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
   Response -  Analytic Code
   
   
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 - Proposals should be directed to [bijitbhakta@gmail.com].
   


6. For how long will this data be available start date provided 01-02-2024 and end date provided 31-01-2028?
   Response - Immediately following publication. No end date.
   


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

1. Proposed research details:

a) Name of candidate: Dr. Bijit Bhakta, Post Graduate Trainee, Department of Anaesthesiology, College of Medicine &Sagore Dutta, Kolkata.

b) Place of proposed research work: Orthopedics OT at OT complex, College of Medicine & Sagore Dutta, Kolkata.

c) Broad area: Anaesthesiology

d) Specific area: Analgesic duration and haemodynamics in upper limb surgery

2. Proposed supervisor:

Dr. Anjan Das, Associate Professor, Department of Anaesthesiology, College of Medicine & Sagore Dutta, Kolkata.

3. Proposed topic of the research:

A DOUBLE BLIND RANDOMIZED CONTROLLED STUDY FOR EVALUATING THE ROLE OF DEXMEDETOMIDINE AS ADJUVANT TO 0.5% ROPIVACAINE IN AXILLARY PLEXUS BLOCK FOR PATIENT UNDERGOING FOREARM AND HAND SURGERY.

4. Objective of the proposed research:

The present study is aimed to compare the analgesic duration and haemodynamic effects after administration of axillary plexus block by 0.5% Ropivacaine with Dexmedetomidine as adjuvant vs Normal Saline as control.

5. Background of the present study:

Different adjuvants have been used to prolong the duration of analgesia like Fentanyl, Clonidine, Dexamethasone and Morphine. In recent times Dexmedetomidine as been emerged as a promising adjuvant in different regional blocks. We will evaluate the effect of adding dexmedetomidine to 0.5% ropivacaine for axillary plexus blockade in comparison with normal saline as control.The primary endpoints will be duration of sensory block (duration of analgesia).

6. Methodology:

A total of 84 patients (20-50 years) posted for elective forearm and hand surgery under axillary block were divided into two equal groups (Group R and RD) in a randomized, double-blind fashion. In group RD (n =42) 30 ml 0.5% ropivacaine +1 ml (100 μg) of dexmedetomidine and group R (n = 42) 30 ml 0.5% ropivacaine +1 ml normal saline were administered in axillary block. Sensory and motor block onset times and the block duration time to first analgesic use, total analgesic need, postoperative VAS (visual analog scale) score, hemodynamics and side-effects were recorded for each patient. The amount of motor block was assessed by Modified Bromage Scale.

MODIFIED BROMAGE SCALE

     Grade                              Definition

     4                                  Full muscle strength in relevant muscle group

     3                                  Reduced strengths, but able to move against resistance

     2                                  Ability to move against gravity, but not against resistance

     1                                  Discrete movements of muscle (trembling) groups

     0                                  Lack of movement

7. Expected Outcome:

The use of dexmedetomidine as an adjuvant to 0.5% Ropivacaine should provide longer duration of analgesia than 0.5% Ropivacaine with normal saline as control. Both the drugs are haemodynamically stable but significant bradycardia is seen with dexmedetomidine. In the outcome of my proposed study, it will be determined whether there is any significant difference in prolonging the duration of analgesia and reducing postoperative pain.