Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures

Phase 4

Completed

• Conditions: Urinary Tract Diseases
• Interventions: Drug: Exparel; Drug: Marcaine

• Registration Number: NCT02805504
• Lead Sponsor: Loma Linda University

Brief Summary

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.

Detailed 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. Subjects of prospective study will be randomly divided using electronic program into two groups:

The first group will receive intraoperative local Liposomal Bupivacaine injection at the port placement site. The control group will receive will local Marcaine (bupivacaine HCl) injection

Primary Outcome Measures:

* Total opioid consumption measured in intravenous morphine equivalents dose during the postoperative hospital Stay

* Postoperative pain assessment using visual Analog Pain Scores \& Brief Pain Inventory form.

* Length of Hospital Stay

* Time to First Opioid Use.

* Postoperative Constipation , paralytic ileus

Study Timeline

• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-15
• Study First Posted: 2016-06-20
• Study Start: 2016-07-11
• Primary Completion: 2022-05-09
• Study Completion: 2022-05-09
• Results First Submitted: 2023-05-08
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-29
• Last Update Submitted: 2024-03-29
• Results First Posted: 2024-04-24
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Patients undergoing urologic surgery.

Exclusion Criteria

• Pregnant and/or nursing mothers.
• Allergy to bupivacaine.
• History of drug/alcohol abuse.
• Severe cardiovascular, hepatic, renal disease or neurological impairment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exparel	Exparel	This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.
Marcaine	Marcaine	This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.

Primary Outcome Measures

Name	Time	Method
Total Opioid Consumption	Postoperative days 1-3	Postoperative analgesic use will be measured in oral morphine equivalents dose given to patients in the first three days postoperatively
Postoperative Pain Assessment	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.
Postoperative Complications	30 days postoperatively	Any complication related to the surgery within 30 days
Length of Hospital Stay	Duration of stay in hours	Duration of hospital stay after the surgery until time of discharge

Trial Locations

Locations (1)

Loma Linda Medical Center; 🇺🇸 Loma Linda, California, United States