NCT01012232已完成4 期
The Volume-concentration Relationship of Analgesic Efficacy With Intra-capsular Local Anesthetic in Total Knee Arthroplasty: a Randomized, Double-blind, Cross-over Trial.
Lundbeck Foundation1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- postoperative pain
研究概览
简要总结
In a randomized, double-blind, cross-over trial, 48 patients scheduled for total knee arthroplasty with placement of an intracapsular catheter will be randomized to receive bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) or low volume/high concentration (10 mL, 10 mg/mL) 6 and 24 hours postoperatively, and pain will be assessed at rest and with mobilization for 2 hours after injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for total knee arthroplasty
- •Able to give informed oral and written consent to participate
排除标准
- •Treatment with opioids or steroids, rheumatoid arthritis or other immunological diseases
- •History of stroke or any neurological or psychiatric disease potentially influencing pain perception (e.g. depression, diabetic neuropathy etc.)
- •Allergies to any of the drugs administered.
研究组 & 干预措施
low volume local anesthetic
Active Comparator
bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL)
干预措施: 10 mL ropivacaine 10 mg/mL (Drug)
high volume local anesthetic
Experimental
bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL)
干预措施: 20 mL ropivacaine 5 mg/mL (Drug)
结局指标
主要结局
postoperative pain
时间窗: 32 hours postoperative
次要结局
未报告次要终点
研究者
研究点 (1)
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