Postoperative Pain
Conditions
Keywords
postoperative pain, opioid, transdermal
Brief summary
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72 hours during which time supplemental analgesic medication (intravenous morphine PCA) will be provided to all subjects in addition to study drug.
Detailed description
Buprenorphine is a synthetic opioid analgesic with over twenty-five 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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.
Interventions
Sponsors
Purdue Pharma LP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* underwent any major orthopedic surgical procedure requiring general anesthesia, and were expected to be hospitalized \>/=4 days postoperatively. * in moderate or greater pain post-recovery from anesthesia and were expected to be in, or greater than, moderate pain, without analgesics, for \>/=4 days post-surgery.
Exclusion criteria
* receiving chronic opioid therapy preoperatively for \>1 month that was at a total daily dose of \>/= 60 mg of oral morphine equivalents. * have significant concurrent pulmonary conditions. Other protocol-specific exclusion/inclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentrations of buprenorphine at hours 0, 2, 4, 6, 12, 24, 30, 36, 48, 54, 60, 72, 78, or at early termination | — |
| elicited opioid side effects | — |
| pulmonary function tests (O2 saturation, peak flow, forced expiratory volume, forced vital capacity, respiratory rate, and respiratory depression/hypoxia) | — |
| adverse events | — |
| application site skin observations | — |
| clinical laboratory tests | — |
| vital signs | — |
| physical examinations | — |
| electrocardiograms | — |
Secondary
| Measure | Time frame |
|---|---|
| acceptability of therapy | — |
| quality of sleep | — |
| rescue dose usage | — |
| pain intensity | — |
Countries
United States
Outcome results
None listed