Catheter Over Needle Technique Causes Less Leakage and Secondary Failure Than Catheter Through Needle Technique for Continuous Femoral Nerve Block
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Catheter leakage
研究概览
简要总结
To randomize 108 patients undergoing knee replacement surgery to catheter through needle or catheter over needle femoral nerve blocks, then monitor the catheters for leakage to see if there is a difference.
详细描述
Background: Total Knee Replacement Surgery is a commonly performed procedure that causes significant post-operative pain. Continuous femoral nerve blocks are widely used for analgesia as part of a multimodal analgesic regimen for this surgery. They provide sustained analgesia which allows early physiotherapy for rehabilitation. Currently the most common technique for inserting catheters for continuous femoral nerve blocks is to feed a catheter though a needle (CTN) which has been placed close by the nerve. There is a significant rate of leak and dislodgement of these catheters which can lead secondary failure where the catheter is no longer providing analgesia by blocking the nerve (primary failure occurs when the nerve block catheter fails to provide any analgesia from the start). The system to be investigated has a catheter over the needle (CON) which is left in place after the needle is withdrawn. The proposed benefit of this is that there will be a reduction in leak rates and dislodgement. This is because using a CON technique means that the biggest hole will be the diameter of the catheter, rather than CTN where the biggest hole will be the diameter of the needle therefore allowing leak around the outside of the catheter.
Objectives: To ascertain whether or not the catheter over needle technique is superior to catheter through needle technique in terms of a leak rate.
Trial plan: To recruit 108 patients who are having total knee replacement surgery into the study and randomise them into having either CON or CTN continuous femoral nerve blocks.
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
- Single (Participant)
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
- •Patients presenting to Sir Charles Gairdner Hospital for elective, unilateral, primary total knee replacement.
- •Body mass index 18-40 kg/m2
- •American Society of Anaesthetists (ASA) grade I-III
排除标准
- •Allergy to local anaesthetic
- •Inability to cooperate
- •Inability to read, speak and understand English
- •Less than 18 years old
结局指标
主要结局
Catheter leakage
时间窗: 2 days post insertion
Any leakage around the catheter insertion site as assessed by visual inspection.
次要结局
- Overall rate of secondary failure as assessed by the acute pain service on days 1 and 2 post op.(2 days)
- Ease of insertion assessed by the inserting anaesthetist on a 5 point Likert scale.(intraoperative)
- Needle visibility assessed by the inserting anaesthetist on a 5 point Likert scale.(intraoperative)
研究者
Richard Edwards
Principle Investigator
Sir Charles Gairdner Hospital