HTX-011 for Pain Relief After Surgery

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Heron Therapeutics

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical procedures. Each parallel cohort will enroll subjects undergoing a unique surgical procedure: total shoulder arthroplasty (TSA) in Cohort 1 and abdominoplasty in Cohort 2.

Eligibility Criteria

This trial is for individuals scheduled for a unilateral Total Shoulder Arthroplasty or abdominoplasty, with an ASA Physical Status of I-III. Exclusions include recent NSAID use, prior surgeries within specific timeframes, high BMI (>40 kg/m2), drug abuse history, active COVID-19 infection, certain medication use close to surgery, and known allergies to study drugs.

Inclusion Criteria

My health is good to moderately impaired according to ASA standards.

I am scheduled for a shoulder replacement or tummy tuck surgery.

Exclusion Criteria

I am scheduled for a corrective surgery.

I have had a tummy tuck or major surgery on my abdominal wall.

I have not taken meloxicam in the last 10 days or any NSAID in the last 24 hours, except for low-dose aspirin for heart health.

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Treatment Details

Interventions

Acetaminophen (Analgesic)
Bupivacaine Hydrochloride (Local Anesthetic)
HTX-011 (Local Anesthetic/Nonsteroidal Anti-inflammatory Drug (NSAID))
Ibuprofen (Nonsteroidal Anti-inflammatory Drug (NSAID))
Luer lock applicator (Device)

Trial OverviewThe study tests HTX-011 against bupivacaine HCl in patients undergoing shoulder replacement or tummy tuck surgeries. It's randomized and blinded; participants won't know which treatment they receive. The goal is to compare pain relief effectiveness between the two treatments.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Group 1 Cohort 2Experimental Treatment4 Interventions

HTX-011 + MMA

Group II: Treatment Group 1 Cohort 1Experimental Treatment4 Interventions

HTX-011 + multimodal analgesic (MMA) regimen

Group III: Treatment Group 2 Cohort 2Active Control3 Interventions

Bupivacaine HCl + MMA

Group IV: Treatment Group 2 Cohort 1Active Control3 Interventions

Bupivacaine HCl + MMA