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CTRI Number  CTRI/2025/09/094345 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 06/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To compare two methods of giving magnesium sulfate with ropivacaine to improve pain relief in upper limb surgery. 
Scientific Title of Study   Efficacy of Intravenous versus Perineural Magnesium Sulfate as an adjunct to Ropivacaine in Axillary Plexus Block: A Randomized Controlled Double Blind Trial. 
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 Reetu Arora  
Designation  Post Graduate Trainee 1 (M.D. Anaesthesiology) 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, Kalinga Institute Of Medical Sciences, Third floor, Bhubaneswar, Odisha.

Khordha
ORISSA
751024
India 
Phone  8105182702  
Fax    
Email  ritu.arora65@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Maj Pramod Patra  
Designation  Professor (Anaesthesiology) 
Affiliation  Kalinga Institute of Medical Sciences  
Address  Department of Anaesthesiology, Kalinga Institute Of Medical Sciences, Third floor, Bhubaneswar, Odisha.

Khordha
ORISSA
751024
India 
Phone  7008466151  
Fax    
Email  pramod.patra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Laxman Kumar Senapati  
Designation  Associate Professor (Anaesthesiology) 
Affiliation  Kalinga Institute of Medical Sciences  
Address  Department of Anaesthesiology, Kalinga Institute Of Medical Sciences, Third floor, Bhubaneswar, Odisha.

Khordha
ORISSA
751024
India 
Phone  7325919471  
Fax    
Email  meet.laxmans1@gmail.com  
 
Source of Monetary or Material Support  
Kalinga Institute Of Medical Sciences Bhubaneswar, Odisha. Khordha Orissa 751024 India 
 
Primary Sponsor  
Name  Dr. Reetu Arora 
Address  Department of Anaesthesiology, Third floor, Kalinga Institute Of Medical Sciences, Bhubaneswar, Odisha, PIN: 751024 
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 Reetu Arora  Kalinga Institute Of Medical Sciences   Department Of Anaesthesiology, 3rd floor OT Complex, KIMS and Pradyumna Bal Memorial Hospital, KIIT Deemed to be University, Patia, Bhubaneswar Khordha Orissa
Khordha
ORISSA 		 8105182702

ritu.arora65@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE KALINGA INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.5% Ropivacaine with intravenous magnesium sulfate   Group I - Patients will receive 150mg magnesium sulfate diluted in 100ml of normal saline, administered intravenously over 30 minutes before the block. Subsequently, 15ml of 0.5% ropivacaine mixed with 2ml of normal saline will be administered perineurally via the axillary brachial plexus block. Route: Intravenous  
Comparator Agent  0.5% Ropivacaine with normal saline  Group III - Patients will receive 100ml of normal saline intravenously over 30minutes before the block. Subsequently, 15ml of 0.5% ropivacaine mixed with 2ml of normal saline will be administered perineurally via the axillary brachial plexus block. Route: Perineural  
Intervention  0.5% Ropivacaine with perineurial magnesium sulfate   Group II - Patients will receive 100ml of normal saline intravenously over 30 minutes before the block. Subsequently, 15ml of 0.5% ropivacaine mixed with 2ml containing 150mg magnesium sulfate will be administered perineurally via the axillary brachial plexus block. Route: Perineural 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. American Society of Anaesthesiologists physical status (ASA) I-III.
2. Patients undergoing forearm and hand surgeries.  
 
ExclusionCriteria 
Details  1. Patients with allergy to Ropivacaine and Magnesium sulfate.
2. Coagulopathy or local infection at the injection site.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Sensory blockade duration  Assessed from time of completion of block until complete return of sensation, recorded in minutes. 
 
Secondary Outcome  
Outcome  TimePoints 
Sensory blockade onset  Onset time of sensory blockade in minutes. 
Motor blockade onset   Onset time of motor blockade in minutes. 
Motor blockade duration   Duration of motor blockade in minutes. 
Post operative analgesia duration  Total duration of post operative analgesia in hours. 
Total opioid consumption in mg  24 hours. 
Post operative VAS score   0, 3, 6, 9, 12 and 24 hours. 
Patient satisfaction with Likert scale  24hours postoperatively.  
 
Target Sample Size   Total Sample Size="123"
Sample Size from India="123" 
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   N/A 
Date of First Enrollment (India)   17/09/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   In axillary brachial plexus block, located anaesthetic agents provide reliable anaesthesia and analgesia for forearm and hand surgeries. The effect of the block can be prolonged and improved with the use of various adjuvants. Magnesium sulfate with both perineural and intravenous routes showing potential benefit, has not been compared directly in this setting. This study will evaluate whether intravenous or perineural magnesium sulfate, when used as an adjuvant to 0.5% ropivacaine increases the duration and quality of block and improves post operative analgesia and patient satisfaction.  
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