Kulkarni Sadhana Sudhir, Tayade Deepak Narayan, Parchandekar Mukund Kachru, Nayak Prabha Pandurang, Kelkar Vasanti Prabhakar, Pachore Prashant Jangonda
Department of Emergency Medicine, MGM Medical College and Hospital, Aurangabad, Maharashtra, India.
Department of Community Medicine, MGM Medical College and Hospital, Aurangabad, Maharashtra, India.
Indian J Anaesth. 2021 Sep;65(9):684-694. doi: 10.4103/ija.ija_639_21. Epub 2021 Oct 8.
Incidence of major neurological complications following central neuraxial blockade (CNB) in India is not known. This information is essential for explaining risk preoperatively to patients and for medico-legal purposes. This study was undertaken to assess feasibility (recruitment process, protocol adherence, resources mobilisation, data management and evaluation of scientific outcome) for planning multicentric studies on major neurological complications following CNB at state/national level.
This was a hospital-based, multicentre pilot study, with cross-sectional and follow-up components. Patients receiving CNB either perioperatively or during acute/chronic pain management were included in the study. Thirty-six randomly selected tertiary and nontertiary care institutes were included. Details of demographic information, CNB procedure and major neurological complications were collected anonymously via online tools. Feedback about study feasibility was collected from participating anaesthesiologists and study team.
Selected institutes continued participation throughout study period. About 99.98% of eligible patients were enroled. Complete data collection of 8053 patients and analysis was possible. Regular reminders from study coordinators helped to optimise data collection. Tertiary care institutes contributed to 74.50% of data. About 64.96% patients were females. Spinal anaesthesia was the most frequently used neuraxial block (93.41%). Bupivacaine and adjuvant were used in 95.53% and 16.5% patients, respectively. Two patients developed cardiac arrest and cause-effect relationship with CNB was established. Participants' recruitment, protocol adherence, resources mobilisation, data management and evaluation of scientific outcomes were feasible.
A multicentre state/nationwide study can be conducted based on this first-of-its-kind pilot study in India.
在印度，中枢神经阻滞（CNB）后严重神经并发症的发生率尚不清楚。这些信息对于术前向患者解释风险以及用于医疗法律目的至关重要。本研究旨在评估在州/国家层面开展关于CNB后严重神经并发症的多中心研究的可行性（招募过程、方案依从性、资源调动、数据管理和科学结果评估）。
这是一项基于医院的多中心试点研究，包括横断面研究和随访部分。纳入围手术期或急性/慢性疼痛管理期间接受CNB的患者。纳入了36家随机选择的三级和非三级医疗机构。通过在线工具匿名收集人口统计学信息、CNB操作和严重神经并发症的详细信息。从参与的麻醉医生和研究团队收集关于研究可行性的反馈。
选定的机构在整个研究期间持续参与。约99.98%的符合条件患者被纳入。对8053例患者进行完整的数据收集和分析是可行的。研究协调员的定期提醒有助于优化数据收集。三级医疗机构贡献了74.50%的数据。约64.96%的患者为女性。脊髓麻醉是最常用的神经阻滞方式（93.41%）。分别有95.53%和16.5%的患者使用了布比卡因和佐剂。两名患者发生心脏骤停，并确定了与CNB的因果关系。参与者的招募、方案依从性、资源调动、数据管理和科学结果评估是可行的。
基于印度同类首次试点研究，可以开展一项多中心的州/全国性研究。
