| 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
|
|
|
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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [swathisaggi@gmail.com].
- 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.
- 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. |