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Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia

NCT03015532 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2026-03-02

Study results available
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Summary

This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgical site.

Conditions

  • Postoperative Pain

Interventions

DRUG

HTX-011

HTX-011 (bupivacaine/meloxicam), via instillation

DRUG

Saline Placebo

Saline placebo via injection

DRUG

Bupivicaine HCl

Bupivacaine HCl without epinephrine

DRUG

Ropivacaine

Ropivacaine, via injection

Sponsors & Collaborators

  • Heron Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-13
Primary Completion
2018-04-20
Completion
2018-05-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03015532 on ClinicalTrials.gov