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CTRI Number  CTRI/2018/07/014747 [Registered on: 05/07/2018] Trial Registered Prospectively
Last Modified On: 04/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Use of magnesium sulphate as an adjuvant to ropivacaine in pectoral nerve block 
Scientific Title of Study   Evaluation of analgesic effect of magnesium sulphate as an adjuvant to ropivacaine in pectoral nerve block. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harmanpreet Kaur Jhand 
Designation  Junior Resident 
Affiliation  GGS MEDICAL COLLEGE, FARIDKOT 
Address  Department of Anaesthesiology, 2nd floor, GGS Medical College and Hospital, Faridkot

Amritsar
PUNJAB
151203
India 
Phone  8872053215  
Fax    
Email  harmanpreet1035@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naresh Baghla 
Designation  Professor and Head of Department 
Affiliation  GGS Medical College and Hospital, Faridkot 
Address  Dr Naresh Baghla, Professor and Head of Department, Department of Anaesthesiology, GGS Medical College and Hospital.

Faridkot
PUNJAB
151203
India 
Phone  9814035236  
Fax    
Email  drbaghla@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Naresh Baghla 
Designation  Professor and Head of Department 
Affiliation  GGS Medical College and Hospital, Faridkot 
Address  Dr Naresh Baghla, Professor and Head of Department, Department of Anaesthesiology, GGS Medical College and Hospital.

Faridkot
PUNJAB
151203
India 
Phone  9814035236  
Fax    
Email  drbaghla@yahoo.com  
 
Source of Monetary or Material Support  
GGS Medical College & Hospital, Faridkot. 
 
Primary Sponsor  
Name  Dr Harmanpreet Kaur Jhand 
Address  Department of Anaesthesiology, 2nd floor, GGS Medical College and Hospital, Faridkot 
Type of Sponsor  Other [] 
 
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 Harmanpreet Kaur Jhand  GGS Medical College and Hospital, Faridkot  Department of Anaesthesiology, GGS Medical College and Hospital, Faridkot
Faridkot
PUNJAB 		 8872053215

harmanpreet1035@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Thesis and Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Female patients of age between 18 to 65 years, undergoing modified radical mastectomy (MRM) surgery under general anaesthesia.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ropivacaine  Ropivacaine is a relatively new long acting amide local anaesthetic, that is structurally related to bupivacaine. 
Comparator Agent  Ropivacaine and magnesium sulphate  Magnesium sulphate as an adjuvant with local anaesthetics enhances both duration and quality of analgesia during peripheral nerve block and nerve plexus blockade. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  American Society of Anaesthesiologists’ Grade I and II patients.
Patients of age between 18 to 65 years, undergoing modified radical mastectomy (MRM) surgery under general anaesthesia (GA). Patients willing to give informed written consent.

 
 
ExclusionCriteria 
Details  Patients with any contraindication to regional anesthesia or history of anaphylaxis to local anaesthetics or allergy to the study drugs. ASA-III & ASA-IV patients.
Pregnant or lactating patients.
Patient’s refusal for Pectoral nerve block.

 
 
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 evaluate and compare analgesic effect of magnesium sulphate 150mg as an adjuvant to 0.25% ropivacaine versus 0.25% ropivacaine alone in pectoral nerve block in terms of:
Duration of post-operative analgesia.
Total analgesic consumption in 24 hours post-operatively. 		 To evaluate and compare analgesic effect of magnesium sulphate 150mg as an adjuvant to 0.25% ropivacaine versus 0.25% ropivacaine alone in pectoral nerve block in terms of:
Duration of post-operative analgesia.
Total analgesic consumption in 24 hours post-operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
To record any side effects and patient satisfaction score  Side effects
Patient satisfaction score 
 
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   N/A 
Date of First Enrollment (India)   12/07/2018 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Introduction: The pectoral nerve (PECS) block, first described by Blanco et al., is an interfascial plane block. It is a safe and inexpensive technique with the advantages of providing ideal operating conditions and effective post-operative analgesia.
The study will be conducted in a randomized manner in the Department of Anaesthesiology, G.G.S. Medical College and Hospital, Faridkot on 60 adult female patients of age between 18 to 65 years, American Society of Anaesthesiologists’ (ASA) Grade I and II, scheduled to undergo modified radical mastectomy under general anaesthesia (GA) with pectoral nerve block. The patients will be randomly allocated into 2 groups of 30 patients each.
Group A: Patients will receive 30 ml of drug volume of 0.25% ropivacaine with 10 ml of normal saline as placebo.
Group B: Patients will receive 30 ml of drug volume of 0.25% ropivacaine with 150 mg of magnesium sulphate diluted to 10 ml of normal saline.
Duration of post-operative analgesia, total analgesic consumption in 24 hours post-operatively, patient satisfaction score and side effects will be assessed in both the groups. The data will then be statistically analyzed.  
 
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