1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Data are available indefinitely at (Link to be included pritimourya9646@gmail.com).
   


6. For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2036?
   Response - Immediately following publication. No end date.
   


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

Labour pain is one of the most painful experience for a woman. Evidence is suggestive that disorders including maternal hypertension, dystocia, meconium staining, and foetal distress are stress related.

Of all the available methods of analgesia, epidural analgesia satisfies the basic requirements of analgesia by fulfilling the objective of decreasing the pains without affecting other sensations such as a desire to push and to allow normal walking while preserving the tone of pelvic floor muscles. This EA technique has been commonly named as “walking epidural”.

 Ropivacaine, a well-established local anaesthetic agent, has gained recognition for its favourable safety profile, particularly in comparison to its counterpart, bupivacaine. Its use in epidural analgesia, either as a standalone agent or in combination with adjuvants like fentanyl, has become a standard practice in obstetric anaesthesia.

There are only few studies comparing between 0.125% ropivacaine and 0.2% ropivacaine for labour pain management. We hypothesise that 0.125% ropivacaine is equally effective analgesic as 0.2% ropivacaine for labour pain with less of motor block and other associated side effects. This study will be conducted over a period of 18 months after the approval of Institutional Ethics Committee, with calculated sample size of 32 in total. With due inclusion and exclusion criteria set. Patients will be divided in two groups by computer generated double blinded block randomization technique.

 GROUP A: This group will receive the 12 ml ⁽⁷⁾of Ropivacaine 0.125% with 2μg/ml fentanyl. GROUP B: This group will receive 12 ml of Ropivacaine 0.2% with 2 μg/ml fentanyl.

Pain scores (VAS), sensory and motor block characteristics, and vital parameters (pulse, mean arterial pressure, respiratory rate) will be documented at 0 (before epidural), 5, 15 minutes, and then every 10 minutes until 1 hour, followed by assessments every 60 minutes until delivery. Throughout the study, fetal heart rate will be continuously monitored using a cardiotocograph (CTG). Further assessment will include evaluating the Apgar score at 1 and 5 minutes.

This study informs personalized pain management, enhances safety and maternal satisfaction, and influences healthcare policy. It advances evidence-based obstetric anaesthesia practices, contributing to a more patient-centered approach in, potentially improving the childbirth experience for mothers, and informing future research and clinical guidelines