Efficacy of the Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures
Overview
- Phase
- Phase 4
- Intervention
- Exparel
- Conditions
- Urinary Tract Diseases
- Sponsor
- Loma Linda University
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Total Opioid Consumption
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
Investigators
D. Duane Baldwin
Professor
Loma Linda University
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.
Arms & Interventions
Exparel
This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.
Intervention: Exparel
Marcaine
This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.
Intervention: Marcaine
Outcomes
Primary Outcomes
Total Opioid Consumption
Time Frame: 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
Time Frame: 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
Time Frame: 30 days postoperatively
Any complication related to the surgery within 30 days
Length of Hospital Stay
Time Frame: Duration of stay in hours
Duration of hospital stay after the surgery until time of discharge