Ultrasound Guided Repositioning of a New Suture-method Catheter for Adductor Canal Block - a Randomized Study in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Successful repositioning
研究概览
简要总结
This is a randomized clinical trial in healthy volunteers. 12 volunteers will have suture-method catheters placed in the adductor canal of each leg using the long-axis plane and short-axis plane technique. The investigators will inject LA in both catheters to confirm correct position. Following return of cold sensation the catheter is then displaced intentionally. The orifice is identified by injection of isotonic saline to ensure a proper displacement (spread outside of the adductor canal) and the distance from the delivery orifice of the catheter to the adductor canal is noted. A second investigator will assess distance from the LA delivery orifice of the catheter to the adductor canal using hydrodissection with isotonic saline to pinpoint the delivery orifice and subsequently reposition the catheter to obtain LA spread within the adductor canal. Successful repositioning is defined as a combination of LA spread within the adductor canal and loss of cold sensation on the medial part of the lower leg.
详细描述
The study objective is to investigate whether it is possible to reposition a displaced suture-method catheter using ultrasound.
A peripheral nerve catheter will be inserted on each side under US guidance. An investigator will insert one catheter in the short-axis plane of the adductor canal using an in plane technique: The needle is inserted through the vastus medialis into the adductor canal and exits superficial to the femoral artery through the sartorius muscle.
The second catheter is inserted from proximal to distal direction in the long-axis plane using a combination of in-plane and out-of-plane techniques.
10mL of isotonic saline is used for hydro-dissection for both catheter insertions to facilitate placement. Both catheters are injected with 15 mL LA with an immediate assessment of the spread being within or outside the adductor canal.
Loss of cold sensation in the cutaneous saphenous nerve innervation area will be evaluated 15 minutes after injection by another investigator, who is blinded to allocation and randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The volunteers are randomized using sealed opaque envelopes with a 1:1 ratio. The randomization defines which leg to be used for insertion of a catheter in the long-axis plane and which leg to be used for insertion in the short-axis plane of the adductor canal. Furthermore the randomization defines whether dislocation is executed in the direction of the entry or exit site. The envelopes are prepared by health personnel with no relation to the study and are based on a computer-generated randomization list.
Investigator 2, evaluating loss of sensation to cold, will be blinded to insertion technique and direction of dislocation as well as assessments of spread within the adductor canal. Investigators 3+4 are blinded with regard to direction of dislocation, each other's assessment of spread and to assessments from investigator 1+2. They will be unblinded with regard to insertion technique when they perform US scans
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female ≥18 years of age.
- •ASA classification ≤ II.
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
排除标准
- •Previous surgery or ongoing pain or other disability of investigated region resulting in sensory or neurologic deficits in the investigated region.
- •Allergy to LA.
- •Pregnancy (all female participants will be tested for urine hCG), breastfeeding, or unwilling to practice birth control during participation in the study.
研究组 & 干预措施
SAX catheter insertion
Ultrasound guided cather insertion in the short axis (SAX) of the adductor canal. Injection of lidocaine through the catheter
干预措施: SAX catheter insertion (Procedure)
LAX catheter insertion
Ultrasound guided cather insertion in the long axis (LAX) of the adductor canal. Injection of lidocaine through the catheter
干预措施: LAX catheter insertion (Procedure)
结局指标
主要结局
Successful repositioning
时间窗: 15 min after second injection
Defined as a combination of spread within the adductor canal and loss of cold sensation on the medial part of the lower leg after repositioning and second LA injection. - investigator 3 will evaluate spread and investigator 2 will evaluate cold sensation
次要结局
- Successful primary placement(15 min after first injection)
- Estimation of Limits of Agreement(within 15 minutes, after displacement/repositioning.(recorded by after displacement and repeated just before attempted repositioning))
- Interrater agreement for satisfactory spread within the adductor Canal, (Cohen's Kappa)(recorded immediately after second LA injection)