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Phase 2 Herniorrhaphy Study for Opioid Elimination

NCT03695367 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-03-02

Study results available
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Summary

This is a Phase 2, open-label study in subjects undergoing unilateral open inguinal herniorrhaphy.

Conditions

  • Postoperative Pain

Interventions

DRUG

HTX-011

HTX-011 (bupivacaine/meloxicam), 300 mg/ 9 mg via instillation.

DEVICE

Luer lock applicator

Applicator for instillation.

DEVICE

Vial access device

Device for withdrawal of drug product.

DRUG

Ibuprofen

Ibuprofen, 600 mg.

DRUG

Acetaminophen

Acetaminophen, 1 g.

DRUG

Ketorolac

Intraoperative IV ketorolac.

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Principal Investigators

  • Neil Singla, MD · Lotus Clinical Research, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2018-11-20
Completion
2018-12-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03695367 on ClinicalTrials.gov