Status:
COMPLETED
Extended Delivery of Bupivacaine Study in Herniorrhaphy
Lead Sponsor:
Heron Therapeutics
Conditions:
Analgesia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04102267
Start Date
July 2 2018
End Date
October 26 2018
Last Update
September 26 2019
Active Locations (1)
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1
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801