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Phase 2 Herniorrhaphy Study for Opioid Elimination | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Phase 2 Herniorrhaphy Study for Opioid Elimination

A Phase 2, Open-Label Study of HTX 011 in a Multimodal Analgesic Regimen for Decreased Opioid Use Following Unilateral Open Inguinal Herniorrhaphy

NCT03695367•Heron Therapeutics

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 except as a child (less than 6 years of age).
•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.
•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 long-acting opioids within 3 days prior to the scheduled surgery.
•Has taken any opioids within 24 hours 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.
+11 more criteria

Locations (5)

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Lotus Clinical Research, LLC

Pasadena, California, United States

JBR Clinical Research

Draper, Utah, United States

JBR Clinical Research

Murray, Utah, United States

JBR Clinical Research

Salt Lake City, Utah, United States

Key Dates

Start Date

October 1, 2018

Primary Completion Date

November 20, 2018

Completion Date

December 15, 2018

Last Updated

March 2, 2026

Enrollment

ACTUAL participants

Conditions

Postoperative Pain

Interventions

HTX-011

DRUG

Luer lock applicator

DEVICE

Vial access device

DEVICE

Ibuprofen

DRUG

Acetaminophen

DRUG

Ketorolac

DRUG

QIPB in Inguinal Hernia

NCT06862609

Postoperative Pain

View study

RECRUITINGNA

SPS Block vs. Surgical Intercostal Block for Chronic Pain After Thoracoscopic Surgery

NCT07436806

Chronic Post-thoracotomy PainNeuropathic Pain+1 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 2 Herniorrhaphy Study for Opioid Elimination

Inclusion Criteria

Exclusion Criteria

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