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A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.

A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Total Shoulder Arthroplasty (TSA)

NCT06109415•Heron Therapeutics

View on ClinicalTrials.gov

Summary

This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing Total Shoulder Arthroplasty (TSA) (Cohort 1).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
•Is scheduled to undergo a unilateral Total Shoulder Arthroplasty.

Exclusion Criteria

•Is undergoing a revision surgery.
•Has a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to bupivacaine (or other local anesthetics), NSAIDs, acetaminophen, oxycodone, morphine, or hydromorphone.
•History of severe allergic reaction to aspirin or other NSAIDs, or known history of severe gastrointestinal adverse reactions associated with NSAID use.
•Has taken meloxicam within 10 days prior to the scheduled surgery, or any NSAID within 24 hours prior to the scheduled surgery, with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection.
•Opioid use for most days within the last 3 months prior to Screening in the opinion of the Investigator.
•Has been administered immediate-release bupivacaine HCl within 5 days prior to the scheduled surgery, or a modified-release bupivacaine product within 14 days prior to the scheduled surgery.
•Has initiated treatment with any of the following medications within 1 month prior to study drug administration: selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors, gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 inhibitors.
•Has been administered systemic steroids within 5 half-lives or 10 days prior to the scheduled surgery (whichever is longer).
•Has a known or suspected history of drug abuse, a positive drug screen (except for cannabinoids) on the day of surgery, or a history of alcohol abuse within the past 5 years.
•Suspected or confirmed active coronavirus disease 2019 (COVID-19) infection.
+3 more criteria

Locations (5)

Woodland International Research Group, LLC

Little Rock, Arkansas, United States

Center for Orthopaedic Reconstruction and Excellence

Jenks, Oklahoma, United States

First Surgical Hospital

Bellaire, Texas, United States

Legent Orthopedic Hospital

Carrollton, Texas, United States

JBR Clinical Research

Salt Lake City, Utah, United States

Key Dates

Start Date

October 20, 2021

Primary Completion Date

July 18, 2022

Completion Date

July 29, 2022

Last Updated

October 31, 2023

Enrollment

ACTUAL participants

Conditions

Postoperative PainTotal Shoulder ArthroplastyMultimodal Analgesia

Interventions

HTX-011

DRUG

Bupivacaine Hydrochloride

DRUG

Ibuprofen

DRUG

Acetaminophen

DRUG

Luer lock applicator

DEVICE

Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement

NCT06143306

Total Shoulder Arthroplasty

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RECRUITINGNA

QIPB in Inguinal Hernia

NCT06862609

Postoperative Pain

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RECRUITINGNA

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

NCT07436806

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: October 31, 2023Data 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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A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE.

Inclusion Criteria

Exclusion Criteria

Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement

QIPB in Inguinal Hernia

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

Ultrasound-Guided Transversus Abdominis Plane Block Versus Epidural Block for Umbilical Hernia Analgesia

Sacral ESPB vs. PENG Block for Hip Hemiarthroplasty Analgesia

Timing of Subcostal TAPB Combined With Rectus Sheath Block for Postoperative Pain After Laparoscopic Cholecystectomy