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CTRI Number  CTRI/2024/03/063571 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 04/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative study between dexmedetomidne and magnesium sulphate when added with ropivacaine for brachial plexus block in hand surgeries 
Scientific Title of Study   ULTRASOUND GUIDED AXILLARY APPROACH TO BRACHIAL PLEXUS FOR HAND SURGRIES COMPARISION OF MAGNESIUM SULPHATE AND DEXMEDETOMIDINE AS ADJUVANTS TO ROPIVACAINE 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nagella Jagadeesh Babu 
Designation  Associate professor 
Affiliation  Government Medical College Kadapa 
Address  Department of anaesthesiology second floor, ip building government medical college Cuddapah Andhra pradesh 516002 India

Cuddapah
ANDHRA PRADESH
516002
India 
Phone  9949706329  
Fax    
Email  mansoormohammed473@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nagella Jagadeesh Babu 
Designation  Associate professor 
Affiliation  Government Medical College Kadapa 
Address  Department of anaesthesiology second floor, ip building government medical college Cuddapah Andhra pradesh 516002 India


ANDHRA PRADESH
516002
India 
Phone  9949706329  
Fax    
Email  mansoormohammed473@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nagella Jagadeesh Babu 
Designation  Associate professor 
Affiliation  Government Medical College Kadapa 
Address  Department of anaesthesiology second floor, ip building government medical college Cuddapah Andhra pradesh 516002 India


ANDHRA PRADESH
516002
India 
Phone  9949706329  
Fax    
Email  mansoormohammed473@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology government medical college kadapa  
 
Primary Sponsor  
Name  Dr Sunil Chiruvella 
Address  Department of anesthesiology Government medical college kadapa 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nagella Jagadeesh Babu  Government General Hospital  Department of anaesthesiology 2nd floor ip building
Cuddapah
ANDHRA PRADESH 		 9949706329

mansoormohammed473@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government Medical College, KADAPA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: W01||Fall on same level from slipping,tripping and stumbling, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dexmedetomidine 30 mcg  Adding of 30 mcg dexmedetomidine to 0.5% ropivacaine for axillary brachial plexus block for hand surgeries, for upto 12 hrs 
Comparator Agent  magnesium sulphate 100mg  adding of 100 mg magnesium sulphate to 0.5% ropivacaine for axillary brachial plexus block for hand surgeries 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients undergoing hand surgeries
ASA 1 & 2 
 
ExclusionCriteria 
Details  Patients with Co-existing severe cardiovascular respiratory or neurological disorders
Patients with any known history of coagulation disorders and inflammatory and infective skin lesions at the site of block
Pre-existing neuropathies and allergy to local anaesthetics 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary objective is to compare onset and
duration of sensory and motor blockade 		 5 mins
10 mins
15 mins
30 mins
1 hour
2 hours
6 hours
12 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objective is to compare hemodynamic changes, Time for requirement of rescue analgesia and adverse effects in both groups  5 mins
10 mins
15 mins
30 mins
1 hour
2 hours
6 hours
12 hours 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   11/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Axillary brachial plexus blocks are frequently used during hand and forearm procedures. Ropivacaine’s effectiveness is increased when Dexmedetomidine and magnesium sulphate are used for peripheral nerve blocks because they increase the duration of analgesia. This study was aimed to evaluate the effects of. Ropivacaine with magnesium sulphate and Ropivacaine with Dexmedetomidine in the axillary block.Site-specific, efficient, and long-lasting anaesthetic is provided via regional anaesthesia. To enable painless surgery, plexus block is employed as the primary anaesthetic approach. It is also utilised to alleviate chronic pain and post-operative discomfort.Regional anaesthesia is administered during procedures on the upper limbs using a brachial plexus block. Interscalene, supraclavicular, infraclavicular, and axillary are some other techniques. The axillary method to the brachial plexus block is well-liked for its simplicity, dependability, and safety. It is recommended for forearm and hand surgery.With a safer cardiac profile than bupivacaine, ropivacaine is a brand-new long-acting amide local anaesthetic (LA) used for peripheral nerve blocks. It offers both a sensory and a motor blockage. Adjuvant supplementation increases the effectiveness of LA by accelerating the start of action, extending the duration of activity, and providing postoperative analgesia.When administered systemically, magnesium sulphate (MgSO4) has analgesic, antihypertensive, and anaesthetic sparing effects. MgSO4 is now often utilised as an adjuvant to plane blocks, other peripheral nerve blocks, and neuroaxial blocks. However, research on MgSO4’s use as an adjuvant in the axillary block is quite limited.As an adjuvant to LAs, dexmedetomidine is a selective alpha 2 adrenoreceptor agonist. It is believed to shorten the onset and increase the duration of activity, and prolong postoperative analgesia. 
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