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Local Anesthetic

HTX-011 for Postoperative Pain

Phase 2
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 120 hours
Awards & highlights

Study Summary

This trial is testing a new treatment for people undergoing lumbar decompression surgery.

Eligible Conditions
  • Postoperative Pain
  • Lumbar Laminectomy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 120 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 120 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Serious Adverse Events
Secondary outcome measures
Apparent terminal half-life (t½)
Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf)
Area under the concentration-time curve from Time 0 to the time of last quantitative concentration (AUClast)
+2 more

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

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3: HTX-011Experimental Treatment2 Interventions
HTX-011 (bupivacaine/meloxicam) via application into the surgical site.
Group II: Cohort 2: HTX-011Experimental Treatment2 Interventions
HTX-011 (bupivacaine/meloxicam) via application into the surgical site.
Group III: Cohort 1: Bupivacaine HClExperimental Treatment1 Intervention
Bupivacaine HCl without epinephrine, via injection into the surgical site.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine HCI without epinephrine
2022
Completed Phase 2
~40
HTX-011
2019
Completed Phase 4
~2390
Luer Lock Applicator
2019
Completed Phase 3
~180

Find a Location

Who is running the clinical trial?

Heron TherapeuticsLead Sponsor
27 Previous Clinical Trials
6,154 Total Patients Enrolled
11 Trials studying Postoperative Pain
2,819 Patients Enrolled for Postoperative Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
HTX-011 in Spinal Surgery
2022. "HTX-011 in Spinal Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04911062.
~11 spots leftby Apr 2025
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