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 - Researchers who provide a methodologically sound proposal.
   


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


5. By what mechanism will data be made available?
   Response (Others) -  De-identified individual participant data will be stored in a secure institutional database (Department of Anaesthesiology & Critical Care, Command Hospital Air Force, Bengaluru). Researchers with a methodologically sound proposal can request access by submitting a written application to the Principal Investigator. The request will be reviewed and approved by the Institutional Ethics Committee (IEC). Upon approval, the data will be shared electronically via password-protected files or encrypted email transfer.


6. For how long will this data be available start date provided 19-03-2026 and end date provided 19-07-2029?
   Response - Beginning 3 months and ending 5 years following article publication.
   


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

This prospective, randomized clinical study will compare the efficacy of 0.25% Bupivacaine alone versus 0.25% Bupivacaine with 0.5 mcg/kg Dexmedetomidine in ultrasound-guided adductor canal block (ACB) for postoperative analgesia in unilateral total knee replacement (TKR) surgery. A total of 120 patients (ASA I–III, aged 40–85 years) undergoing elective unilateral TKR under spinal anaesthesia will be recruited and randomized into two groups (n=60 each).

Group B will receive 20 ml of 0.25% Bupivacaine, while Group D will receive 20 ml of 0.25% Bupivacaine with 0.5 mcg/kg Dexmedetomidine for ACB. Postoperative pain will be assessed using the Visual Analogue Scale (VAS) at 4, 8, 12, and 24 hours. Outcomes measured include:

• Duration of analgesia (time to first rescue analgesic)
• Total opioid (Tramadol) consumption in 24 hours
• Incidence of adverse effects (bradycardia, hypotension, sedation, nausea, vomiting, motor blockade, urinary retention)
• Patient satisfaction scores

Statistical analysis will involve t-test, Mann–Whitney U, repeated measures ANOVA, and Chi-square/Fisher’s exact test as appropriate, with p < 0.05 considered significant.

The study aims to determine whether the addition of Dexmedetomidine prolongs analgesia, reduces opioid requirement, and improves patient satisfaction without significant adverse effects, thereby contributing to enhanced recovery protocols after TKR.