1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [drramyashre2012@gmail.com].
   


6. For how long will this data be available start date provided 26-07-2023 and end date provided 26-07-2026?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Regional Anaesthesia is the preferred technique during Lower Segment Cesarean Section. Bupivacaine is the most commonly used local anaesthetic agent in spinal anaesthesia. Opioids such as fentanyl are commonly used as intrathecal adjuvants to improve the quality of intraoperative analgesia and prolonged post-operative analgesia. 

The rapid onset of sympathetic blockade and subsequent hypotension remains a major clinical concern. Hypotension leads to nausea, vomiting and neonatal morbidity by reducing uteroplacental blood flow. Lowering the dose of intrathecal bupivacaine by using fentanyl as adjuvant can be used to maintain better hemodynamic stability, lesser requirement of vasopressors, provide better analgesia, reduced Post-Operative Nausea and Vomiting.

This study is undertaken to study the effect of Hyperbaric Bupivacaine 0.5% 5mg with fentanyl 10mcg vs of Hyperbaric Bupivacaine 0.5% 5mg with fentanyl 20mcg in spinal anaesthesia on hemodynamic changes, onset, level, duration and speed of regression of Sensory and Motor blockade in Parturients undergoing Lower Segment Caesarean Section.

Our study is Randomised Controlled study which will be conducted in Bangalore Medical College And Research Institute, Bangalore. It will be conducted on 100 participants, 50 in Hyperbaric Bupivacaine 0.5% 5mg with fentanyl 10mcg group and 50 in Hyperbaric Bupivacaine 0.5% 5mg with fentanyl 20mcg.

Intraoperatively Hemodynamic variables and level and depth of anaesthesia will be recorded every minute for first five minutes, at 5 minutes for next half an hour after the administration of subarachnoid block and every 10 minutes thereafter up to 120 minutes after the block. Postoperatively patient will be monitored every 1hr for the first 4hours. Side effects such as hypotension, bradycardia, shivering, nausea, vomiting, pruritis, respiratory depression and ECG changes will be recorded and accordingly managed.