Major neurological complications following central neuraxial blockade - A multicentre pilot study in Aurangabad city (MGMA CNB Study).

BACKGROUND AND AIMS: 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.

METHODS

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.

RESULTS

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.

CONCLUSION

A multicentre state/nationwide study can be conducted based on this first-of-its-kind pilot study in India.