| CTRI Number |
CTRI/2023/07/055799 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| 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 compare the effect of scalp nerve block and local anaesthetic infiltration together and with local anaesthetic infiltration alone on inflammatory response in patients undergoing elective neurosurgery. |
|
Scientific Title of Study
|
Comparison of scalp nerve block and local anaesthetic infiltration with local anaesthetic infiltration alone on inflammatory response in patients undergoing elective neurosurgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya Gond |
| Designation |
Postgraduate Resident |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, ground floor ,main OT building,Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
DELHI
110029 India
Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
DELHI
110029 India
New Delhi
DELHI
110029
India |
| Phone |
8349666527 |
| Fax |
|
| Email |
Priyagg1993.pg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meenakshi Kumar |
| Designation |
Professor and consultant |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, ground floor, main OT building, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
DELHI
110029 India
New Delhi
DELHI
110029
India |
| Phone |
9899689829 |
| Fax |
|
| Email |
drmeenakshi86@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Meenakshi Kumar |
| Designation |
Professor and consultant |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, ground floor, main OT building, Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi
DELHI
110029 India
New Delhi
DELHI
110029
India |
| Phone |
9899689829 |
| Fax |
|
| Email |
drmeenakshi86@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and Safdarjung hospital,Ansari Nagar ,New Delhi,110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi 110029 |
| 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 |
| Priya Gond |
Vardhman Mahavir medical college and Safdarjung hospital |
Department of Anaesthesia, ground floor, main OT building ,Vardhman Mahavir medical college and Safdarjung hospital, Ansari Nagar, New Delhi 110029
New Delhi
DELHI |
8349666527
Priyagg1993.pg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir medical college and Safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, (2) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, (3) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Effect of Local anaesthetic infiltration alone on inflammatory response. |
Application of Local anaesthetic infiltration alone in patients undergoing elective neurosurgery under general anaesthesia and the inflammatory response will be studied by means of bio markers like CRP , IL6 and IL10. |
| Intervention |
Effect of Scalp nerve block and Local anaesthetic infiltration on inflammatory response |
Application of scalp nerve block and local anaesthetic infiltration in patients undergoing elective neurosurgery under general anaesthesia ,and the inflammatory response will be studied by means of bio markers like CRP, IL6 and IL10 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists physical status I-II Scheduled for elective neurosurgery. |
|
| ExclusionCriteria |
| Details |
1. Distorted surgical anatomy of Scalp.
2. Previous craniotomy incision.
3. History of allergy to opioids or local anaesthetics.
4. Unable to understand Visual Analog Scale. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare scalp nerve block & local anaesthetic infiltration with local anaesthetic infiltration alone in patients undergoing elective neurosurgery by means of bio markers C-Reactive Protein, Interleukin 6 & Interleukin 10 |
Baseline , Immediately postoperatively & at 24 hours of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare hemodynamic stability by means of heart rate & blood pressure ( mean arterial pressure)
|
A. Before Anaesthesia induction, 5 minutes after skin incision,during dura opening ,at the end of surgery |
| To compare the postoperative pain by means of Visual Analog Scale |
Immediately postoperative period & at 12 hours of surgery |
|
|
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)
|
07/08/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomised ,comparative, prospective ,interventional study where we are comparing effect of scalp nerve block and local anaesthetic infiltration in one group and in other group only the effect of local anaesthetic infiltration alone will be studied on inflammatory response in patients undergoing elective neurosurgery under general anaesthesia by means of bio markers like c reactive protein , interleukin 6 and interleukin 10 as the primary outcome. Secondary outcome will be studied from hemodynamic stability by means of heart rate and blood pressure and comparing postoperative pain by means of visual analog scale. In this study with this parameters , we are hypothesising that scalp nerve block and local anaesthetic infiltration together are superior to local anaesthetic infiltration alone in controlling inflammatory response , maintaining hemodynamic stability and relieving postoperative pain.Primarily inflammatory response will be measured by means of c recative protein , interleukin 6 and interleukin 10 first as baseline then immediately in postoperative period then at 24 hours of surgery , secondarily hemodynamic stability measured by means of heart rate and blood pressure before anaesthesia induction, 5 minutes after skin incision, during dura opening,at the end of surgery and postoperative pain compared immediately in postoperative period and at 12 hours of surgery. |