Extended Delivery of Bupivacaine Study in Herniorrhaphy

NCT ID: NCT04102267

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-02
• Study Completion Date: 2018-10-26

Brief Summary

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.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Liposomal bupivacaine injection (Group 1)

Liposomal bupivacaine 266 mg via injection

Group Type: EXPERIMENTAL

Bupivacaine liposome injectable suspension

Intervention Type: DRUG

Liposomal bupivacaine 266 mg via injection

Bupivacaine HCl continuous infusion (Group 2)

Bupivacaine HCl 300 mg via continuous infusion

Group Type: EXPERIMENTAL

Bupivacaine HCl without epinephrine via continuous infusion

Intervention Type: DRUG

Bupivacaine HCl 300 mg via continuous infusion

Interventions

Bupivacaine liposome injectable suspension

Liposomal bupivacaine 266 mg via injection

Intervention Type: DRUG

Bupivacaine HCl without epinephrine via continuous infusion

Bupivacaine HCl 300 mg via continuous infusion

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heron Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Countries

United States

Other Identifiers

BUPI-501

Identifier Type: -

Identifier Source: org_study_id