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OpenTrials
Completed

NCT Number: NCT02128646

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exparel

Drug

Other names: Bupivacaine Liposome Injectable Suspension

Ketorolac

Drug

Other names: Toradol

laparoscopic abdominal hernia repair

Procedure

an open surgery for abdominal hernia repair

Procedure

Primary outcomes

  1. Patient Satisfaction With Pain Management After Surgery

    Time frame: Change from Surgery to Day 14

    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.

Secondary outcomes

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

    Time frame: Up to 385 minutes after surgery

    Length of time subjects stayed in the PACU following surgery

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Pacira Pharmaceuticals, Inc

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 1, 2014
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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