Impact of Local Anesthetic Volume on Temperature Increase in the Upper Extremity During Ultrasound-guided Stellate Ganglion Block: A Prospective Randomized and Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Temperature change(°C) in ipsilateral arm
研究概览
简要总结
The purpose of this study was to compare the temperature changes of the upper extremities when using local anesthetic of various volume (4ml, 6ml, 8ml) in the ultrasound guided stellate ganglion block.
详细描述
One pain physician performs all US-guided stellate ganglion block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure.
For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 4ml, 6ml, and 8ml of 1% lidocaine is injected for the each group, respectively. Syringes are prepared by one nurse who do not involved in other steps of this study.
Temperature measurement is conducted 4 times (before US-guided SGB and after 10, 20, and 30m from SGB) at both hands, face, axillar by one person who's not involved in other measuring in the study.
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 (Participant)
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 aged 18 to 85 years
- •Patients with a new or known diagnosis of chronic neuropathic pain at the upper extremity or face.
排除标准
- •Refusal of a patient
- •Any vascular disease in the upper extremities (or face)
- •Previous history of thoracic sympathetic or stellate ganglion neurolysis (e.g. thermocoagulation, radiofrequency neuromodulation, and/or chemical neurolysis)
- •Coagulopathy
- •Systemic infection or local infection at the needle injection site
- •Major deformation at the level of the neck (radiotherapy, surgery, etc.)
- •Concomitant chronic pain syndrome at other sites.
- •Post-pneumonectomy on the controlateral side
- •Known allergy to local anesthetics of amide type
- •Inability to understand a numeric rating pain scale (cognitive dysfunction)
研究组 & 干预措施
4 ml of 1% lidocaine
Procedure: 4 ml of 1% lidocaine is injected for stellate ganglion block using the Ultrasound(US)-guided lateral approach at the sixth cervical vertebral level.
干预措施: Stellate ganglion block (Procedure)
6 ml of 1% lidocaine
Procedure: 6 ml of 1% lidocaine is injected for stellate ganglion block using the US-guided lateral approach at the sixth cervical vertebral level.
干预措施: Stellate ganglion block (Procedure)
8 ml of 1% lidocaine
Procedure: 8 ml of 1% lidocaine is injected for stellate ganglion block using the US-guided lateral approach at the sixth cervical vertebral level.
干预措施: Stellate ganglion block (Procedure)
结局指标
主要结局
Temperature change(°C) in ipsilateral arm
时间窗: thirty minute after US-guided SGB
Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger.
次要结局
- Temperature changes(°C) in ipsilateral arm(10 and 20 min after US-guided SGB)
- Temperature changes in ipsilateral face(10, 20, and 30 min after US-guided SGB)
- Temperature changes in contralateral face(10, 20, and 30 min after US-guided SGB)
- Temperature changes in ipsilateral medial elbow(10, 20, and 30 min after US-guided SGB)
- Temperature changes in contralateral medial elbow(10, 20, and 30 min after US-guided SGB)
- Severity of pain using an 11-pointed numerical rating scale(NRS) pain score(Time before block and time of block to 30 minutes after the block)
- Proportion of patients reaching >1.5°C rise of temperature in the ipsilateral arm compared to the contralateral arm(30 minutes after the block)
- Proportion of patients reaching >1.5°C rise of temperature in the ipsilateral face compared to the contralateral face(30 minutes after the block)
- Proportion of patients with ptosis(30 minutes after the block)
研究者
Jeeyoun Moon
Clinical Associate Professor
Seoul National University