WALANT (Wide Awake Local Anaesthesia With No Tourniquet) Procedure in Carpal Tunnel Release: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Evaluation of the patient's pain intraoperatively at the surgical site.
研究概览
简要总结
The possible benefits expected from the use of the WALANT procedure are a decrease in intraoperative pain at the surgical site, a decrease in hospitalization time, and a decrease in the time required to lift the anesthesia postoperatively.
The risks identified are those inherent to each type of anesthesia (WALANT or traditional ALR), as encountered in current practice, and are therefore not specific to the study: risks related to the local anesthetic agent or risks related to the puncture procedure.
The main objective is to determine whether the patient's intraoperative pain at the surgical site is less after a WALANT procedure compared to a traditional ALR procedure (axillary or trunk).
详细描述
Median nerve neurolysis at the carpal tunnel is one of the most performed procedures in the world. The use of loco-regional anesthesia (LRA) is common practice for this surgery, especially since the use of ultrasound guidance, which allows visualization of the nerves and control of the injection of anesthetic products, makes it a safe technique. The nerve blocks most commonly used in hand surgery are axillary blocks and truncal blocks. The choice between these two techniques, which are equivalent in terms of effectiveness and duration of anesthesia, depends in practice on the habits of each practitioner. As the use of a pneumatic tourniquet during the operation is systematic, the axillary block, by anaesthetizing the whole arm, avoids the discomfort described by some patients when using a tourniquet. For others, the discomfort is related to the sensation of a "dead arm" with a duration of anesthesia of several hours, which the truncular block makes it possible to avoid.
Recently, an alternative to traditional LRA by local anesthesia without tourniquet and without sedation (WALANT procedure: Wide Awake Local Anesthesia with No Tourniquet) has been described. Several studies show the efficacy and safety of this procedure, which is already used in current practice.
However, to date, there is no comparative study evaluating the effectiveness of the WALANT procedure compared to traditional hand surgery techniques for carpal tunnel, neither published nor in progress. This is the purpose of this study.
The WALANT technique, performed under ultrasound, includes two punctures.
- The first is a puncture through a medial approach above the wrist and includes two injections. A first subcutaneous injection reproducing a bar above the wrist flexion line, and a second injection above the median nerve. The volumes injected vary from 8 to 10 milliliters (ml).
- The second puncture is performed at the base of the palmar surface of the hand and consists of a 10 ml subcutaneous injection of the local anesthetic in order to take advantage of the vasoconstrictive effects of adrenaline, thus allowing the surgical procedure to be performed without a pneumatic tourniquet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient over 18 years of age
- •Membership in a mandatory health insurance plan
- •Patient treated for a first median nerve liberation surgery at the carpal tunnel
- •Patient having been informed of the study and having given informed consent
- •French-speaking patient
排除标准
- •Surgical revision
- •Contraindication(s) to loco-regional anesthesia :
- •Coagulation disorder or ongoing anticoagulant therapy
- •Existing peripheral neuropathy
- •Amide-type AL allergy
- •Pregnant or breastfeeding women
- •Inability to undergo the medical follow-up of the study for geographical, social or psychological reasons
- •Patients under legal protection
- •Patients under the influence of drugs that may interfere with the anesthetic techniques under study (cocaine, cannabis, etc. as judged by the investigator)
- •Inclusion of the subject in another research protocol during this study
结局指标
主要结局
Evaluation of the patient's pain intraoperatively at the surgical site.
时间窗: Within 24 hours after intervention
Evaluation of the patient's pain, at the level of the operative site by a visual analog scale from 0 to 10 where 0 equals to "No Pain" and 10 equals to "Extremely severe pain".
次要结局
- Visual Analog Scale for intraoperative pain at the surgical site(intraoperative)
- Evaluation of the hospitalization length.(Within 24 hours after intervention)
- Satisfaction scores(One day after intervention)
- Evaluation of the return to work after surgery(Six months after intervention)
- Evaluation of the safety of different types of anesthesia.(One month after intervention)
- Assessment of the patient's overall pain after surgery(Six months after intervention)
- Evaluation of the quality of life(Six months after intervention)
- Evaluation of the use of analgesics in the postoperative situation(One day after intervention)
- Evaluation of the operative time.(During surgery)
- Evaluation of the failure rates of different anesthesia procedures.(Within 24 hours after intervention)
- Evaluation of the time to release of anesthesia.(Within 24 hours after intervention)