Analgesia
Conditions
Keywords
inguinal hernia, postoperative pain, herniorrhaphy, pediatric, local anesthetic
Brief summary
This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.
Interventions
DRUGHTX-011
Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.
DRUGBupivacaine HCl
Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).
DEVICELuer Lock Applicator
Applicator for instillation.
Sponsors
Heron Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Is scheduled to undergo a unilateral open inguinal herniorrhaphy with or without 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
* 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 planned concurrent surgical procedure (eg, bilateral herniorrhaphy). * Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. * Has taken meloxicam within least 10 days prior to the scheduled surgery. * Has been administered bupivacaine within 5 days prior to the scheduled surgery. * Has been administered any local anesthetic within 72 hours prior to the scheduled surgery. * 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 at the discretion of the Sponsor. Subjects taking any marijuana (medical or recreational) are not allowed to participate in the study. * Previously participated in an HTX-011 study. * Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives. * Has a body mass index (BMI) \>35 kg/m2. In addition to the preceding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf) | 72 hours |
| Maximum concentration (Cmax) | 72 hours |
| Time of occurrence of maximum concentration (Tmax) | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Adolescents ≥12 to <17 years of age (Cohort 1): area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) | 72 hours |
| Children ≥6 to <12 years of age (Cohort 2): AUC of the Faces-Pain-Scale (FPS)-Revised pain intensity scores | 72 hours |
| Children ≥3 to <6 years of age (Cohort 3): AUC of the Faces, Legs, Activity, Cry, Consolability (FLACC) scale pain intensity scores | 72 hours |
| Total postoperative opioid consumption (in IV morphine milligram equivalents) | 72 hours |
| Proportion of subjects who are opioid-free | 72 hours |
| AUC of the Numeric Rating Scale pain intensity scores at rest (NRS-R) | 72 hours |
| Proportion of subjects who do not receive an opioid prescription at discharge. | 72 hours |
Outcome results
None listed