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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: EXPAREL; Drug: Ketorolac; Procedure: laparoscopic abdominal hernia repair; Procedure: an open surgery for abdominal hernia repair

• Registration Number: NCT02128646
• Lead Sponsor: Michael Moncure, MD

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-01
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	EXPAREL	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.
Treatment Group 1	Ketorolac	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.
Treatment Group 2	laparoscopic abdominal hernia repair	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.
Treatment Group 1	an open surgery for abdominal hernia repair	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.
Treatment Group 2	EXPAREL	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.
Treatment Group 2	Ketorolac	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.
Control Group 1	an open surgery for abdominal hernia repair	Patients scheduled in Control Group 1 will have an open surgery for abdominal hernia repair. The Control Group patients will receive traditional treatment.
Control Group 2	laparoscopic abdominal hernia repair	Patients scheduled in Control Group 2 will have laparoscopic abdominal hernia repair. The Control Group patients will receive traditional treatment.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction with pain management after surgery	Change from Surgery to Day 14	Satisfaction measured with composite score that includes score from the Likert scale and opiod consumption/satisfaction log.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States