Postoperative Analgesia After Total Hip Replacement
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- VAS-score for pain at movement and at rest every three hours
研究概览
简要总结
There are several treatments for postoperative pain after Hip Replacement Surgery. However, some require an intravenous line which may interfere with rehabilitation after surgery. This study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery. Patients will either receive pain treatment at surgery, continuous intravenous pain treatment, or both. In the first two days after surgery, patients will frequently be asked to rate their pain, and use of other pain medication will be monitored.
详细描述
This is a three-group randomized placebo-controlled double blind trial to assess which postoperative analgesia is best after total hip replacement. The conventional analgesia includes both intrathecal morphine at surgery and Patient Controlled Analgesia (PCA) with morphine in the first 48 hours after surgery. This will be compared with two experimental groups which will receive either intrathecal morphine and PCA with placebo or intrathecal placebo and PCA with morphine. Escape medication with intramuscular morphine is available in all groups. A total of 120 patients will be randomized.
VAS- score at rest and with movement will be recorded every three hours for the first 48 hours after surgery, as well as PCA-bolussum and Morphine IM.
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
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients accepted for fast-track total hip replacement, i.e.ASA 3 or lower
排除标准
- •Not able to speak dutch
- •communication problems
- •mental retardation
结局指标
主要结局
VAS-score for pain at movement and at rest every three hours
PCA-bolus-sum every three-hour period
Morphine-IM rescue dose every three-hour period
次要结局
- patient satisfaction each 24 hours
- iv-morphine dose needed to attain VAS-score under 40 mm
- PONV every three hours
- urine retention every three hours
- itching every three hours
- decrease in saturation every three hours
- quality of physical training