Conditions: Postoperative Pain
Keywords: Postoperative pain opioid transdermal TKA (total knee arthroplasty)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: no

Brief summary:
The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug.

Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became safety evaluations.

Detailed description:
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Arms:
arm 1: Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear arm 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear arm 3: Buprenorphine transdermal patch 30 mcg/h applied for 7-day wear arm 4: Placebo patches were similar to BTDS 10 and 20.

Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Buprenorphine transdermal patch intervention 3: Buprenorphine transdermal patch intervention 4: Placebo BTDS
Intervention descriptions: intervention 1: Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear. intervention 2: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear. intervention 3: Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear. intervention 4: Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear.

Protocol document: