Analgesia
Conditions
Keywords
herniorrhaphy, inguinal hernia, hernia, hernia surgery, postoperative pain
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.
Interventions
Liposomal bupivacaine 266 mg via injection
DRUGBupivacaine HCl without epinephrine via continuous infusion
Bupivacaine HCl 300 mg via continuous infusion
Sponsors
Heron Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Total postoperative opioid consumption (in morphine equivalents) | 72 hours |
| Proportion of subjects who are opioid-free | 72 hours |
| Median time in hours to first opioid rescue medication | 72 hours |
| Mean AUC0-72 of the NRS-R pain intensity scores. | 72 hours |
Countries
United States
Outcome results
None listed