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