Exparel vs. Bupivacaine Hydrochloride vs. Placebo for Hernia Repair

• Status: Completed
• Trial end date: 2019-12-19
• Target enrollment: 0
• Participant gender: All

Summary

Patients usually experience some level of pain after their hernia repair. To control pain after the operation, surgeons have many options. One of them is to make some injections of pain blocker medications into the nerves that are responsible for the sensations the abdominal wall.This procedure is called TAP block (transversus abdominis place block). These medications are called local anesthetics, and there is a variety of medications that can be used. One of such medications is called Exparel® (Liposomal Bupivacaine). Exparel® has the potential benefit of lasting more hours than regular anesthetics. Although this drug is being used with increasing frequency, the investigators do not have good quality studies investigating the benefits of using this medication during a hernia repair, especially when compared to other types of local anesthetics (Bupivacaine Hydrochloride) or when compared to not injecting this medication at all. This study aim to investigate if Exparel®, when injected in the nerves of the abdominal wall during hernia repair can: (1) reduce the dose of additional opioid medications (morphine and similar) needed to achieve good pain control and (2) result in lower pain scores. The hypothesis is that Exparel® will result in a 30% decrease in the total requirements for opioid medications during the first 72 hours after surgery. Patients will be randomized to receive either Exparel®+Bupivacaine Hydrochloride, Bupivacaine Hydrochloride or Placebo (normal saline) during the operation through a TAP block. All patients will receive a patient controlled analgesia device after the operation, where patients can simply push a button every time they feel pain and the device will administer a dose of opioid medications. The investigators of the study will record the necessary amount of opioids used by the patients to achieve good pain control and also record pain scores several times during hospital stay.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Patients with Primary Ventral or Incisional Hernias

• Scheduled to undergo hernia repair through an open approach

• Hernia repair performed in an elective setting

• Hernia repair performed through a midline incision

• Hernia repair performed in a clean wound

• Hernia repair performed with mesh placed in the retromuscular position

Exclusion Criteria:

• patients with less than 18 years old of age

• patients scheduled to undergo a minimally invasive hernia repair

• patients where hernia repair is planned to be performed with mesh placement in a different position than retromuscular

• patient undergoing hernia repair with a clean-contaminated, contaminated or infected wound

• patients undergoing hernia repair in an non-elective fashion

• patients with allergy, hypersensitivity or contraindication to bupivacaine

• patients with history of chronic liver disease with moderate or severe impairment in liver function defined as a Child-Pugh class B or C

• patients with chronic kidney disease on dialysis

• chronic opioid users, defined as daily or near daily use of opioids for at least 90 days in the past year

• patients unable to provide informed written consent