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CTRI Number  CTRI/2015/07/005979 [Registered on: 07/07/2015] Trial Registered Retrospectively
Last Modified On: 20/08/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of two doses of Magnesium Sulphate as adjuvant in USG guided supraclavicular block.  
Scientific Title of Study   MAGNESIUM SULPHATE IN TWO DIFFERENT DOSES AS AN ADJUNCT TO BUPIVACAINE FOR ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK A RANDOMISED CONTROLLED STUDY  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saloni Sood 
Designation  Junior Resident 
Affiliation  Post Graduate Student(MD Anaesthesia) Dr RPGMC Kangra at Tanda 
Address  DEPARTMENT OF ANESTHESIA Dr RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE KANGRA AT TANDA DISTT KANGRA
DEPARTMENT OF ANESTHESIA Dr RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE KANGRA AT TANDA DISTT KANGRA
Kangra
HIMACHAL PRADESH
176001
India 
Phone  9459147712  
Fax  01892-267115  
Email  salonidynamic7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shelly Rana 
Designation  Associate Professor 
Affiliation  Associate Professor(MD.,DNB Anaesthesia).DRPGMC,Tanda At Kangra 
Address  Associate Professor,Deptt. of Anesthesia. DR RPGMC Kangra At Tanda. PIN 176001
Associate Professor,Deptt. of Anesthesia. DR RPGMC Kangra At Tanda. PIN 176001
Kangra
HIMACHAL PRADESH
176001
India 
Phone  9418113786  
Fax  01892-267115  
Email  shelkbj@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shelly Rana 
Designation  Associate professor 
Affiliation  Associate Professor(MD.,DNB Anaesthesia).DRPGMC,Tanda At Kangra 
Address  Deptt of Anesthesia DR RPGMC Kangra At Tanda.PIN 176001
Deptt of Anesthesia DR RPGMC Kangra At Tanda.PIN 176001
Kangra
HIMACHAL PRADESH
176001
India 
Phone  9418113786  
Fax  01892-267115  
Email  shelkbj@yahoo.com  
 
Source of Monetary or Material Support  
none 
 
Primary Sponsor  
Name  RPGMC TANDA 
Address  DR RPGMC KANGRA AT TANDA 
Type of Sponsor  Government 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 SALONI SOOD  Orthopaedics Operation Theatre 1,2 ,Floor 2.OT Complex  DR RPGMC Kangra at Tanda
Kangra
HIMACHAL PRADESH 		 9459147712
01892-267115
salonidynamic7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethical comittee DRRPGMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PATIENTS POSTED FOR SURGERY OF ORTHOPEDIC INJURIES AROUND ELBOW, FOREARM AND HAND ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  magnesium sulphate in two different doses  two doses 125 and 250 mg of magnesium sulphate are used 
Intervention  Magnesium Sulphate(125mg vs 250mg) As An Adjuvant To Bupivacaine in USG Guided Supraclavicular block  USG Guided Supraclavicular Block Control Group: 20 ml of 0.5% Bupivacaine + 5 ml of Normal Saline Group BM0.5: 20 ml of bupivacaine0.5%+1.25 ml of MGSO4+ 3.75ml of normal Saline Group BM1: 20 ml of bupivacaine 0.5%+ 2.5 ml of MGSO4+ 2.5ml of normal Saline 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Males and females between the age group 1. 1.MALES AND FEMALES BETWEEN AGE 20-60 years.
2. ASA class I-II.
3. BMI 18.5-39.9.
4. Undergoing surgeries of elbow forearm and hand.
 
 
ExclusionCriteria 
Details  1. Patient’s refusal for block.
1. History of cardiac, renal or hepatic disease.
2. Patients of CNS disorders or neuropathy.
3. Chronic treatment with calcium channel blockers.
4. Patients having bleeding disorders.
5. Hypersensitivity to local anaesthetics
6. Local infection at the site where needle for block is to be inserted.
7. Shoulder surgery
8. Allergic to study drugs.
9. Patients in whom the block effect will be partial and will require supplementary anesthesia

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of postoperative analgesia and total number of rescue analgesics in the postopertive period following USG guided supraclavicular block in three groups   the primary outcome was assessed over a period of 24 hours postoperatively at the
interval of 2 hours 
 
Secondary Outcome  
Outcome  TimePoints 
• To evaluate and compare the onset, duration of sensory and motor blockade with bupivacaine alone and with magnesium sulphate in two different doses.
• To study and compare the duration of postoperative analgesia in three groups of patients.
• To observe for side effects of magnesium sulphate, if any
 		 NIL 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/12/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="8"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   90 PATIENTS WHO ARE SCHEDULED FOR SURGERIES OF ARM FOREARM AND ELBOW WERE ENROLLED INTO THREE GROUPS .ONE GROUP RECEVIED PLAIN BUPIVACAINE  AND OTHER TWO RECEIVED 0.5% AND 1% CONCENTRATIONS OF MAGNESIUM SULAPHTE ALONG WITH BUPIVACAINE IN ULTRASOUND GUIDED SUPRACLAVICULAR BLOCK.THE ONSET OF SENSORY AND MOTOR BLOCK ,THE DURATION OF SENSORY AND MOTOR BLOCKADE AND TIME FOR DEMANDING FIRST RESCUE ANALGESIA  IS CALCULATED IN EACH GROUP. 
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