Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Prolonged pain after arthroplastic surgery
研究概览
简要总结
Buprenorphine is a highly lipophilic thebaine derivative that appears to have high affinity for mu-, kappa-, and delta-opioid receptors and low affinity for opioid receptors like 1 -receptors. It acts as a partial agonist at the mu-opioid and as a partial agonist/antagonist at the kappa-opioid, and as an antagonist at the delta opioid receptors. Buprenorphine has up to two-fold duration of action and it is approximately 30-fold more potent when compared to morphine.
Pain is a common problem in patients coming to joint arthroplastic surgery. Buprenorphine low dose patches are recommended for treatment of moderate pain for example osteoarthritis pain. It is known that well treated pain even preoperatively may prevent prolonged postsurgical pain.
In the present study the effects of low dose buprenorphine on postoperative pain and recovery were assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no pregnancy/lactation, reliable contraception before menopause
- •elective knee or hip arthroplasty surgery
- •BMI (=body mass index) 18-35 kg/m2
- •obtained informed consent
排除标准
- •buprenorphine medication
- •allergy to study drugs• ikä < 18 tai >75 years
- •BMI <18 tai>35 kg/m2
- •weight below 50 kg
- •Other contraindication for the study drug
研究组 & 干预措施
Buprenorphine
Buprenorphine 5 microg/h/7days patch
干预措施: Buprenorphine (Drug)
Placebo
Placebo patch
干预措施: Placebo (Drug)
结局指标
主要结局
Prolonged pain after arthroplastic surgery
时间窗: from time from drug patch administration up to one year
Brief pain inventory
Pain relief
时间窗: time from drug patch administration up to five weeks
Brief pain inventory
次要结局
未报告次要终点
研究者
Merja Kokki
MD, PhD
Kuopio University Hospital