NCT02805504

Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures

Completed Phase 4 Results posted Last updated 24 April 2024

What this trial tests

Phase 4 trial testing Exparel in Urinary Tract Diseases in 136 participants. Completed in 9 May 2022.

Timeline

11 July 2016

Primary endpoint
9 May 2022

9 May 2022

Quick facts

Lead sponsor	Loma Linda University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	136
Start date	11 July 2016
Primary completion	9 May 2022
Estimated completion	9 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Exparel — full drug profile →
• Marcaine

Conditions studied

• Urinary Tract Diseases — all drugs for Urinary Tract Diseases →

Sponsor

Loma Linda University

Who can join

18 and older, any sex, with Urinary Tract Diseases. 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 Primary · Postoperative days 1-3

Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively

Group	Value	95% CI
Exparel	16.4	± 19.4
Marcaine	15.3	± 16.2

Postoperative Pain Assessment Primary · Postoperative day 1

Pain score (0-10) will be used. This will be based on a standard visual analog scale, where 0 indicates no pain and 10 indicates the most severe pain reported by patients.

Group	Value	95% CI
Exparel	4.6	± 2.1
Marcaine	4.6	± 2.4

Length of Hospital Stay Primary · Duration of stay in hours

Duration of hospital stay after the surgery until time of discharge

Group	Value	95% CI
Exparel	37	± 31.8
Marcaine	36	± 24

Postoperative Complications Primary · 30 days postoperatively

Any complication related to the surgery within 30 days

Group	Value	95% CI
Exparel	6
Marcaine	6

Adverse events — posted to ClinicalTrials.gov

Time frame: 30-days postoperatively. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Exparel

Serious: 6/63 (10%)

Deaths: 0/63

Marcaine

Serious: 6/73 (8%)

Deaths: 0/73

Serious adverse events (4 terms)

Reaction	System	Exparel	Marcaine
Postoperative Ileus	Gastrointestinal disorders	—	—
Postoperative Bleeding	Surgical and medical procedures	—	—
Postoperative Hypotension	Surgical and medical procedures	—	—
Stricture	Renal and urinary disorders	—	—

Most-reported serious reactions: Postoperative Ileus, Postoperative Bleeding, Postoperative Hypotension, Stricture.

Data from ClinicalTrials.gov NCT02805504 adverse events section.

Sponsor's own description

A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.