A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Active Control Study to Evaluate the Safety and Efficacy of a Single Intraoperative Administration of SKY0402 For Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty (TKA)

NCT00745290 Phase 3 COMPLETED Results posted

The primary objective is to demonstrate that SKY0402 is superior when compared to bupivacaine HCl in the management of postoperative pain for patients undergoing total knee arthroplasty.

Details

Lead sponsor	Pacira Pharmaceuticals, Inc
Phase	Phase 3
Status	COMPLETED
Enrolment	245
Start date	2008-08
Completion	2009-02

Conditions

• Postoperative Pain

Interventions

• Bupivacaine HCl
• SKY0402

Primary outcomes

• Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores — through 72 hours post surgery
  The subject's pain intensity was assessed with activity (NRS-A), while actively flexing the involved knee from the maximum extension point to the maximum flexion point possible. The subject responded to the following question, "On a scale of 0 to 10, where 0 = no pain and 10 = worst possible pain, how much pain did you have while bending your knee?"

Countries

United States