Conditions: Postoperative Pain
Keywords: pain postoperative total knee arthroplasty analgesia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 138
Healthy volunteers: no

Brief summary:
Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee arthroplasty

Detailed description:
This is a phase 2, multicenter, parallel-group, active-control, randomized, double-blind, dose-ranging study conducted to evaluate three dose levels of SKY0402 compared with 150 mg of bupivacaine HCl.

Arms:
arm 1: Bupivacaine HCl (Marcaine 0.25% with epinephrine 1:200,000) arm 2: SKY0402 at various dosage levels. Single administration.

Interventions: intervention 1: Bupivacaine HCl intervention 2: SKY0402
Intervention descriptions: intervention 1: 150 mg Bupivacaine HCl intervention 2: 600 mg SKY0402 (study drug)

Protocol document: