Liposomal Bupivacaine (Exparel) for Postoperative Pain Control for Open and Laparoscopic Abdominal Hernia Repair

NCT02128646 | Completed Phase 4 Results

• 1 other identifier: STUDY00000101
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn how well Liposomal Bupivacaine (Exparel™) controls post-operative pain in patients undergoing both open and laparoscopic (minimally invasive) abdominal hernia repair surgery.

Conditions

Pain

Keywords

Pain Management; Exparel; Abdominal Hernia Repair; Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction With Pain Management After Surgery

  Satisfaction measured with composite score that includes score from the Likert scale and opioid consumption/satisfaction log. Satisfaction was rated on a scale of 1-5, with 1 being "strongly disagree"/not satisfied with pain control and 5 being "strongly agree"/satisfied with pain control. Patients filled out the log on days 1-4 after surgery and at a 7-14 day follow up visit.

  Change from Surgery to Day 14

Secondary Outcomes (1)

• Total Length of Time in Post-anesthesia Care Unit (PACU)

  Up to 385 minutes after surgery

Study Arms (4)

Treatment Group 1

EXPERIMENTAL

Treatment Group patients will receive an opioid-sparing, multimodal, postsurgical pain regimen consisting of intraoperative local wound infiltration with 266 mg EXPAREL followed by, when not contraindicated, administration of a 30 mg dose of IV ketorolac at the end of surgery. Patients scheduled in Treatment Group 1 will have an open surgery for abdominal hernia repair.

Drug: EXPAREL; Drug: Ketorolac; Procedure: an open surgery for abdominal hernia repair

Treatment Group 2

EXPERIMENTAL

Treatment Group patients will receive an opioid-sparing, multimodal, postsurgical pain regimen consisting of intraoperative local wound infiltration with 266 mg EXPAREL followed by, when not contraindicated, administration of a 30 mg dose of IV ketorolac at the end of surgery. Patients scheduled in Treatment Group 2 will have a laparoscopic abdominal hernia repair.

Drug: EXPAREL; Drug: Ketorolac; Procedure: laparoscopic abdominal hernia repair

Control Group 1

ACTIVE COMPARATOR

Patients scheduled in Control Group 1 will have an open surgery for abdominal hernia repair. The Control Group patients will receive traditional treatment.

Procedure: an open surgery for abdominal hernia repair

Control Group 2

ACTIVE COMPARATOR

Patients scheduled in Control Group 2 will have laparoscopic abdominal hernia repair. The Control Group patients will receive traditional treatment.

Procedure: laparoscopic abdominal hernia repair

Interventions

EXPAREL DRUG

Also known as: Bupivacaine Liposome Injectable Suspension

Treatment Group 1; Treatment Group 2

Ketorolac DRUG

Also known as: Toradol

Treatment Group 1; Treatment Group 2

laparoscopic abdominal hernia repair PROCEDURE

Control Group 2; Treatment Group 2

an open surgery for abdominal hernia repair PROCEDURE

Control Group 1; Treatment Group 1

Eligibility Criteria

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

You may qualify if:

• Patients scheduled to undergo an open or laparoscopic abdominal hernia repair.
• Ability to provide informed consent, adhere to study visit schedule, and complete all study assessments.

You may not qualify if:

• Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioids or ketorolac.
• Patients who abuse alcohol or other drug substance.
• Patients who are on chronic opioid therapy (taken an opioid 5 of the last 7 days).
• Patients with severe hepatic impairment.
• Patients currently pregnant.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Trial was ended prematurely due to administrative constraints and only reached half of the projected enrollment numbers.

Results Point of Contact

• Title: Michael Moncure, MD
• Organization: University of Kansas Medical Center

mmoncure@kumc.edu

913-588-1240

Study Officials

• Michael Moncure, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 1, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-09

Locations

US (1)