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CTRI Number  CTRI/2022/03/041098 [Registered on: 15/03/2022] Trial Registered Prospectively
Last Modified On: 14/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of pain scores using dexmedetomidine with bupivacaine , ketamine with bupivacaine and plain bupivacaine in scalp block 
Scientific Title of Study   COMPARISON OF ANALGESIC EFFICACY AND DURATION OF SCALP BLOCK USING KETAMINE AND DEXMEDETOMIDINE AS ADJUVANTS TO BUPIVACAINE- A PROSPECTIVE, RANDOMIZED DOUBLE-BLIND STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swati Gupta 
Designation  Resident 
Affiliation  Mahatma Gandhi Medical College 
Address  Mahatma Gandhi Medical College & Hospital Ricco Industrial Area Sitapura Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9621103819  
Fax    
Email  gupta.swati0922@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudhir Sachdev 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College 
Address  Mahatma Gandhi Medical College & Hospital Ricco Industrial Area Sitapura Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9829055666  
Fax    
Email  drsudhirmgmch@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Durga Jethava 
Designation  HOD Professor 
Affiliation  Mahatma Gandhi Medical College 
Address  Mahatma Gandhi Medical College & Hospital Ricco Industrial Area Sitapura Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9680064336  
Fax    
Email  djethava@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College & Hospital, Jaipur 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College Hospital Jaipur 
Address  Mahatma Gandhi Medical College & Hospital, Riico industrial area, sitapura, tonk road, jaipur 
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 Durga Jethava  Neuro surgery OT, Dept of Anesthesia  Mahatma Gandhi Hospital Ricco Industrial Area Sitapura Jaipur
Jaipur
RAJASTHAN 		 9680064336

gupta.swati0922@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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  bupivacaine dexmedetomidine ketamine  block given with plain bupivacaine 0.25% (28ml + 2ml normal saline) block given with bupivacaine 0.25% (28ml) + (0.5ml) dexmedetomidine + (1.5ml) normal saline block given with bupivacaine 0.25% (28ml) + (2ml) ketamine route of administration: subcutaneously given at the start of surgery once. 
Intervention  scalp block  given at 5 points. 1. supraorbital 2.supratrochlear 3.zygomaticotemporal 4. greater occipital 5. lesser occipital 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patient fulfilling criteria of American Society of Anesthesiology (ASA) of Classes I/ II
2) Patient aged 18-65 years of both sexes.
3) Patients undergoing elective supratentorial craniotomy under general anaesthesia.
4) Patients giving consent willingly. 
 
ExclusionCriteria 
Details  Patient with ASA CLASS III, IV & V
● Refusal of patient
● Patient with difficult surgical anatomy
● Patient with previous craniotomy incision
● Local infection at the site of injection
● History of allergy to opioid or local anaesthesia
● Inability to comprehend or participate in pain scoring system.
Intended 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1) To assess the analgesic efficacy and duration of scalp block using bupivacaine.
2) To assess the analgesic efficacy and duration of scalp block using bupivacaine with dexmedetomidine.
3) To assess the analgesic efficacy and duration of scalp block using bupivacaine with ketamine.
4) To compare the analgesic efficacy and duration of scalp block in all three groups. 		 intra operatively
post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
none  NA 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   30/03/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/03/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Anaesthesia for craniotomy requires special considerations. uncontrolled post operative and intraoperative pain can lead to increase in intracranial pressure.
Methods like scalp block therefore are being used to blunt hemodynamic response to pain in craniotomies, decrease opioid consumption and reduce post operative pain consumption.
We are using adjuvants like ketamine and dexmedetomidine with bupivacaine to compare the analgesic efficacy and effectiveness of scalp block. 
 
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