Retroclavicular Approach vs Infraclavicular Approach for Plexic Bloc Anesthesia of the Upper Limb: a Multi-centric Non-inferiority Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Time of block performance
研究概览
简要总结
Locoregional anesthesia provides several advantages over general anesthesia in terms of postoperative pain, decreased postoperative opioid needs and reduced recovery time for patients undergoing orthopaedic surgery.
For upper limb surgery, the coracoid infraclavicular brachial plexus block is generally preferred because of its simplicity and effectiveness but, needle visibility remains a challenge because of the angle between the ultrasound beam and the needle.
The retroclavicular approach for brachial plexus anesthesia requires an angle between the needle and the ultrasound beam that is less steep than the angle required to perform an infraclavicular coracoid block. This approach has already been proven effective and safe in the past.
The general objective is to provide a formal comparison between the retroclavicular approach and coracoid infraclavicular approach for brachial plexus anaesthesia. This study will delineate the differences between the two techniques.
详细描述
Investigators aim is to compare both techniques in terms of scanning time, needling time, total anesthesia time, needle visibility, block needle passes, block success and early and late complications. Investigators made the hypothesis that, while providing similar efficacy and better needle visualisation than coracoid infraclavicular block, performance time of retroclavicular block will not exceed the performance time of its comparator.
This study is designed as a prospective randomized non-inferiority trial. Two groups of non-consecutive patients will be randomly assigned to either retroclavicular or coracoid infraclavicular block. This study will be carried out in three different centres simultaneously.
The multicentre trial will be conducted in two university hospitals (Centre hospitalier universitaire de Sherbrooke [CHUS] Hôtel-Dieu/Fleurimont and Centre Hospitalier de l'Université Laval [CHUL] in Quebec city) and a community hospital (Cowansville). The third participating establishment, Brome-Missisquoi-Perkins hospital, is located in Cowansville, a peripheral city of 15,000 people.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Elective or urgent surgery of the hand, wrist, forearm or elbow.
- •Age >18 years old.
- •ASA (American Society of Anesthesiologists) class 1, 2 and
- •Able to provide valid written consent.
- •Minimum body weight of 50 kg, despite BMI
排除标准
- •Patient refusal.
- •Previous surgery or gross anatomical deformity of the clavicle.
- •Systemic or local infection at needle entry point.
- •Coagulopathy.
- •Severe pulmonary condition.
- •Local anaesthetic allergy.
- •Pre-existing neurologic symptoms in the ipsilateral limb.
- •Pregnancy.
- •Surgical request of an indwelling catheter for post-operative analgesia
结局指标
主要结局
Time of block performance
时间窗: Measured directly during the procedure with a chronometer. Time of performance is composed of imaging time and needling time
The performance time corresponds to the sum of imaging time and needling time. It is expressed in minutes. Analysis of the primary outcome: performance time will be analyzed with a non-inferiority test of the averages, with the objective of finding that the experimental retroclavicular approach is no longer to perform than the coracoid infraclavicular approach. Subgroup analysis will be conducted to evaluate if higher body mass index influence (BMI) the outcomes, as the performance time, the needle visibility, the number of needle passes and the needle angle. Patient will be divided in two groups (higher and lower than the average BMI of all recruited patients) and analyzed according to their subgroup. If data is missing or if patient drop-out occurs, data will be analyzed with the intention-to-treat principle.
次要结局
- Imaging time(Measured directly during the procedure with a chronometer.)
- Number of needle passes(Number of needle passes required during procedure.)
- Needling time(Measured directly during the procedure with a chronometer.)
- Time to motor blockade evaluated at 10, 20 and 30 minutes after procedure(Blind assistant evaluates the loss of motor function in four muscular groups at 10, 20 and 30 minutes after the block.)
- Success of plexus block(Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed)
- Time to sensory loss evaluated at 10, 20 and 30 minutes after procedure(Blind assistant evaluates the loss of sensibility in 5 precise nerve territories, 10, 20 and 30 minutes after the block.)
- Early and late complications:(Assessed during each block and again at 48 hours after the block)
- Total anesthesia time(Intraoperative)
- Needle angle(Assessed one week after study completion)
- Neurostimulation use(Assessed during the block)
- Pain during the procedure(Patients will be asked to report the level of discomfort they felt during the procedure)
- Needle visualization(Assessed one week after study completion)
研究者
Pablo Echave
Anesthesiologist
Université de Sherbrooke