Evaluation of Postoperative Experience of Two WALANT-type Modes of Anesthesia (Lidocaine Alone or Combined With Ropivacaine) Used in Ambulatory Surgery of the Upper Limb. A Single-center Prospective Randomized, Single-blind Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Control group: experience of patients in the Lidocaine alone group
研究概览
简要总结
Distal surgery of the upper limb under local anesthesia using the WALANT technique (Wide Awake Local Anesthesia No Tourniquet) has become the standard care in orthopedic surgery. The principle is that the operator infiltrates the whole surgical area with a 1% lidocaine solution combined with adrenaline (diluted to 1/200,000) so that all distal surgery of the upper limb can be performed without a tourniquet. Thus, the perioperative course and management of the patient in the operating room and the constraints inherent to general anesthesia are largely reduced. Also, the material cost is considerably reduced. However, WALANT often induces significant pain when the patient leaves the operating room to return home. This effect is related to the pharmacological formulation of lidocaine which has a short half-life (< 3h). To reduce this inconvenience of early block removal, adding a local anesthetic with a longer duration of action (ropivacaine) to lidocaine would extend the duration of the analgesic, improving postoperative experience and satisfaction. The main objective of this research is to evaluate the effect of two WALANT anesthesia protocols (with or without the addition of ropivacaine) on the postoperative experience of patients (QoR-40 questionnaire) 48 hours after outpatient hand surgery.
详细描述
Secondary objectives include the evaluation of short-term pain (Day 0 to Day 7), chronicisation of pain at 3 months, patient satisfaction regarding perioperative management and tolerance in both groups.
This is a monocentric, prospective, randomized, single-blind study. 80 adult patients, eligible for outpatient surgery under under WALANT for hand surgery such as carpal tunnel, stub finger, Dupuytren's disease or elbow surgery such as ulnar nerve compression and lacertus fibrosus syndrome, will be recruited during their care in the orthopedic and trauma surgery department at Nîmes University Hospital over an estimated period of 12 months. After receiving information, the intervention visit will be planned within 21 days. After collecting consent and checking the selection criteria, patients will be randomized (1:1 stratified according to hand/elbow surgery) for a procedure under WALANT anesthesia with 10 to 20 ml of 1% lidocaine (10 mg/mL) (depending on the procedure) combined with adrenaline (0.005mg/ml) with or without the addition of 15mg ropivacaine. An evaluation of the pain via a visual analog scale (0 to 10) will be carried out before discharge from the service and by telephone on Day 1 according to the current care then at Days 2 and 3 and 7 for the research. The patients will also have to answer questionnaires on their perioperative management (Evaluation of the experience of local anaesthesia or EVAN-LR) before leaving the department and then on the postoperative experience (Quality of Recovery or QoR-40) at D2 and the possible "chronicisation" of pain at 3 months (neuropathic pain or DN4) by telephone. Possible adverse events will be collected up to D7.
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
- Double (Participant, Investigator)
盲法说明
The patient will be blinded to his or her anesthesia protocol. The investigating physician who performs the anesthesia and surgery will be different from the evaluators (IDE, hospital CRA, evaluating physician) who will be blinded to the patient's assignment group.
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
- •Patient eligible for outpatient surgery under WALANT for:
- •Hand surgery such as carpal tunnel, stub finger, Dupuytren's disease;
- •Elbow surgery such as ulnar nerve compression and lacertus fibrosus syndrome.
- •Patient with free and informed consent.
- •Patient with signed consent form.
- •Patient affiliated to or beneficiary of a health insurance plan.
排除标准
- •Ischemic vascular disorders such as severe Raynaud's disease, Buerger's disease, diabetic microangiopathy.
- •Scleroderma.
- •Known allergy to ropivacaine or lidocaine and possibility of cross-allergy with other amide-bound local cross-allergy with other local anesthetics with amide linkage.
- •Severe hepatic impairment
- •Acute porphyria.
- •Intravascular anesthesia.
- •Anesthesia by local infiltration in the extremities
- •Coronary insufficiency.
- •Ventricular rhythm disorders.
- •Severe arterial hypertension.
- •Obstructive cardiomyopathy.
- •Hyperthyroidism.
- •Hypovolemia.
结局指标
主要结局
Control group: experience of patients in the Lidocaine alone group
时间窗: 48 hours after surgery
The postoperative experience will be evaluated by the Quality of Recovery questionnaire (QoR-40) at 48 h postoperative. This questionnaire includes sections on comfort, pain, support, emotions and physical independence. Each section has questions to be answered on a scale of 1 to 5 in which 1 = very poor and 5 = excellent.
Experimental group: experience of patients in the Lidocaine + Ropivacaine group
时间窗: 48 hours after surgery
The postoperative experience will be evaluated by the Quality of Recovery questionnaire (QoR-40) at 48 h postoperative. This questionnaire includes sections on comfort, pain, support, emotions and physical independence. Each section has questions to be answered on a scale of 1 to 5 in which 1 = very poor and 5 = excellent.
次要结局
- Neuropathic pain according to the DN4 questionnaire: Experimental group(At 3 months)
- Pain on a numerical visual analog scale : Experimental group(Day 7)
- Pain on a visual numerical scale : Control group(Day 7)
- Clinical or biological adverse events: Experimental group(From Day 0 to Day 2)
- Clinical or biological adverse events: Control group(From Day 0 to Day 2)
- Satisfaction with perioperative management: Experimental group according to the EVAN-LR questionnaire(Day 0)
- Neuropathic pain according to the DN4 questionnaire: Control group(At 3 months)
- Satisfaction with perioperative management according to the EVAN-LR questionnaire Control group(Day 0)