Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures

March 29, 2024 updated by: D. Duane Baldwin, Loma Linda University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exparel
This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.
Drug: Exparel
This group will receive intraoperative local Liposomal Bupivacaine injection at the surgical site.
Other Names:
  • liposomal bupivacaine
Active Comparator: Marcaine
This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.
Drug: Marcaine
This group will receive intraoperative Bupivacaine HCl injection at the surgical site.
Other Names:
  • Bupivacaine HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 days 1-3
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 day 1
Length of Hospital Stay
Time Frame: Duration of stay in hours
Duration of hospital stay after the surgery until time of discharge
Duration of stay in hours
Postoperative Complications
Time Frame: 30 days postoperatively
Any complication related to the surgery within 30 days
30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Study Director: Mohamed Keheila, MD, Loma Linda University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2016

Primary Completion (Actual)

May 9, 2022

Study Completion (Actual)

May 9, 2022

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimated)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5160165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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