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

Information source: Knight, Richard, M.D.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain, Postoperative

Intervention: Bupivacaine (Drug); liposomal bupivacaine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Knight, Richard, M.D.

Official(s) and/or principal investigator(s):
Richard B Knight, MD, Principal Investigator, Affiliation: San Antonio Uniformed Services Health Education Consortium


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.

Clinical Details

Official title: A Randomized Controlled Trial for Pain Control in Laparoscopic Urologic Surgery: 0.25% Bupivacaine Versus Long-Acting Liposomal Bupivacaine

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay

Secondary outcome:

Visual Analog Pain Scores.

Length of Hospital Stay.

Time to First Opioid Use.

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

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

Exclusion Criteria:

- Pregnant and/or nursing mothers.

- Allergy to bupivacaine.

Locations and Contacts

Baptist Health System, San Antonio, Texas 78205, United States

Methodist Healthcare System, San Antonio, Texas 78229, United States

Additional Information

Starting date: December 2012
Last updated: April 6, 2015

Page last updated: August 23, 2015

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