Conditions: Postoperative Pain
Keywords: Total knee arthroplasty Pain Analgesia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 245
Healthy volunteers: no

Brief summary:
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.

Detailed description:
The primary objective is to demonstrate the superiority of SKY0402, compared with bupivacaine HC1, with respect to the extent and duration of the analgesic effect achieved by a single intraoperative administration of the study drug via local infiltration in subjects undergoing total knee arthroplasty (TKA).

The secondary objectives are to evaluate additional efficacy parameters and characterize the safety profile of SKY0402 in comparison with bupivacaine HCl.

Arms:
arm 1: Single dose of 200 mg bupivacaine HCl administered intraoperatively via local infiltration arm 2: Single dose of 600 mg SKY0402 (study drug) administered intraoperatively via local infiltration

Interventions: intervention 1: Bupivacaine HCl intervention 2: SKY0402
Intervention descriptions: intervention 1: 200 mg bupivacaine HCl intervention 2: 600 mg SKY0402 (study drug).

Protocol document: