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

Knight, Richard, M.D.

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Bupivacaine; Drug: liposomal bupivacaine

Study type: Interventional

Identifiers

NCT02222129

BHS120036 (Other Identifier)

403263-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnant and/or nursing mothers.
• Allergy to bupivacaine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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206 participants in 2 patient groups

Bupivacaine

Active Comparator group

Description:

Surgical site infiltration of 0.25% bupivacaine.

Treatment:

Drug: Bupivacaine

Liposomal bupivacaine

Experimental group

Description:

Surgical site infiltration of liposomal bupivacaine.

Treatment:

Drug: liposomal bupivacaine