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

NCT ID: NCT02222129

Last Updated: 2015-04-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative

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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Bupivacaine

Surgical site infiltration of 0.25% bupivacaine.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Liposomal bupivacaine

Surgical site infiltration of liposomal bupivacaine.

Group Type EXPERIMENTAL

liposomal bupivacaine

Intervention Type DRUG

Interventions

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Bupivacaine

Intervention Type DRUG

liposomal bupivacaine

Intervention Type DRUG

Other Intervention Names

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Exparel

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant and/or nursing mothers.
* Allergy to bupivacaine.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Knight, Richard, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard B Knight, MD

Role: PRINCIPAL_INVESTIGATOR

San Antonio Uniformed Services Health Education Consortium

Locations

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Baptist Health System

San Antonio, Texas, United States

Site Status

Methodist Healthcare System

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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BHS120036

Identifier Type: OTHER

Identifier Source: secondary_id

403263-1

Identifier Type: -

Identifier Source: org_study_id

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