Extended Delivery of Bupivacaine Study in Herniorrhaphy

Heron Therapeutics

Status and phase

Completed

Phase 4

Conditions

Analgesia

Treatments

Drug: Bupivacaine liposome injectable suspension

Drug: Bupivacaine HCl without epinephrine via continuous infusion

Study type

Interventional

Funder types

Industry

Identifiers

NCT04102267

BUPI-501

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.