Herniorrhaphy Study for Opioid Elimination

Heron Therapeutics

Status and phase: Completed; Phase 3

Conditions: Analgesia

Treatments: Device: Luer lock applicator; Drug: Ibuprofen; Drug: Acetaminophen; Drug: HTX-011

Study type: Interventional

Funder types: Industry

Identifiers

NCT03907176

HTX-011-304

Details and patient eligibility

About

This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal analgesic (MMA) regimen. The study will be conducted in 2 sequential parts: Part 1 is randomized and Part 2 is Investigator's preference for MMA regimen.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is scheduled and medically fit to undergo an elective unilateral open inguinal herniorrhaphy with mesh under deep sedation or general anesthesia; no neuraxial technique (eg, no spinal or epidural).
• Has an American Society of Anesthesiologists (ASA) 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 planned concurrent surgical procedure (eg, bilateral 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 a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
• Part 1 only: Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. Part 2 only: Has known or suspected history of persistent opioid use, defined as daily, or almost daily, use of opioids for a period of at least 30 days within the previous 6 months.
• Has taken any opioids within 24 hours prior to the scheduled surgery.
• 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 uncontrolled anxiety, psychiatric, or neurological disorder.
• Has a known or suspected history of drug abuse, has a positive drug screen on the day of surgery, consumes 3 or more alcoholic drinks every day, or has a recent history of alcohol abuse.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

Cohort 1

Experimental group

Description:

HTX-011; Ibuprofen and Acetaminophen (regimen 1)

Treatment:

Drug: Ibuprofen

Drug: HTX-011

Drug: Acetaminophen

Device: Luer lock applicator

Cohort 2

Experimental group

Description:

HTX-011; Ibuprofen and Acetaminophen (regimen 2)

Treatment:

Drug: Ibuprofen

Drug: HTX-011

Drug: Acetaminophen

Device: Luer lock applicator