Comparison of the Infraclavicular and Axillary Approaches for Continuous Ultrasound-guided Brachial Plexus Block: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Anesthesia score
研究概览
简要总结
Prospective randomized study comparing the axillary and the infraclavicular approaches for continuous brachial plexus block after hand surgery.
详细描述
Regional anesthesia is considered as the gold standard for analgesia and anesthesia of hand surgeries. However, with a single-shot technique, a maximum of 13 hours of analgesia is obtained, even with a long-acting local anesthetic and adjuvants. For painful surgeries necessitating prolonged analgesia of more than 24 hours, continuous regional analgesia techniques have been described, using perinervous catheters. However, these techniques have a high incidence of failure. The most frequent causes of failure are catheter displacements, misplacement, and the distance between the targeted nerves. Many approaches have been described to insert these catheters (axillary, infraclavicular and supraclavicular), but the optimal approach remains unknown. Therefore, international and even local practices vary widely.
Investigators plan to compare the axillary and the infraclavicular approaches in this randomized study, on 60 patients. In every group, an initial bolus will be given and then a perinervous catheter will be inserted by the allocated approach. The surgery will be done under regional anesthesia. The co-analgesia, the local anesthetic infusion and the follow-up will be standardized and will be the same in the two groups.
The primary outcome will be an anesthesia score on 16 points previously described in other similar publication. The primary outcome will be at 24 hours after block realization, but it will be repeated at 48 hours. It will evaluate the degree of sensitive and motor blockade of every major nerve of the hand. Secondary outcomes will be the time, comfort and adverse effects of the technique, and postoperative pain, analgesia, satisfaction and adverse effects.
The aim of this study is to help determine the optimal approach for brachial plexus catheter insertion, in order to improve analgesia, to decrease morphine consumption and its related adverse effects, and to improve patients and caregivers satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Adult patients with a social insurance number
- •Patients undergoing hand surgery requiring a continuous brachial plexus block
- •Elective or urgent surgery
- •Effective contraception (HAS criteria)
- •Informed consent
排除标准
- •Contraindication to the installation of a continuous brachial plexus block (coagulopathy, refusal, allergy to the medication)
- •Preexisting neuropathy
- •Pregnancy
- •Arteriovenous fistula
- •Obesity (BMI >40)
- •Another surgical site implicated during the surgery
- •Incapacity to abduct the operated arm
- •Preoperative use of morphine or equivalent
结局指标
主要结局
Anesthesia score
时间窗: 24 hours after block realization
Min/Max : 0 for no anesthesia to 16 total anesthesia Addition of Motor block score (0-2) and Sensitive block score (0-2) for the 4 main nerves of the hand
次要结局
- Anesthesia score(48 hours after block realization)
- Total morphine consumption(24 and 48 hours after block realization)
- Duration of catheter insertion procedure(During block realization)
- Mean pain at rest and with movement(24 and 48 hours after block realization)
- Quality of sleep(Over first night after block realization)
- Patient satisfaction(48 hours after block realization)
- Maximal pain during the first 24 hours(During the first 24 hours after block realization)
- Maximal pain during the surgery procedure(During surgery)