Title

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

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    206
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.
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.
Study Started
Dec 31
2012
Primary Completion
Dec 31
2013
Study Completion
Dec 31
2013
Results Posted
Apr 16
2015
Estimate
Last Update
Apr 16
2015
Estimate

Drug Bupivacaine

Drug liposomal bupivacaine

  • Other names: Exparel

Bupivacaine Active Comparator

Surgical site infiltration of 0.25% bupivacaine.

Liposomal bupivacaine Experimental

Surgical site infiltration of liposomal bupivacaine.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant and/or nursing mothers.
Allergy to bupivacaine.

Summary

Bupivacaine

Liposomal Bupivacaine

All Events

Event Type Organ System Event Term

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

Bupivacaine

17.3
mg (morphine equivalents) (Median)
Inter-Quartile Range: 8.3 to 30.5

Liposomal Bupivacaine

15.0
mg (morphine equivalents) (Median)
Inter-Quartile Range: 6.7 to 27.0

Visual Analog Pain Scores.

Visual analog pain scores.

Outcome Measure Data Not Reported

Length of Hospital Stay.

Length of hospital stay.

Outcome Measure Data Not Reported

Time to First Opioid Use.

Time to first opioid use.

Outcome Measure Data Not Reported

Total

191
Participants

BMI

28.7
kg/m2 (Median)
Inter-Quartile Range: 25.6 to 33.3

Age, Customized

Race/Ethnicity, Customized

Region of Enrollment

Sex: Female, Male

Overall Study

Bupivacaine

Liposomal Bupivacaine