NCT03015532

Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia

A Phase 2b, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study of HTX-011 Via Infiltration for Postoperative Analgesia in Subjects Undergoing Total Knee Arthroplasty

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: Heron Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-01-13
• Primary completion: 2018-04-20
• Completion: 2018-05-16
• First posted: 2017-01-10
• Last updated: 2026-03-02
• Results posted: 2021-10-27

Locations

24 sites across 1 country: United States