NCT02200016已完成4 期
Displacement of Popliteal Sciatic Nerve Catheters After Major Foot and Ankle Surgery
Kolding Sygehus2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年11月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Frequency of nerve catheter displacement
研究概览
简要总结
Displacement of popliteal sciatic nerve catheters after major foot and ankle surgery. A randomized controlled double blinded MRI study comparing long versus short axis catheter placement. Which procedure for insertion of nerve catheters for postoperative pain after major foot and ankle surgery is the best
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 y.
- •Major foot and ankle surgery postoperativ pain treatment with sciatic nerve catheter r
- •Written and informed concent
排除标准
- •Patient uanble to cooperate
- •Patients not speaking and understanding Danish or English
- •Patiens in immunosuppresive treatment
- •Patienter with neuropathys in lower extremities
- •Allergies to the in the protocole listes medicines
- •A daily opoid intake
- •Pregnant women
- •Patients not meeting MR-criterias (metal, claustofobia...)
结局指标
主要结局
Frequency of nerve catheter displacement
时间窗: 48 hours after catheter placement
次要结局
- Opioid comsumption(Within first 48 hours postoperatively)
- Number of rescue blocks(Within 48 hours postoperatively)
- Postoperativ pain after local anesthetic injection via sciatic nerve catheter(Within 48 hours postoperatively)
- MR evaluated distribution of local anesthetic after injection MR-contrast(48 hours after catheter placement)
研究者
Rasmus Wulff Hauritz
Consultant
Kolding Sygehus
研究点 (2)
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Which procedure for insertion of nerve catheters for postoperative pain after major foot and ankle surgery is the bestThe medical condition to be examined in this study, is postoperative pain after major foot and ankle surgery. Which way to insert a sciatic nerve catheter to treat postoperative pain is the most efficient and give the lowest rate of displacementMedDRA version: 17.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865MedDRA version: 17.0Level: LLTClassification code 10038286Term: Regional nerve blockSystem Organ Class: 100000004865EUCTR2014-000707-28-DKAarhus University Hospital
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