 107

Number of Patients With Local Anesthetic Toxicity Secondary · 0 - 72 hours post-operatively

Presence of local anesthetic toxicity

Group	Value	95% CI
Bupivacaine	0
Liposomal Bupivacaine	0
Liposomal Bupivacaine and Bupivacaine	0

Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure Secondary · 0 - 72 hours post-operatively

Presence of hemodynamic instability

Group	Value	95% CI
Bupivacaine	0
Liposomal Bupivacaine	1
Liposomal Bupivacaine and Bupivacaine	5

Pain Scores Using Visual Analogue Scale ( 0-10) Secondary · 0-24 postoperative pain scores

Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.

Group	Value	95% CI
Bupivacaine	8	7 – 9
Liposomal Bupivacaine	7	6 – 7
Liposomal Bupivacaine and Bupivacaine	7	5 – 8

Sponsor's own description

The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A randomized-controlled trial comparing liposomal bupivacaine, plain bupivacaine, and the mixture of liposomal bupivacaine and plain bupivacaine in transversus abdominus plane block for postoperative analgesia for open abdominal hysterectomies.
   Fidkowski CW, Choksi N, Alsaden MR. · · 2021 · cited 15× · PMID 33432496 · DOI 10.1007/s12630-020-01911-1