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Efficacy of Liposomal Bupivacaine Versus 0.25% Bupivacaine for Laparoscopic Urologic Surgery

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
liposomal bupivacaine
Sponsored by
Knight, Richard, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Randomized controlled trial, anesthetics-local, bupivacaine, analgesia, Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18-years-old, undergoing laparoscopic urologic surgery.

Exclusion Criteria:

  • Pregnant and/or nursing mothers.
  • Allergy to bupivacaine.

Sites / Locations

  • Baptist Health System
  • Methodist Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bupivacaine

Liposomal bupivacaine

Arm Description

Surgical site infiltration of 0.25% bupivacaine.

Surgical site infiltration of liposomal bupivacaine.

Outcomes

Primary Outcome Measures

Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay
Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay

Secondary Outcome Measures

Visual Analog Pain Scores.
Visual analog pain scores.
Length of Hospital Stay.
Length of hospital stay.
Time to First Opioid Use.
Time to first opioid use.

Full Information

First Posted
August 19, 2014
Last Updated
April 6, 2015
Sponsor
Knight, Richard, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT02222129
Brief Title
Efficacy of Liposomal Bupivacaine Versus 0.25% Bupivacaine for Laparoscopic Urologic Surgery
Official Title
A Randomized Controlled Trial for Pain Control in Laparoscopic Urologic Surgery: 0.25% Bupivacaine Versus Long-Acting Liposomal Bupivacaine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Knight, Richard, M.D.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A prospective, randomized comparison of bupivacaine to liposomal bupivacaine given by local injection at all the wound sites in patients undergoing robotic-assisted or laparoscopic urologic surgeries in an effort to determine which method reduced postoperative opioid use the most.
Detailed Description
Liposomal bupivacaine was developed to extend the duration of efficacy of bupivacaine from the typical 6 - 8 hours up to 72 hours. The prolonged duration of liposomal bupivacaine was initially demonstrated in mice in 1994. Two randomized controlled trials using liposomal bupivacaine for bunionectomy and hemorrhoidectomy resulted in FDA approval for its use in humans. More recently, liposomal bupivacaine has also been found to improve pain control for patients undergoing total knee arthroplasty. Infiltration of a local anesthetic into laparoscopic port sites is a common practice that has been shown in some studies to improve postoperative pain. To compare liposomal bupivacaine and 0.25% bupivacaine for local analgesia following laparoscopic and robotic urologic surgery, a randomized comparison-controlled trial was performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Randomized controlled trial, anesthetics-local, bupivacaine, analgesia, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
Surgical site infiltration of 0.25% bupivacaine.
Arm Title
Liposomal bupivacaine
Arm Type
Experimental
Arm Description
Surgical site infiltration of liposomal bupivacaine.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Type
Drug
Intervention Name(s)
liposomal bupivacaine
Other Intervention Name(s)
Exparel
Primary Outcome Measure Information:
Title
Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay
Description
Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay
Time Frame
All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
Secondary Outcome Measure Information:
Title
Visual Analog Pain Scores.
Description
Visual analog pain scores.
Time Frame
All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
Title
Length of Hospital Stay.
Description
Length of hospital stay.
Time Frame
All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.
Title
Time to First Opioid Use.
Description
Time to first opioid use.
Time Frame
All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18-years-old, undergoing laparoscopic urologic surgery. Exclusion Criteria: Pregnant and/or nursing mothers. Allergy to bupivacaine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B Knight, MD
Organizational Affiliation
San Antonio Uniformed Services Health Education Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Health System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Methodist Healthcare System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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Efficacy of Liposomal Bupivacaine Versus 0.25% Bupivacaine for Laparoscopic Urologic Surgery

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