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

NCT ID: NCT02128646

Last Updated: 2025-09-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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When a person has surgery, there are a few different standard care options for pain relief. Anesthetic (numbing) drugs can be used to cause a loss of feeling in or around a wound but the effect of the numbing medication can be undone.Pain relieving drugs such as acetaminophen (Tylenol), non-steroidal anti-inflammatory drugs (NSAIDs), and opioid (narcotic) medications can also be taken by mouth or through a vein in your arm (intravenous IV.) However, both NSAIDs \& Opioid drugs can produce negative side effects such as serious difficulty breathing, stopping breathing altogether, low blood pressure, nausea, vomiting, itching, and constipation.

Bupivacaine is one of the commonly used longer-acting numbing medicines (anesthetics). The effect of Bupivacaine or other anesthetics is limited to usually no more than 12 hours when injected around the area of the incision during surgery. Liposomal Bupivacaine (Exparel) could provide good, continuous and longer pain relief than current therapies/treatments commonly used. This can possibly improve patient satisfaction and time to normal activities such as walking.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group 1

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.

Group Type EXPERIMENTAL

EXPAREL

Intervention Type DRUG

Ketorolac

Intervention Type DRUG

an open surgery for abdominal hernia repair

Intervention Type PROCEDURE

Treatment Group 2

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.

Group Type EXPERIMENTAL

EXPAREL

Intervention Type DRUG

Ketorolac

Intervention Type DRUG

laparoscopic abdominal hernia repair

Intervention Type PROCEDURE

Control Group 1

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

Group Type ACTIVE_COMPARATOR

an open surgery for abdominal hernia repair

Intervention Type PROCEDURE

Control Group 2

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

Group Type ACTIVE_COMPARATOR

laparoscopic abdominal hernia repair

Intervention Type PROCEDURE

Interventions

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EXPAREL

Intervention Type DRUG

Ketorolac

Intervention Type DRUG

laparoscopic abdominal hernia repair

Intervention Type PROCEDURE

an open surgery for abdominal hernia repair

Intervention Type PROCEDURE

Other Intervention Names

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Bupivacaine Liposome Injectable Suspension Toradol

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Moncure, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00000101

Identifier Type: -

Identifier Source: org_study_id

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