Extended Delivery of Bupivacaine Study in Herniorrhaphy

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal bupivacaine injection (Group 1)	Bupivacaine liposome injectable suspension	Liposomal bupivacaine 266 mg via injection
Bupivacaine HCl continuous infusion (Group 2)	Bupivacaine HCl without epinephrine via continuous infusion	Bupivacaine HCl 300 mg via continuous infusion

Primary Outcome Measures

Name	Time	Method
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

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

Extended Delivery of Bupivacaine Study in Herniorrhaphy

Recruitment & Eligibility

Study & Design

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