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

Michael Moncure, MD

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Ketorolac; Drug: EXPAREL; Procedure: an open surgery for abdominal hernia repair; Procedure: laparoscopic abdominal hernia repair

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02128646

STUDY00000101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Treatment Group 1

Experimental group

Description:

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:

Procedure: an open surgery for abdominal hernia repair

Drug: EXPAREL

Drug: Ketorolac

Treatment Group 2

Experimental group

Description:

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:

Drug: EXPAREL

Drug: Ketorolac

Procedure: laparoscopic abdominal hernia repair

Control Group 1

Active Comparator group

Description:

Patients scheduled in Control Group 1 will have an open surgery for abdominal hernia repair. The Control Group patients will receive traditional treatment.

Treatment:

Procedure: an open surgery for abdominal hernia repair

Control Group 2

Active Comparator group

Description:

Patients scheduled in Control Group 2 will have laparoscopic abdominal hernia repair. The Control Group patients will receive traditional treatment.

Treatment:

Procedure: laparoscopic abdominal hernia repair