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Local Anesthetic/Nonsteroidal Anti-inflammatory Drug (NSAID)

HTX-011 for Pain Relief After Surgery

Phase 4
Waitlist Available
Research Sponsored by Heron Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests a new drug (HTX-011) against an existing one (bupivacaine HCl) for shoulder and tummy surgery.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects may include reactions related to local anesthetics like bupivacaine (e.g., numbness, tingling), NSAIDs (e.g., stomach issues, allergic reactions), acetaminophen (e.g., liver damage at high doses), and general post-surgical risks such as infection.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am scheduled for a corrective surgery.
Select...
I am allergic or have had bad reactions to certain pain medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2018 Phase 3 trial • 418 Patients • NCT03237481
18%
Nausea
17%
Constipation
15%
Dizziness
13%
Headache
9%
Bradycardia
9%
Dysgeusia
8%
Skin odour abnormal
4%
Tremor
4%
Vomiting
2%
Tinnitus
1%
Incision site haematoma
1%
Chronic obstructive pulmonary disease
1%
Gamma-glutamyltransferase increase
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment Group 1: HTX-011
Treatment Group 2: Bupivacaine HCI
Treatment Group 3: Saline Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen
FDA approved
Acetaminophen
FDA approved
HTX-011
2019
Completed Phase 4
~2590
Luer lock applicator
2019
Completed Phase 4
~320

Find a Location

Who is running the clinical trial?

Heron TherapeuticsLead Sponsor
27 Previous Clinical Trials
6,096 Total Patients Enrolled
~22 spots leftby Nov 2025
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