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Clinical trial

Efficacy of the Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures

ID
Name
5160165
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.
Trial arms
Trial start
2016-07-11
Estimated PCD
2022-05-09
Trial end
2022-05-09
Status
Completed
Phase
Early phase I
Treatment
Exparel
This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.
Arms:
Exparel
Other names:
liposomal bupivacaine
Marcaine
This group will receive intraoperative Bupivacaine HCl injection at the surgical site.
Arms:
Marcaine
Other names:
Bupivacaine HCl
Size
136
Primary endpoint
Total Opioid Consumption
Postoperative days 1-3
Postoperative Pain Assessment
Postoperative day 1
Length of Hospital Stay
Duration of stay in hours
Postoperative Complications
30 days postoperatively
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 136, 'type': 'ACTUAL'}}
Updated at
2024-04-24

1 organization

2 products

1 indication

Organization
Loma Linda University
Product
Exparel
Indication
Urinary Tract Infections
Product
Marcaine