Post Operative Analgesia After Wrist Fracture Surgery Under Regional Anesthesia: Randomized Trial, Open Study, With Evaluation of the Endpoint and Patient Blind (PROBE Design), Evaluating the Equivalence Between Ultrasound-guided Nerve Bloc and Local Infiltration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Mean time interval between the analgesic intervention and the onset of a pain score greater than 3/10 on a Numeric Rating Scale for pain, during the first post operative 48 hours
研究概览
简要总结
Distal radial fracture reparations by volar plating are often managed under regional anaesthesia, but are associated with severe pain when the block ends. Acute post-operative pain may delay rehabilitation, and even be a risk factor for the development of chronic pain. The use of opioids and the inevitable opioid-related side effects further decrease patient satisfaction. A multimodal approach to pain management should include local or regional analgesia technique when possible. In the case of wrist fractures, two methods are available: peripheral nerve block by the anaesthesiologist or surgical site local infiltration by the surgeon with a long-acting local aesthetic. Both techniques are commonly used for the management of postoperative pain after diverse orthopaedic surgeries.
The purpose of this study was to determine the equivalence between ultrasound-guided peripheral nerve block and local infiltration by the surgeon for short-term postoperative analgesia after surgical reparation of isolated closed wrist fractures by volar plating under regional anaesthesia. The quality of postoperative pain, patient satisfaction and adverse events were recorded for the first 48 hours following surgery.
详细描述
Patients were allocated to treatment group according to a computer-generated randomisation sequence by blocs. Randomization was obtained and all data recorded through an electronic report form (URC Robert Debre).
Demographic and medical information were obtained in a pre-operative anaesthesia consultation kept with the rest of the patient's written file.
All interventions were carried out under regional anaesthesia consisting of an ultrasound-guided axillary block with 25-35 mL of lidocaine 1,5% with epinephrine, targeting the median, ulnar, radial, musculocutaneous and lateral cutaneous nerves. The analgesic intervention was realised according to group allocation, at the end of surgery: after skin closure and before making the cast. To ensure the blinding of the patient, the surgical sterile drapes were kept until the end of the analgesic intervention
- In the peripheral nerve block group (BN), the anaesthesiologist performed an ultrasound-guided block of the median and radial nerves at the lower third of the arm. Each nerve was encircled with 10 mL of ropivacaine 0,475%.
- In the local infiltration group (INF), the surgeon injected 10mL of ropivacaine 0,75% directly all peri-fracture tissues: fracture site, tendon synovial sheaths hypodermis and dermis regarding surgical incision.
An operating room or aesthetic nurse timed the duration of realisation of the analgesic intervention.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated closed wrist fracture requiring surgical treatment,
- •ASA (American Society of Anesthesiologists) score I to III,
- •Sufficient level of understanding and expression in french,
- •Recipient of a social security regimen (excluding State Medical Aid)
排除标准
- •Psychological or neurological disorder preventing a correct understanding of the study
- •Insufficient knowledge of french
- •Chronic pain
- •Major analgesic ou psychotropic drug
- •Drug addiction
- •Corticosteroid therapy
- •Diabetic neuropathy
- •Opioid intolerance (confusion, dizziness, severe constipation, nausea and vomiting, urinary retention)
- •Renal or hepatic failure
- •Pregnancy or breastfeeding
- •Unstable hypertension
- •Unstable coronary syndrome
- •Contraindication to NSAIDs (peptic ulcer, severe renal failure)
- •Known hypersensitivity to ropivacaine or other amid-type local anesthetics
- •Open fracture
结局指标
主要结局
Mean time interval between the analgesic intervention and the onset of a pain score greater than 3/10 on a Numeric Rating Scale for pain, during the first post operative 48 hours
时间窗: 48 hours
次要结局
未报告次要终点