Extended Delivery of Bupivacaine Study in Herniorrhaphy

Study Overview
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Brief Summary
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This is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal herniorrhaphy.

Official Title
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A Randomized, Phase 4 Study of the Efficacy, Safety, and Pharmacokinetics of Bupivacaine Administered as Liposomal Bupivacaine or Continuous Infusion Via Elastomeric Pump Following Unilateral Open Inguinal Herniorrhaphy

Conditions
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Analgesia

Intervention / Treatment
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* Drug: Bupivacaine liposome injectable suspension
* Drug: Bupivacaine HCl without epinephrine via continuous infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia Has an American Society of Anesthesiologists Physical Status of I, II, or III Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile,or using acceptable contraceptives. Exclusion Criteria: Had any prior inguinal hernia repair Has a planned concurrent surgical procedure Has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. Has taken any NSAIDs within least 10 days prior to the scheduled surgery Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting) Has been administered bupivacaine within 5 days prior to the scheduled surgery. Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control. Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study. Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives Has undergone 3 or more surgeries within 12 months Has a body mass index (BMI) >39 kg/m2.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal bupivacaine injection (Group 1)<br>Liposomal bupivacaine 266 mg via injection | Drug: Bupivacaine liposome injectable suspension<br>* Liposomal bupivacaine 266 mg via injection<br>|
| Experimental: Bupivacaine HCl continuous infusion (Group 2)<br>Bupivacaine HCl 300 mg via continuous infusion | Drug: Bupivacaine HCl without epinephrine via continuous infusion<br>* Bupivacaine HCl 300 mg via continuous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) through 72 hours (AUC0-72) |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total postoperative opioid consumption (in morphine equivalents) |  | 72 hours | 
| Proportion of subjects who are opioid-free |  | 72 hours | 
| Median time in hours to first opioid rescue medication |  | 72 hours | 
| Mean AUC0-72 of the NRS-R pain intensity scores. |  | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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herniorrhaphy, inguinal hernia, hernia, hernia surgery, postoperative pain