Liposomal Bupivacaine for Postoperative Pain Control in Urologic Procedures

Loma Linda University (LLU)

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Diseases

Treatments: Drug: Exparel; Drug: Marcaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02805504

5160165

Details and patient eligibility

About

A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries.

Full description

A prospective, randomized controlled study to determine the efficacy of liposomal bupivacaine given by local injection at all the wound sites in patients undergoing urologic surgeries. Subjects of prospective study will be randomly divided using electronic program into two groups:

The first group will receive intraoperative local Liposomal Bupivacaine injection at the port placement site. The control group will receive will local Marcaine (bupivacaine HCl) injection

Primary Outcome Measures:

• Total opioid consumption measured in intravenous morphine equivalents dose during the postoperative hospital Stay
• Postoperative pain assessment using visual Analog Pain Scores & Brief Pain Inventory form.
• Length of Hospital Stay
• Time to First Opioid Use.
• Postoperative Constipation , paralytic ileus

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing urologic surgery.

Exclusion criteria

• Pregnant and/or nursing mothers.
• Allergy to bupivacaine.
• History of drug/alcohol abuse.
• Severe cardiovascular, hepatic, renal disease or neurological impairment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Exparel

Experimental group

Description:

This arm will receive intraoperative local Liposomal Bupivacaine injection (Exparel) at the port placement site.

Treatment:

Drug: Exparel

Marcaine

Active Comparator group

Description:

This group will receive will local bupivacaine HCl (Marcaine) injection at the port placement site.

Treatment:

Drug: Marcaine