The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Paravertebral Block in Patients With Chronic Upper Extremity Neuropathic Pain: 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
- 69
- 试验地点
- 2
- 主要终点
- Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand
研究概览
简要总结
The purpose of this study is to investigate the effect of ultrasound-guided thoracic paravertebral block (TPVB) when performing sympathetic block for upper limb pain control.
详细描述
Well-trained pain physicians performs all US-guided stellate ganglion block(SGB)s or US-guided thoracic paravertebrl block(TPVB)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. 5 ml of 1% mepivacaine is injected for the SGB group. Syringes are prepared by one nurse who do not involved in other steps of this study.
For US-guided TPVB, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at T2 paravertebral space. 10 ml of 1% mepivacaine is injected for the TPVB group. Syringes are prepared by one nurse who do not involved in other steps of this study.
Temperature measurement is conducted 2 times (before US-guided SGB or TPVB and after 20 minutes) at both hands 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
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of complex regional pain syndrome
- •Clinical diagnosis of postherpetic neuralgia
- •Clinical diagnosis of phantom limb pain
- •Clinical diagnosis of chronic post-surgical pain
- •Clinical diagnosis of post-traumatic pain syndrome
- •Upper extremity pain lasting more than 3 months
- •Patients with a new or known diagnosis of chronic neuropathic pain lasting more than 3 months in the upper extremity
排除标准
- •Refusal of a patient
- •Any vascular disease in the upper extremities
- •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.)
- •Known allergy to local anesthetics of amide type
- •Inability to understand a numeric rating pain scale (cognitive dysfunction)
- •Patients whose palm temperature on the ipsilateral side is ≥ 36.5℃ in the thermography before the procedure
结局指标
主要结局
Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand
时间窗: 20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger.
次要结局
- Blood flow velocity measurement in upper extremity vessel(ipsilateral brachial artery) using ultrasound(Time before block and 20minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block)
- Difference of temperature change (°C) between ipsilateral hand and contralateral hand(20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block)
- Severity of pain(Time before block and 20 minutes and 1 week and 4weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block)
- Patient global impression change (PGIC)(Time 20 minutes and 1 week and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block)
- Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire(Time before block and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block)
研究者
Jeeyoun Moon
Associate Professor
Seoul National University