Clinical trial NCT04102267: Extended Delivery of Bupivacaine Study in Herniorrhaphy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Keywords: herniorrhaphy
inguinal hernia
hernia
hernia surgery
postoperative pain
Lead sponsor: Heron Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Mean area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) through 72 hours (AUC0-72)
timeFrame: 72 hours
Secondary outcomes:
measure: Total postoperative opioid consumption (in morphine equivalents)
timeFrame: 72 hours
measure: Proportion of subjects who are opioid-free
timeFrame: 72 hours
measure: Median time in hours to first opioid rescue medication
timeFrame: 72 hours
measure: Mean AUC0-72 of the NRS-R pain intensity scores.
timeFrame: 72 hours
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
Study officials:
References: