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CTRI Number  CTRI/2024/10/075811 [Registered on: 24/10/2024] Trial Registered Prospectively
Last Modified On: 21/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Which method of scalp block is better in providing intraoperative and post operative pain control and patient blood pressure stability- Landmark or field block method of scalp block for patients undergoing craniotomy under general anaesthesia. 
Scientific Title of Study   A comparison of two methods of scalp block:Landmark vs field block for patients undergoing craniotomy under general anaesthesia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amit Kumar Singh 
Designation  PG Resident 
Affiliation  Dept of Anaesthesiology,Command Hospital( Eastern Command) 
Address  Dept of Anaesthesiology,Command Hospital(Eastern Command), Alipore, Kolkata-700027

Kolkata
WEST BENGAL
700027
India 
Phone  08880892266  
Fax    
Email  aksingh407@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Surg Capt( Dr.) Umesh Kumar Dash 
Designation  Professor 
Affiliation  Dept of Anaesthesiology,Command Hospital( Eastern Command) 
Address  Dept of Anaesthesiology,2nd Floor, Command Hospital (Eastern Command), Alipore Road, Kolkata

Kolkata
WEST BENGAL
700027
India 
Phone  8779478574  
Fax    
Email  gasdoc2001@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Amit Kumar Singh 
Designation  PG Resident 
Affiliation  Dept of Anaesthesiology,Command Hospital( Eastern Command) 
Address  Dept of Anaesthesiology,Command Hospital(Eastern Command), Alipore, Kolkata-700027

Kolkata
WEST BENGAL
700027
India 
Phone  08880892266  
Fax    
Email  aksingh407@gmail.com  
 
Source of Monetary or Material Support  
Command Hospital(Eastern Command),Alipore, Kolkata-700027 
 
Primary Sponsor  
Name  Commad Hospital(Eastern Command) 
Address  Dept of Anaesthesiology,Command Hospital(Eastern Command), Alipore, Kolkata-700027 
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 Amit Kumar Singh  Command Hospital (Eastern Command)  Intensive Care Unit and Operation Theatre, Dept of Anaesthesiology and Critical Care,2nd Floor.
Kolkata
WEST BENGAL 		 08880892266

aksingh407@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Command Hospital(EC),Alipore,Kolkata-27  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Scalp Block by Field block method  20 ml of Inj Bupivacaine(0.25 %) will be used for scalp block by Field Block method of Scalp Block pre-operatively for patients undergoing craniotomy or craniectomy under general anaesthesia for duration of 18 months starting from first recruitment. 
Intervention  Scalp block by Landmark method  20 ml of Inj Bupivacaine(0.25 %) will be used for scalp block by Landmark method of Scalp Block pre-operatively for patients undergoing craniotomy or craniectomy under general anaesthesia for duration of 18 months starting from first recruitment. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients under ASA I-III who are undergoing craniotomy/craniectomy under general anaesthesia will be included 
 
ExclusionCriteria 
Details  Patients with coagulopathies,infection at skin overlying scalp area,history of allergy to the drug which will be used in scalp block,unwillingness, patients on long term pain management and haemodynamically unstable patients will be excluded 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Hemodynamic response during anaesthesia and surgery  Heart Rate and Mean Arterial Pressure ( MAP) during skull pin, incision, burr hole drilling, bone flap removal, dural incision and skin closure.
Visual Analogue Score at 6,12 and 24 hours after infiltration of Scalp BLock. 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of analgesia and cumulative dose of analgesic used post of till 24 hours.  Visual Analogue Score will be measured at 6,12 and 24 hoours post infiltration of scalp block 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/11/2024 
Date of Study Completion (India) 14/03/2026 
Date of First Enrollment (Global)  04/11/2024 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included will be given once the study got published).

  6. For how long will this data be available start date provided 30-09-2024 and end date provided 28-06-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
 The insertion of pins of skull holder to stabilize the head during craniotomy/craniectomy and other procedure like skin incison,skull drilling,skul flap removal ,dura incision produces lots of periosteal reaction and results in haemodynamic response which may lead to brain oedema,intracranial hypertension which can lead to adverse post operative outcome. The aim of the study is to compare the effectiveness scalp block by landmark and field block technique in patients undergoing craniotomy/craniectomy under general anaesthesia in terms of intraoperative haemodynamic stability( HR and MAP) and quality & duration of analgesia provided (Visual  Analogue Score at 6,12 and 24 hours post infiltration )by field block method and landmark method of scalp block
 
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