Department of Anaesthesia, General Intensive Care Medicine and Pain Therapy, Medical University of Vienna, Vienna, Austria.
Department of Anesthesiology, Clinica Ars Medica, Genolier Swiss Medical Network, Gravesano, Switzerland.
Sci Rep. 2021 May 11;11(1):10035. doi: 10.1038/s41598-021-89483-y.
Chloroprocaine is a short-acting local anaesthetic with a rapid onset of action and an anaesthesia duration up to 60 min. In this pivotal study success rates, onset and remission of motor and sensory block and safety of chloroprocaine 2% was compared to ropivacaine 0.75% for short-duration distal upper limb surgery with successful block rates as primary outcome. The study was designed as a prospective, randomised, multi-centre, active-controlled, double-blind, parallel-group, non-inferiority study, performed in 4 European hospitals with 211 patients scheduled for short duration distal upper limb surgery under axillary plexus block anaesthesia. Patients received either ultrasound guided axillary block with 20 ml chloroprocaine 2%, or with 20 ml ropivacaine 0.75%. Successful block was defined as block without any supplementation in the first 45 min calculated from the time of readiness for surgery. 90.8% patients achieved a successful block with chloroprocaine 2% and 92.9% patients with Ropivacaine 0.75%, thus non-inferiority was demonstrated (10% non inferiority margin; 95% CI - 0.097, 0.039; p = 0.02). Time to onset of block was not significantly different between the groups. Median time to motor and sensory block regression was significantly shorter as was time to home discharge (164 [155-170] min for chloroprocaine versus 380 [209-450] for the ropivacaine group, p < 0.001). For short-duration surgical procedures, the short-acting Chloroprocaine 2% may be used, with success rates non-inferior to ropivacaine and a favourable safety profile.Trial registration: The trial was registered at Clinicaltrials.gov with registration number NCT02385097 (March 11th, 2015) and European Clinical Trial Database with the EudraCT number 2014-002519-40 (July 7th, 2015, Austria-BASG).
氯普鲁卡因是一种起效迅速、麻醉持续时间长达 60 分钟的短效局部麻醉剂。在这项关键性研究中，氯普鲁卡因 2%的起效时间、运动和感觉阻滞的消退以及安全性与罗哌卡因 0.75%在用于持续时间短的上肢远端手术进行了比较，以阻滞成功率作为主要结局。该研究是一项前瞻性、随机、多中心、主动对照、双盲、平行组、非劣效性研究，在欧洲的 4 家医院进行，共有 211 名患者在腋路神经阻滞麻醉下接受持续时间短的上肢远端手术。患者接受的是超声引导下的腋路阻滞，分别使用 20ml 氯普鲁卡因 2%或 20ml 罗哌卡因 0.75%。成功阻滞定义为从准备手术开始计算的 45 分钟内无需任何补充的阻滞。氯普鲁卡因 2%组有 90.8%的患者达到成功阻滞，罗哌卡因 0.75%组有 92.9%的患者达到成功阻滞，因此证实了非劣效性（10%非劣效性边界；95%CI-0.097，0.039；p=0.02）。两组间阻滞起效时间无显著差异。运动和感觉阻滞消退的中位时间以及出院回家的时间显著缩短（氯普鲁卡因组为 164[155-170]分钟，罗哌卡因组为 380[209-450]分钟，p<0.001）。对于持续时间短的手术，可使用起效迅速的氯普鲁卡因 2%，其成功率不劣于罗哌卡因，且安全性良好。
该试验于 2015 年 3 月 11 日在 Clinicaltrials.gov 上注册，注册号为 NCT02385097，并于 2015 年 7 月 7 日在欧洲临床试验数据库上注册，注册号为 EudraCT 2014-002519-40（奥地利 BASG）。
