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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128646
• Other study ID #: STUDY00000101
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2014
• Last updated: January 17, 2017
• Start date: April 2014
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Abdominal
• Pain
• Pain, Postoperative

Intervention

Drug:
• EXPAREL

• Ketorolac

Procedure:
• laparoscopic abdominal hernia repair

• an open surgery for abdominal hernia repair

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Michael Moncure, MD	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction with pain management after surgery	Satisfaction measured with composite score that includes score from the Likert scale and opiod consumption/satisfaction log.	Change from Surgery to Day 14
Secondary	Total length of time in post-anesthesia care unit (PACU)	Length of time subject stays in the PACU	Up to 14 days
Secondary	Change in postsurgical opioid consumption	Measure using date, time, amount, and route of opioids administered during the time frame	Change from Surgery to 72 hours post-surgery