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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Michael Moncure, MD

Current Primary Outcome: 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 opiod consumption/satisfaction log.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Total length of time in post-anesthesia care unit (PACU) [ Time Frame: Up to 14 days ]
    Length of time subject stays in the PACU
  • Change in postsurgical opioid consumption [ Time Frame: Change from Surgery to 72 hours post-surgery ]
    Measure using date, time, amount, and route of opioids administered during the time frame


Original Secondary Outcome: Same as current

Information By: University of Kansas Medical Center

Dates:
Date Received: April 29, 2014
Date Started: April 2014
Date Completion:
Last Updated: January 17, 2017
Last Verified: January 2017