Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-11

Study Completion Date

2022-05-09

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.

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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

Conditions

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Urinary Tract Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Exparel

This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.

Group Type EXPERIMENTAL

Exparel

Intervention Type DRUG

This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.

Marcaine

This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.

Group Type ACTIVE_COMPARATOR

Marcaine

Intervention Type DRUG

This group will receive intraoperative Bupivacaine HCl injection at the surgical site.

Interventions

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Exparel

This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.

Intervention Type DRUG

Marcaine

This group will receive intraoperative Bupivacaine HCl injection at the surgical site.

Intervention Type DRUG

Other Intervention Names

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liposomal bupivacaine Bupivacaine HCl

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No