Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai, 200233, China.
Trials. 2020 Feb 19;21(1):204. doi: 10.1186/s13063-020-4078-9.
The innervation of the shoulder-upper-extremity area is complicated and unclear. Regional anesthesia with a brachial plexus and cervical plexus block is probably inadequate for the proximal humeral surgery. Missing blockade of the T1-T2 nerves may be the reason. We conduct this prospective randomized controlled trial (RCT) to explore whether an additional T2 thoracic paravertebral block (TPVB) can improve the success rate of regional anesthesia for elderly patients in proximal humeral fracture surgery.
METHODS/DESIGN: The patients aged 65 years or older, referred for anterior-approach proximal humeral fracture surgery, will be enrolled. Each patient will be randomly assigned 1:1 to receive a combined interscalene brachial plexus with superficial cervical plexus block (IC) (combined interscalene brachial plexus with superficial cervical plexus block) or an IC block combined with thoracic paravertebral block (ICTP) block (combined thoracic paravertebral block with brachial plexus and superficial cervical plexus block). The primary outcome is the success rate of regional anesthesia without rescue analgesic methods. The secondary outcomes are as follows: sensory block at the surgical area, proportion of patients who need rescue anesthesia (intravenously administered remifentanil or conversion to general anesthesia), cumulative doses of intraoperative vasoactive medications and adverse events. The total sample size is estimated to be 80 patients.
This RCT aims to confirm whether an additional T2 TPVB can provide better anesthetic effects of regional anesthesia with brachial and cervical plexus block in elderly patients undergoing proximal humeral surgery.
ClinicalTrials.gov, ID: NCT03919422. Registered on 19 April 2019.
肩部和上肢区域的神经支配复杂且不明确。臂丛和颈丛阻滞的区域麻醉可能不足以满足肱骨近端手术的需要。可能的原因是 T1-T2 神经阻滞不完全。我们进行这项前瞻性随机对照试验（RCT），以探讨 T2 胸椎旁神经阻滞（TPVB）是否可以提高老年肱骨近端骨折手术患者区域麻醉的成功率。
方法/设计：将纳入年龄在 65 岁及以上、拟行前路肱骨近端骨折手术的患者。每位患者将按 1:1 随机分配接受联合肌间沟臂丛加颈浅丛阻滞（IC）（联合肌间沟臂丛加颈浅丛阻滞）或 IC 阻滞联合胸椎旁阻滞（ICTP）（联合胸椎旁阻滞加臂丛和颈浅丛阻滞）。主要结局是无抢救性镇痛方法的区域麻醉成功率。次要结局包括：手术区域的感觉阻滞、需要抢救性麻醉的患者比例（静脉注射瑞芬太尼或转为全身麻醉）、术中血管活性药物的累积剂量和不良事件。总样本量估计为 80 例。
这项 RCT 旨在证实 T2 胸椎旁神经阻滞是否可以为老年肱骨近端手术患者提供更好的臂丛和颈丛阻滞的区域麻醉效果。
ClinicalTrials.gov，ID：NCT03919422。于 2019 年 4 月 19 日注册。
