Axillary Block in Association With Analgesic Truncal Blocks of the Median and Radial Nerves at the Elbow for Wrist Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 13
- 主要终点
- Level of pain when the patient recovers the flexion of the forearm on the arm
研究概览
简要总结
Fractures of the forearm bones that occur around the wrist are common in the elderly. Standard anesthesia for its surgical treatment is regional anesthesia (RA): supraclavicular block, infraclavicular block or axillary block (BAX). However, these techniques have some limitations, such as the postoperative pain management and the non-specificity of the analgesia. Indeed analgesia is not specific to the wrist and extends to the elbow and forearm, preventing rapid recovery of elbow flexion and extension when a long-acting local anesthetic (LA) is used. Recently RA techniques associating proximal anesthetic blocks with distal analgesic blocks have been proposed to serve a dual objective: good anesthesia for surgery and specific analgesia.
The hypothesis of this study is that, for the wrist surgery, axillary block using a short-acting LA combined with analgesic blocks at the elbow using a long-acting LA could provide a RA installation time reduction, an optimal surgical comfort, a longer post-operative analgesia duration and a faster recovery from motor block.
详细描述
This multicenter, prospective, randomized, open-Label study compares two techniques :
- BAX (usual technique) : Axillary brachial plexus block (Axillary block) with a long-acting LA (Ropivacaine)
- BAX-Asso (experimental technique) : Axillary brachial plexus block (Axillary block) with a short-acting local anesthetic (Lidocaine) + Analgesic block at the elbow with a long-acting local anesthetic (Ropivacaine) Every block will be performed under Ultrasound. BAX will be performed using a multi-injection technique at contact with median (nM), radial (nR), ulnar (nU), musculocutaneous (nMC) and medial antebrachial cutaneous (nCMAB) nerves. 15-30 mL of LA will be injected.
Analgesic truncal blocks of the median and radial nerves will be performed at the elbow. 3-7 mL of LA will be injected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Patients undergoing wrist fracture surgery under regional anesthesia
- •Consent for participation
- •Affiliation to the French social security system
排除标准
- •Chronic use of opiod analgesics
- •Chronic pain syndrome or fibromyalgia
- •Contraindication for locoregional anesthesia
- •Contraindication for opioid
- •Pregnant or breastfeeding women
- •Patients under protection of the adults (guardianship, curators or safeguard of justice)
- •Communication difficulties or neuropsychiatric disorder
研究组 & 干预措施
BAX
干预措施: Axillary brachial plexus block with a long-acting local anesthetic (Procedure)
BAX
干预措施: Ropivacaine (Drug)
BAX-Asso
干预措施: Lidocaine (Drug)
BAX-Asso
干预措施: Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic (Procedure)
BAX-Asso
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Level of pain when the patient recovers the flexion of the forearm on the arm
时间窗: 24 hours
Pain VRS ranging from 0 to 10 (0=no pain, 10=worst possible pain)
次要结局
- Duration of motor block at the elbow(24 hours)
- Feasibility of the wrist surgery(2 hours)
- Postoperative morphine consumption(48 hours)
- Axillary block success(40 minutes)
- Duration of postoperative analgesia(72 hours)
- Complications during block performance(15 minutes)
- Complications immediately after block(2 hours)
- Postoperative complications(Day 15 After Surgery)
- Sleep quality(Day 2 After Surgery)