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CTRI Number  CTRI/2025/01/079680 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 26/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study comparing magnesium sulphate(chemical) and dexamethasone(steroid) with levobupivacaine(local anesthetic) in infraclavicular(below neck)nerve block(anesthesia technique) for pain control in patients undergoing below elbow surgeries using ultrasound(non invasive imaging) 
Scientific Title of Study   Effectiveness of Ultrasound guided Infraclavicular block with 0.5%levobupivacaine with Magnesium Sulfate vs 0.5%levobupivacaine with Dexamethasone in below Elbow orthopedic surgeries-A Randomised Double Blinded study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gnana Mounica Nadimpalli 
Designation  Post graduate student 
Affiliation  IMS and SUM hospital 
Address  Department of Anesthesiology, IMS and SUM hospital, Siksha O Anusandhan University, khordha, Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  9494575619  
Fax    
Email  gnanamounica08@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhusmita Patro 
Designation  Associate Professor 
Affiliation  IMS and SUM hospital 
Address  Department of Anesthesiology IMS and SUM hospital Siksha O Anusandhan University Bhubaneswar Khordha 751003 Orissa India

Khordha
ORISSA
751003
India 
Phone  07746063128  
Fax    
Email  dr.madhu.patro@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Madhusmita Patro 
Designation  Associate Professor 
Affiliation  IMS and SUM hospital 
Address  Department of Anesthesiology IMS and SUM hospital Siksha O Anusandhan University Bhubaneswar Khordha 751003 Orissa India


ORISSA
751003
India 
Phone  07746063128  
Fax    
Email  dr.madhu.patro@gmail.com  
 
Source of Monetary or Material Support  
IMS and SUM hospital, Siksha O Anusandhan University, Bhubaneswar,Khordha,751003 
 
Primary Sponsor  
Name  Institute of Medical Science and Sum Hospital 
Address  K8 Kalinga Nagar Bhubaneswar Orissa 751003 
Type of Sponsor  Private medical college 
 
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 Gnana Mounica Nadimpalli  Institute of Medical Science, Siksha O Anusandhan  Department of Anesthesiology IMS and SUM hospital Siksha O Anusandhan University Bhubaneswar Khordha 751003 Orissa India
Khordha
ORISSA 
09494575619

gnanamounica08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, IMS and SUM Hospital, Bhubaneswar  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 
Comparator Agent  Dexamethasone  Patients will be receiving 2ml (8mg) Dexamethasone with 20ml 0.5%levobupivacaine(total-22ml)for the infraclavicular block and we measure the duration analgesia and VAS score measured at 0,1,2,4,6,8,12,18,24hrs and to compare the onset of sensory and motor block 
Intervention  Magnesium Sulfate  Patients will be receiving 2ml(200mg)10% Magnesium Sulfate with 20ml 0.5%levobupivacaine( total-22ml) for the infraclavicular block and we measure the duration of analgesia and VAS score measured at 0,1,2,4,6,8,12,18,24hrs and to compare onset of sensory and motor block 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients undergoing elective below Elbow orthopedic surgeries
2.Patient within the age group of 20 years to 60years
3.Patients under ASA I and II 
 
ExclusionCriteria 
Details  1.Patients under ASA III and ASA IV
2.Duration of surgery greater than 2hrs
3.Patients with coagulation disorders
4.Patient known allergic to local anesthetic agents
5.Skin infection at local sites
6.Patient refusal to give consent for the study.
7.If the block is inadequate and patient is converted into general anesthesia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of analgesia and (VISUAL ANALOG SCORE)VAS score and onset of sensory and motor block between Magnesium sulfate and Dexamethasone  0,1,2,4,6,8,12,18,24HRS postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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 3/ Phase 4 
Date of First Enrollment (India)   10/02/2025 
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="0"
Months="6"
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  

This prospective randomized double blind comparative study will be conducted at our institution over a period of 2 years. In this study 86 ASA grade I and II patients between age 20 years to 60 years with BMI <= 30kg/m2 posted for elective below elbow orthopaedic surgery requiring Ultrasound guided Infraclavicular block will be included.

After taking written informed consent from, patients will be randomized to 2 groups (n= 43 each ) by computer generated random number table. All patients will be thoroughly examined pre-operatively which includes blood pressure, heart rate, respiratory rate and systemic examination, and ASA grading. The patients with a contraindication to procedure like allergic reaction to local anesthetics or major neurological, cardiovascular, metabolic, respiratory, renal disease, or coagulation abnormalities will be excluded. 

After recording preoperative baseline Heart Rate and Blood Pressure  intravenous access is established using 18G cannula. Standard intraoperative monitoring includes ECG, NIBP, HR, and SPO2. Ringers lactate is used for replacement and maintenance fluid as per standard guidelines of perioperative fluid administration. The drug combination will be prepared by one anesthesiologist or pharmacist and will be given by another anesthesiologist who is blinded to the drug used in the study. Both the patients and the observer will be blinded to the study drug or the group.

Proper positioning for infraclavicular block with the patient supine and head turned to opposite side and arm abducted to 90 degree and the elbow fixed. Under all aseptic precautions Ultrasound guided Infraclavicular block is given in the below 2 groups 

In group M: The patients will be given 2ml of 10% Magnesium Sulfate with 20ml 0.5%levobupivacaine  in total 22ml solution

In group D: The patients will be given 2ml Dexamethasone with 20ml 0.5%levobupivacaine in total 22ml solution.

Onset time for sensory and motor block will be noted. The Sensory Block (SB) was assessed using pin prick test. All dermatomes supplied by radial, ulnar, median and musculocutaneous nerves were assessed. The SB was graded 0 = Normal sensation, 1=Loss of sensation to pin prick,2=Loss of touch sensation. The Motor Block (MB) was graded according to modified bromage scale which is 0=No movement in fingers, wrist and elbow, 1=Finger movement, 2=Flexion of wrist against gravity, 3=Flexion of elbow against gravity.

The onset time of SB is the time interval from injection of local anesthetic till the complete SB achieved. The duration of the SB is the time interval between onset of complete SB and complete resolution of SB. Duration of analgesia is the time between onset of complete SB and the first dose of post operative analgesia. The block is considered successful when sensory block is 2 and motor block is 0 within 30 min after local anesthetic is given, otherwise  block is considered as failed or inadequate.  

Post operative analgesia is achieved by giving diclofenac 75mg iv every 12hrs.

Pain assessment was done by using Visual Analogue Scale (VAS) which is expressed  on 11-point numerical scale 0-10 and recorded in the postoperative care unit at 0, 1, 2, 4, 6, 8, 12, 18, and 24 hours postoperative. 

0    = No pain (one extreme)

10  = Worst pain possible (other extreme)

 
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