Pediatric Postoperative Analgesia Herniorrhaphy Study

NCT ID: NCT03922048

Last Updated: 2023-06-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2025-12-31

Brief Summary

This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cohort 1 Part A: HTX-011

Adolescents ≥12 to \<17 years of age. A single dose of HTX-011 via instillation into the surgical site.

Group Type: EXPERIMENTAL

HTX-011

Intervention Type: DRUG

Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.

Luer Lock Applicator

Intervention Type: DEVICE

Applicator for instillation.

Cohort 1 Part A: bupivacaine HCl

Adolescents ≥12 to \<17 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site.

Group Type: ACTIVE_COMPARATOR

Bupivacaine HCl

Intervention Type: DRUG

Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).

Cohort 1 Part B: HTX-011

Adolescents ≥12 to \<17 years of age. Dose to be determined from Cohort 1 Part A.

Group Type: EXPERIMENTAL

HTX-011

Intervention Type: DRUG

Dose to be determined from Cohort 1 Part A.

Luer Lock Applicator

Intervention Type: DEVICE

Applicator for instillation.

Cohort 1 Part B: bupivacaine HCl

Adolescents ≥12 to \<17 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site

Group Type: ACTIVE_COMPARATOR

Bupivacaine HCl

Intervention Type: DRUG

Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).

Cohort 2 Part A: HTX-011

Children ≥6 to \<12 years of age. Dose to be determined from Cohort 1.

Group Type: EXPERIMENTAL

HTX-011

Intervention Type: DRUG

Dose to be determined from Cohort 1.

Luer Lock Applicator

Intervention Type: DEVICE

Applicator for instillation.

Cohort 2 Part A: bupivacaine HCl

Children ≥6 to \<12 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site

Group Type: ACTIVE_COMPARATOR

Bupivacaine HCl

Intervention Type: DRUG

Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).

Cohort 2 Part B: HTX-011

Children ≥6 to \<12 years of age. Dose to be determined from Cohort 1.

Group Type: EXPERIMENTAL

HTX-011

Intervention Type: DRUG

Dose to be determined from Cohort 1.

Luer Lock Applicator

Intervention Type: DEVICE

Applicator for instillation.

Cohort 2 Part B: bupivacaine HCl

Children ≥6 to \<12 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site

Group Type: ACTIVE_COMPARATOR

Bupivacaine HCl

Intervention Type: DRUG

Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).

Cohort 3: HTX-011

Children ≥3 to \<6 years of age. Dose to be determined from Cohorts 1 and 2.

Group Type: EXPERIMENTAL

HTX-011

Intervention Type: DRUG

Dose to be determined from Cohorts 1 and 2.

Luer Lock Applicator

Intervention Type: DEVICE

Applicator for instillation.

Cohort 3: bupivacaine HCl

Children ≥3 to \<6 years of age. A single dose of bupivacaine HCl 0.25% (without epinephrine) via injection into the surgical site

Group Type: ACTIVE_COMPARATOR

Bupivacaine HCl

Intervention Type: DRUG

Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).

Interventions

HTX-011

Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.

Intervention Type: DRUG

Bupivacaine HCl

Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).

Intervention Type: DRUG

HTX-011

Dose to be determined from Cohort 1.

Intervention Type: DRUG

HTX-011

Dose to be determined from Cohorts 1 and 2.

Intervention Type: DRUG

HTX-011

Dose to be determined from Cohort 1 Part A.

Intervention Type: DRUG

Luer Lock Applicator

Applicator for instillation.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Has had a prior ipsilateral inguinal herniorrhaphy.
• Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
• Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
• Has taken long-acting opioids within 3 days prior to the scheduled surgery.
• Has taken any opioids within 48 hours prior to the scheduled surgery.
• Has initiated treatment with study 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 undergone 3 or more surgeries within 12 months.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heron Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HTX-011-216

Identifier Type: -

Identifier Source: org_study_id