Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Urinary Tract Diseases

Intervention / Treatment
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* Drug: Exparel
* Drug: Marcaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exparel<br>This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site. | Drug: Exparel<br>* This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.<br>* Other names: liposomal bupivacaine;|
| Active Comparator: Marcaine<br>This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site. | Drug: Marcaine<br>* This group will receive intraoperative Bupivacaine HCl injection at the surgical site.<br>* Other names: Bupivacaine HCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total opioid consumption | Postoperative analgesic use will be measured in oral morphine equivalents dose | Postoperative day1-3 | 
| Postoperative pain assessment | Pain score (1-10) will be used. | Postoperative day1-3 | 
| Length of Hospital Stay and readmission |  | 30 days postoperatively | 
| Postoperative complications |  | 30 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bupivacaine, Minimally Invasive Surgical Procedures