The Efficacy of Extra- Versus Intrafascial Injection for Supraclavicular Brachial Plexus Block: a Randomized Controlled, Single-blinded Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Hemidiaphragmatic paresis 30 minutes after the block
研究概览
简要总结
Patients will be randomized to one of two groups:
- Extrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the exterior of the fascial sheath that surrounds the nerves
- Intrafascial injection group: Ultrasound-guided supraclavicular brachial plexus block with 2 injections of local anaesthetic, deposited at the interior of the fascial sheath that surrounds the nerves
详细描述
The study will be proposed to all patients undergoing formarm or hand surgery under axillary brachial plexus block. Patients will be randomized to one of two groups.
The first group - extrafascial injection group - will receive an ultrasound-guided supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the exterior of the fascial sheath that surrounds the nerves.
The second group - intrafascial injection group - will receive an ultrasound-guided supraclavicular brachial plexus block whereby the local anesthetic will be deposited at the interior of the fascial sheath that surrounds the nerves.
All patients will receive the same type and amount of local anesthetic: 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %.
The primary outcome is the rate of hemidiaphragmatic paresis 30 minutes after the block procedure, assessed with ultrasound. Secondary outcomes are: rate of hemidiaphragmatic paresis 2 hours after surgery, assessed with ultrasound, bedside spirometry before the supraclavicular block, 30 minutes after the block and 2 hours after surgery, rate of successful block 30 minutes after the block , duration of sensory and motor block, pain scores at rest and on movement at 24 h postoperatively, cumulative postoperative opioid consumption at 24 hours postoperatively and patient satisfaction with overall anesthetic management.
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, Care Provider)
盲法说明
The participants and all care providers will be blinded to the patient assignment.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing forearm or hand surgery under locoregional anesthesia
- •ASA physical status I-III
排除标准
- •Patient refusal
- •ASA physical status IV
- •Severe pre-existing lung disease
- •Patient unwilling or unable to perform incentive spirometry
- •Local anesthetic intolerance or allergy
- •Neurological deficit or neuropathy of the arm
- •Coagulopathy contraindicating locoregional anesthesia
- •Malignancy or infection in the area above the clavicle
- •Pregnancy
- •Inability to understand the informed consent
结局指标
主要结局
Hemidiaphragmatic paresis 30 minutes after the block
时间窗: 30 minutes after the block
Rate of hemidiaphragmatic paresis 30 minutes after the block procedure, assessed with ultrasound
次要结局
- Block-related side effects(24 h postoperatively)
- Bedside spirometry before the block (baseline)(30 minutes before the block)
- Pain during block procedure(During block procedure)
- Hemidiaphragmatic paresis 2 hours after surgery(2 hours after surgery)
- Postoperative opioid consumption(24 hours postoperatively)
- Bedside spirometry 2 hours after surgery(2 hours after surgery)
- Rate of successful block 30 minutes after the block(30 minutes after the block)
- Patient satisfaction with overall anesthetic management(24 hours postoperatively)
- Bedside spirometry after 30 minutes after the block(30 minutes after the supraclavicular block)
- Pain at rest and on movement(24 h postoperatively)