Clinical trial NCT02128646: Liposomal Bupivacaine (Exparel) for Postoperative Pain Control for Open and Laparoscopic Abdominal Hernia Repair
Official title: Liposomal Bupivacaine (Exparel) for Postoperative Pain Control for Open and Laparoscopic Abdominal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Pain Management
Exparel
Abdominal Hernia Repair
Laparoscopic Surgery
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2014-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient satisfaction with pain management after surgery
timeFrame: Change from Surgery to Day 14
Secondary outcomes:
measure: Total length of time in post-anesthesia care unit (PACU)
timeFrame: Up to 14 days
measure: Change in postsurgical opioid consumption
timeFrame: Change from Surgery to 72 hours post-surgery
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Michael Moncure, MD
role: PRINCIPAL_INVESTIGATOR
References: