BACKGROUND Peripheral nerve block is preferable for lower extremity surgery because it sufficiently blocks pain pathways at different levels providing excellent anaesthesia at the site of surgery. We designed this study to compare the efficacy and safety of SOFT block (sciatic-obturator-femoral technique) compared with spinal anaesthesia in patients undergoing surgery for fixation of open tibial fractures using Ilizarov external fixator. METHODS One hundred and seven patients ASA I, II scheduled for fixation of open tibial fractures using Ilizarov external fixator. The patients were randomly allocated to receive either spinal anaesthesia or SOFT block. In spinal anaesthesia group, patients received spinal anaesthesia with hyperbaric bupivacaine 0.5% (7. 5-10mg). In SOFT group, patients received SOFT block with bupivacaine 0.25%. Primary endpoint included the duration of analgesia. The secondary endpoints included patient satisfaction scores, visual analogue scores, incidence of adverse events as vomiting, systemic toxicity from local anaesthetic drug and time to first effect of the techniques. RESULTS The duration of SOFT block and time to first analgesic dose in SOFT group was significantly longer (p < 0.001). There was no significant difference between the study groups regarding satisfaction scores, the incidence of cardiovascular collapse, seizures and paraesthesia. Pain scores were significantly lower in SOFT group at 3,6,12 h postoperative (p < 0.001). The time to the first effect was significantly longer in SOFT group (p < 0.001). CONCLUSION SOFT is a feasible technique of local anaesthesia for control of postoperative pain with unremarkable adverse events compared with spinal anaesthesia, in patients undergoing fixation of tibial fractures using Ilizarov external fixator. TRIAL REGISTRATION This trial was retrospectively registered at ClinicalTrials.gov. registry number: NCT03450798 on February 20, 2018.

中文翻译：

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使用Ilizarov外固定器对接受开放性胫骨骨折手术的患者进行坐骨神经闭孔股动脉技术与脊柱麻醉。一项随机试验。

背景技术外周神经阻滞对于下肢手术是优选的，因为它充分阻塞了不同水平的疼痛途径，从而在手术部位提供了出色的麻醉效果。我们设计了本研究，以比较在使用Ilizarov外固定器进行胫骨开放性骨折固定手术的患者中，将SOFT阻滞（坐骨神经闭塞性股骨技术）与脊柱麻醉的安全性进行比较。方法107例ASA I，II型患者计划使用Ilizarov外固定架固定胫骨开放性骨折。随机分配患者接受脊髓麻醉或SOFT阻滞。在脊柱麻醉组，患者接受0.5％布比卡因高压麻醉（7​​. 5-10mg）进行脊柱麻醉。在SOFT组中，患者接受0.25％布比卡因的SOFT阻滞剂。主要终点包括镇痛时间。次要终点包括患者满意度评分，视觉模拟评分，呕吐不良事件的发生率，局部麻醉药引起的全身毒性以及首次使用该技术的时间。结果SOFT组的SOFT阻滞持续时间和首次镇痛剂量的时间明显更长（p <0.001）。研究组之间在满意度评分，心血管衰竭，癫痫发作和感觉异常的发生率方面无显着差异。SOFT组术后3、6、12 h的疼痛评分显着降低（p <0.001）。在SOFT组中，达到第一个效果的时间明显更长（p <0.001）。结论对于使用Ilizarov外固定器固定胫骨骨折的患者，与脊柱麻醉相比，SOFT是一种可行的局部麻醉技术，可控制术后疼痛，且不良反应不明显。试验注册该试验是在ClinicalTrials.gov上进行的回顾性注册。注册表号：NCT03450798,2018年2月20日。