Conditions: Postoperative Pain
Keywords: Postoperative Pain Bunionectomy Analgesia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 58
Healthy volunteers: no

Brief summary:
The primary objective of this study was to determine the appropriate dose of SKY0402 administered as a nerve block for the management of postoperative pain following bunionectomy.

Detailed description:
This Phase 2, multicenter, randomized, double blind, dose escalating/de-escalating study evaluated the safety, efficacy, and pharmacokinetics of a single dose of SKY0402 compared to a single 125 mg dose of bupivacaine HCl for the treatment of postoperative pain in subjects undergoing bunionectomy.

Up to 88 subjects were to be randomized in five consecutive cohorts. The dose of bupivacaine HCl (125 mg) was to remain constant for all cohorts. After completion of Cohort 1, the decision to increase or decrease the dose of SKY0402 was made by a Cohort Data Review Committee following a review of pharmacokinetic, safety, and selected efficacy data from the previous cohort.

Study drug was to be administered as an ankle block, with or without a tourniquet, between 1 hour before the induction of general anesthesia and 20 minutes before the end of general anesthesia. The ankle block procedure consisted of five injections via three skin entries targeting the following nerves: posterior tibial, sural, deep peroneal, superficial peroneal, and saphenous.

The use of intravenous fentanyl during general anesthesia was permitted, but was not to exceed 250 micrograms. The intraoperative use of morphine was prohibited. Postoperatively, subjects had access to both opioid and non-opioid supplemental pain medication under general guidelines. Blood samples for the determination of plasma bupivacaine concentrations were obtained at Baseline and at specified time points through 96 hours.

Arms:
arm 1: Low-dose (175 mg), low-mid dose( 225 mg), and mid-dose (350 mg) arm 2: Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402

Interventions: intervention 1: SKY0402 intervention 2: Bupivacaine HCl
Intervention descriptions: intervention 1: Single dose of SKY0402 administered as a nerve block intervention 2: Single dose of 125 mg administered as a nerve block

Protocol document: