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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02222129
• Other study ID #: 403263-1
• Secondary ID: BHS120036
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2014
• Last updated: April 6, 2015
• Start date: December 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Knight, Richard, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant and/or nursing mothers.

• Allergy to bupivacaine.

Study Design

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Bupivacaine

• liposomal bupivacaine

Locations

Country	Name	City	State
United States	Baptist Health System	San Antonio	Texas
United States	Methodist Healthcare System	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Knight, Richard, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	No
Secondary	Visual Analog Pain Scores.	Visual analog pain scores.	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.	No
Secondary	Length of Hospital Stay.	Length of hospital stay.	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.	No
Secondary	Time to First Opioid Use.	Time to first opioid use.	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.	No