A Comparison of Ultrasound-Guided and Ultrasound-Guided With Nerve Stimulation Saphenous Nerve Blockade Utilizing the Transsartorial Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Block Success
研究概览
简要总结
Patients undergoing foot and ankle surgery have the option of having a nerve block administered by their Anesthesiologist. The nerve block numbs the foot and results in less post-operative nausea and vomiting, and better pain control. Two different techniques for blocking the saphenous nerve to the foot have been described and are both commonly used at St. Paul's hospital. The goal of this study is to compare the success rates of these two techniques.
详细描述
Purpose / Hypothesis This clinical study is a prospective, controlled, randomized, single-blinded trial designed to investigate the hypothesis that ultrasound-guided blockade of the saphenous nerve in conjunction with nerve stimulation has a higher success rate when compared to ultrasound alone. These research interventions represent what is considered to be an improvement on the standard practice at St. Paul's, which is to block the saphenous nerve with one of any number of saphenous nerve blocks, using a number of different techniques (i.e. ultrasound-guided, nerve stimulation, blind field block); the effectiveness of which has been inconsistent. The purpose of this study is to identify if one technique has a great success rate over another, which would ultimately result in increased success rates of saphenous nerve blocks and patient care.
Study Design The study will be a randomized, single-blinded trial of 80 subjects who are undergoing foot and ankle surgery. Informed consent will be obtained from all study subjects. Subjects will be randomized to one of two saphenous nerve block techniques to be administered by an experienced regional anesthesiologist at St. Paul's Hospital. Once the nerve block is completed the success will be evaluated by an investigator blinded to the procedure. Once the 30min evaluation is completed anesthetic care will be provided according to regular institutional practice and at the discretion of the attending anesthesiologist. The subject will then be contacted at 2 and 7 days after block administration to assess for delayed complications.
Intravenous access will be gained and non-invasive blood pressure measurements will be recorded every five minutes. Continuous electrocardiography and oxygen saturation monitoring will be maintained throughout the procedure and for at least 60 minutes afterwards. Light sedation will be provided, with the goal of maintaining verbal contact with the subject throughout the procedure. Where clinically appropriate, the study block may be preceded by an ultrasound-guided popliteal sciatic nerve block at the discretion of the attending anesthesiologist.
Saphenous nerve blockade will be preformed using a transsartorial approach. Subjects in both groups will be positioned prone. The ultrasound probe will be placed in the transverse plane on the medial aspect of the thigh 3-5cm cephalad to the superior border of the patella (area marked). An attempt will then be made to identify the saphenous nerve, which runs deep to the sartorius muscle within the subsartorial fascial plane. The nerve will appear hyperechoic, round or oval shaped. The anesthesiologist will have a maximum scan time of 3 minutes prior to needle entry. Up to 5 mL of 1% Lidocaine will be used for skin infiltration of the injection site. The block will then be preformed as to the protocols below depending on group allocation. A thirty minute evaluation of the saphenous nerve block will occur during the normal monitoring period after the placement of a block.
Following completion of the thirty-minute evaluation, anesthetic care will be provided according to regular institutional practice and at the discretion of the attending anesthesiologist. This may include spinal or general anesthesia.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects undergoing foot and ankle surgery
- •Normal sensation in saphenous nerve distribution in both legs
- •Provided written informed consent.
- •Body Mass Index <38 kg/m2
排除标准
- •Subject refusal
- •A known history of allergy, sensitivity or any other form of reaction to local anesthetics of amide type
- •Suspected inability to comply with study procedures, including language difficulties or medical history and/or concomitant disease (i.e. skin infection as the site of needle insertion), as judged by the investigator. Reason for exclusion will be recorded.
- •A neurological and/or vascular condition, which may preclude eligibility for peripheral nerve blockade (i.e. peripheral neuropathy) as judged by the investigator. Reason for exclusion will be recorded.
- •Subjects on therapeutic anticoagulation or coagulopathy at the time of nerve blockade.
- •Previous inclusion in this study.
- •Participation in other clinical studies during this study or in the 14 days prior to admission to this study.
- •Surgeon refusal (e.g. the surgeon does not want a nerve block for the subject). Reason for exclusion will be recorded.
结局指标
主要结局
Block Success
时间窗: 30 minutes post nerve block
Complete absence of sensation to pinprick at two different anatomic areas of the saphenous nerve at thirty minutes
次要结局
- Delayed Complications(7 days post operative)
- Any Evidence of Blockade (Decreased or Complete Absence of Sensation)(30 min)
- Incomplete Block Rate(30 minutes post nerve block)
- Speed of Onset for Nerve Block (Complete Blockade)(30 minutes post nerve block)
- Mean Minimum Stimulation Current(5 minutes)
- Rate of Success of Elicitation of a Tapping Sensation(5 minutes)
- Block Failure Rate(30 minutes post nerve block)
- Rate of Success of Elicitation of a Tapping Sensation at < 0.6 Milliampere (mA)(5 minutes)
- Time Required to Administer Block(10 minutes)
- Immediate Complications(60 minutes post block completion)
研究者
Scott Bell
Dr. Scott Bell
University of British Columbia
