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CTRI Number  CTRI/2025/10/096350 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 18/10/2025
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   To know the effect of Scalp nerve block on laboratory blood investigations in patients undergoing Brain surgeries 
Scientific Title of Study   Comparison of effects of Scalp Nerve Block versus Local Anaesthetic infiltration on inflammatory response in patients undergoing Craniotomy- A Randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Siddalingesh N Hiremath 
Designation  Post-graduate student 
Affiliation  Bangalore Medical College and Research Institute 
Address  Major OT Complex Department of Anaesthesia Victoria Hospital KR Road, FORT Bengaluru
Major OT Complex Department of Anaesthesia Victoria Hospital KR Road, FORT Bengaluru
Bangalore
KARNATAKA
560002
India 
Phone  7022080504  
Fax    
Email  drsiddalingeshnhiremath@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swathi N 
Designation  Assistant Professor 
Affiliation  Bangalore Medical College and Research Institute 
Address  Major OT Complex Department of Anaesthesia Victoria Hospital KR Road, Fort Bengaluru
Major OT Complex Department of Anaesthesia Victoria Hospital KR Road, Fort Bengaluru
Bangalore
KARNATAKA
560002
India 
Phone  9972454989  
Fax    
Email  swathisaggi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swathi N 
Designation  Assistant Professor 
Affiliation  Bangalore Medical College and Research Institute 
Address  Major OT Complex Department of Anaesthesia Victoria Hospital KR Road, Fort Bengaluru
Major OT Complex Department of Anaesthesia Victoria Hospital KR Road, Fort Bengaluru
Bangalore
KARNATAKA
560002
India 
Phone  9972454989  
Fax    
Email  swathisaggi@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Bangalore Medical College and Research Institute 
Address  Major OT complex Victoria hospital KR Road FORT Bangalore 
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 Siddalingesh N Hiremath  Bangalore Medical College and Research Institute  Centenary building, Main OT Complex, KR ROAD, FORT Bangalore
Bangalore
KARNATAKA 
7022080504

drsiddhalingeshnhiremath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE 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  Local Anaesthetic infiltration  Surgical incision and skull pinning sites will be infiltrated with 15ml of 0.25% Ropivacaine 
Intervention  Scalp Nerve Block  Inj Ropivacaine 0.25% 15cc given bilaterally over the scalp to block supra-orbital nerve, supratr-trochlear nerve,zygomatico-temporal nerve, auriculo-temporal nerve, lesser occipital nerve and greater occipital nerve  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients willing to give written informed consent.
2.Patients between the age 18-65 years, undergoing Craniotomy.
3.Patients belonging to ASA physical status I and II. 
 
ExclusionCriteria 
Details  1. Patients posted for re-exploration  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the effect of Scalp block versus Local infiltration in patients
undergoing craniotomies on NLR post- operatively 
Pre-operative CBC
Post-operative 24hours and 48hours CBC 
 
Secondary Outcome  
Outcome  TimePoints 
To study the effect of Scalp block versus Local infiltration in patients undergoing craniotomies on PLR post-operatively. To study hemodynamic responses, VAS score between 2 groups  Pre-operative CBC
Post-operative 24hours and 48hours CBC 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   31/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/10/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [swathisaggi@gmail.com].

  6. For how long will this data be available start date provided 27-01-2027 and end date provided 31-05-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - swathisaggi@gmail.com
Brief Summary  

Craniotomies are often associated with significant perioperative stress response, leading to alterations in neuro-endocrine hormones and cytokines and hence linked to poor neurological outcomes, increased post-operative complications like mortality and longer intensive care unit and hospital stays. The immune response is influenced by the type of surgery as well as the anaesthetic technique.

 

            The immune responses can be measured by changes in differential counts, lymphocytes subsets, plasma concentrations of pro-inflammatory cytokines(Interleukin-2, IL-6, IL-12, Interferon-g) and anti-inflammatory cytokines(IL-10, transforming growth factor b) and plasma concentrations of cortisol, epinephrine and nor epinephrine measured before and after surgery.

 Neutrophils-to-lymphocyte ratio (NLR) and Platelets-to-lymphocyte ratio (PLR) derived from routine complete blood count tests have emerged as a simple reliable biological marker and cost effective for evaluating systemic inflammation, stress response, and predicting outcome in various surgical populations.

            In the context of craniotomy, alterations in NLR and PLR may also serve as surrogate markers for the degree of perioperative stress and inflammation as in various other clinical conditions such as sepsis, cardiovascular diseases and malignancies. 

            Regional anaesthesia has been speculated to decrease the inflammatory and immunosuppressive responses.Scalp nerve block(SNB) and local anaesthetic infiltration(LI) of the scalp have been proposed to blunt hemodynamic response to craniotomy, reduced anaesthetic requirements, decrease opioid consumption, and reduce postoperative pain perception during craniotomies. In addition, SNB has been shown to attenuate the neuroendocrine stress response by reducing sympathetic activation and inflammatory mediator release. This is probably due to blockade of C-fibres carrying pain and hence reduced activity of sympathetic nerve fibres. 

           Since there is limited evidence of studies comparing the impact of SNB and LI on post-operative inflammatory response, we intended to study their effect on NLR and PLR 24 & 48 hours post-operatively in patients undergoing craniotomies.  

 
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