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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: EXPAREL
* Drug: Ketorolac
* Procedure: laparoscopic abdominal hernia repair
* Procedure: an open surgery for abdominal hernia repair


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 1<br>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. | Drug: EXPAREL<br> <br> * Other names: Bupivacaine Liposome Injectable Suspension;Drug: Ketorolac<br> <br> * Other names: Toradol;Procedure: an open surgery for abdominal hernia repair<br> <br> |
| Experimental: Treatment Group 2<br>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. | Drug: EXPAREL<br> <br> * Other names: Bupivacaine Liposome Injectable Suspension;Drug: Ketorolac<br> <br> * Other names: Toradol;Procedure: laparoscopic abdominal hernia repair<br> <br> |
| Active Comparator: Control Group 1<br>Patients scheduled in Control Group 1 will have an open surgery for abdominal hernia repair. The Control Group patients will receive traditional treatment. | Procedure: an open surgery for abdominal hernia repair<br> <br> |
| Active Comparator: Control Group 2<br>Patients scheduled in Control Group 2 will have laparoscopic abdominal hernia repair. The Control Group patients will receive traditional treatment. | Procedure: laparoscopic abdominal hernia repair<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total length of time in post-anesthesia care unit (PACU) | Length of time subject stays in the PACU | Up to 14 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain Management, Exparel, Abdominal Hernia Repair, Laparoscopic Surgery