Postoperative Pain
Conditions
Keywords
Postoperative pain, opioid, transdermal, TKA (total knee arthroplasty)
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.
Interventions
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
DRUGPlacebo BTDS
Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear.
Sponsors
Purdue Pharma LP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Males and females of 18 to 80 years of age with American Society of Anesthesiologists (ASA) physical status classification of 1, 2 or 3 * Scheduled to undergo unilateral total knee arthroplasty (TKA) for the treatment of the osteoarthritis.
Exclusion criteria
* Subjects who have pain or disability in a site other than the operative joint. * Subjects who have had total knee arthroplasty within 6 months of the scheduled surgery or are scheduled to undergo bilateral knee arthroplasty. * Subjects whose body mass index (BMI) is 40 or more.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) as a Measure of Safety | From signed informed consent to 7 days after end of study (approx. 35 days) | Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved. |
Countries
United States
Participant flow
Recruitment details
Study start date: 02-Nov-2006 (first patient first visit) to 20-Apr-2007 (last patient last visit) at 5 medical/research centers in the US. The study was terminated early due to reasons unrelated to efficacy or safety.
Pre-assignment details
Enrolled: N = 14. Following surgery and recovery from anesthesia, subjects had to demonstrate moderate to severe pain within 6 hours postsurgery (Pain Right Now rating of ≥ 2 on a 4-point scale where 0 = no pain and 3 = severe pain), then their intravenous patient-controlled analgesia morphine device was activated. N = 10 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo transdermal patch applied for 7-day wear | 2 |
| BTDS 10 Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear | 3 |
| BTDS 20 Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear | 3 |
| BTDS 30 Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear | 2 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | BTDS 10 | BTDS 20 | BTDS 30 | Total |
|---|---|---|---|---|---|
| Age Continuous | 67 years STANDARD_DEVIATION 8.49 | 58.3 years STANDARD_DEVIATION 7.37 | 66.3 years STANDARD_DEVIATION 4.04 | 59 years STANDARD_DEVIATION 7.07 | 62.6 years STANDARD_DEVIATION 6.87 |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 2 / 3 | 3 / 3 | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 | 0 / 3 | 0 / 2 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Adverse Events that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or SAEs occurring up to 30 days following the last study visit were followed until the AE resolved.
Time frame: From signed informed consent to 7 days after end of study (approx. 35 days)
Population: The Safety Population consisted of subjects who were randomized, received at least 1 dose of double-blind study drug and had at least 1 safety assessment during double-blind treatment.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (AEs) as a Measure of Safety | All Other Adverse Events in ≥ 4.5% of subjects | 2 participants | — |
| Placebo | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Serious Adverse Events | 0 participants | — |
| Placebo | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Deaths | 0 participants | 0 |
| BTDS 10 | Number of Participants With Adverse Events (AEs) as a Measure of Safety | All Other Adverse Events in ≥ 4.5% of subjects | 2 participants | — |
| BTDS 10 | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Serious Adverse Events | 0 participants | — |
| BTDS 10 | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Deaths | 0 participants | 0 |
| BTDS 20 | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Deaths | 0 participants | 0 |
| BTDS 20 | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Serious Adverse Events | 0 participants | — |
| BTDS 20 | Number of Participants With Adverse Events (AEs) as a Measure of Safety | All Other Adverse Events in ≥ 4.5% of subjects | 3 participants | — |
| BTDS 30 | Number of Participants With Adverse Events (AEs) as a Measure of Safety | All Other Adverse Events in ≥ 4.5% of subjects | 2 participants | — |
| BTDS 30 | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Serious Adverse Events | 0 participants | — |
| BTDS 30 | Number of Participants With Adverse Events (AEs) as a Measure of Safety | Deaths | 0 participants | 0 |