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

NCT02222129 | Completed Phase 4 Results

• 2 other identifiers: 403263-1BHS120036
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pain, Postoperative

Keywords

Randomized controlled trial; anesthetics-local; bupivacaine; analgesia; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

Surgical site infiltration of 0.25% bupivacaine.

Drug: Bupivacaine

Liposomal bupivacaine

EXPERIMENTAL

Surgical site infiltration of liposomal bupivacaine.

Drug: liposomal bupivacaine

Interventions

Bupivacaine DRUG

Bupivacaine

liposomal bupivacaine DRUG

Also known as: Exparel

Liposomal bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Knight, Richard, M.D.: lead

Study Sites (2)

Baptist Health System

San Antonio, Texas, 78205, United States

Location

Methodist Healthcare System

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Richard Knight, MD
• Organization: USAF

richard_b_knight@yahoo.com

+44 1638 528186

Study Officials

• Richard B Knight, MD

  San Antonio Uniformed Services Health Education Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 21, 2014
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 16, 2015
• Results First Posted: April 16, 2015

Record last verified: 2015-04

Locations

US (2)