| CTRI Number |
CTRI/2025/06/088210 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing two pain relief methods during surgery,Blocking the scalp nerves and Local anesthetic injection,to see which one Keeps blood pressure stable during surgery and Reduces pain after surgery |
|
Scientific Title of Study
|
EFFECT OF SCALP NERVE BLOCK VERSUS LOCAL ANAESTHETIC INFILTRATION ON INTRAOPERATIVE HAEMODYNAMICS AND POSTOPERATIVE PAIN IN PATIENTS UNDERGOING CRANIOTOMY-AN OBSERVATIONAL STUDY |
| 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 Parvathi O |
| Designation |
Junior Resident |
| Affiliation |
Govt. Medical College, Kozhikode |
| Address |
Neurosurgery theatre
Major Operation Theatre
Department of Anaesthesiology
Government Medical College
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
7034126830 |
| Fax |
|
| Email |
paruvis326@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Biji K P |
| Designation |
Professor,Dept of Anaesthesiology |
| Affiliation |
Govt. Medical College, Kozhikode |
| Address |
Neurosurgery theatre
Major Operation Theatre
Government Medical College
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
7034126830 |
| Fax |
|
| Email |
drbijikp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parvathi O |
| Designation |
Junior Resident,Dept of Anaesthesiology |
| Affiliation |
Govt. Medical College, Kozhikode |
| Address |
Neurosurgery theatre
Major Operation Theatre
Government Medical College
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
7034126830 |
| Fax |
|
| Email |
paruvis326@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neurosurgery theatre, Major Operation Theatre Complex, Government Medical College
Kozhikode, Pin:673008, Kerala, India
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Neurosurgery theatre, Major Operation Theatre Complex, Department of Anaesthesiology, Government medical College
Kozhikode, Kerala, India |
| 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 Parvathi O |
Government Medical College, Kozhikode |
Neurosurgery Theatre
Major Operation Theatre Complex
Kozhikode
KERALA |
7034126830
paruvis326@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt.Medical College, Kozhikode |
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 infiltration
|
Both pin site and incision site infiltrated with mixture of 10mL 2 percentage lignocaine with 1 in 2 lakh adrenaline+10 ml 0.5 percentage bupivacaine |
| Intervention |
Scalp nerves block |
Scalp nerves block administered by identifying 4 nerves supplying scalp with help of bony landmarks and injecting drug - 10mL 2 percentage lignocaine with 1 in 2 lakh adrenaline + 10ml 0.5 percentage bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients posted for elective craniotomy
2)Age between 18-65 years
3)American Society of Anaesthesiologists 1&2
4)Duration of surgery 3-5hours
5)Height of patient between 150-180cm and weight between 50 - 80kg |
|
| ExclusionCriteria |
| Details |
1)History of allergy to local anaesthetics or opiods |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraoperative heart rates and mean arterial pressure |
T1-just before induction
T2-5 mins after induction
T3-2 mins after pin insertion
T4-5 mins after pin insertion
T5-2 mins after incision
T6-5 mins after incision
T7-During drilling
T8-During dura opening
T9-At the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain in terms of duration of analgesia and 24 hour morphine consumption |
Arrival at post anaesthetic care unit
2nd hour
4th hour
6th hour
8th hour
10th hour
12th hour
14th hour
16th hour
18th hour
20th hour
22 nd hour
24th hour |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
15/08/2025 |
| 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 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 - All of the individual participant data collected during the trial, after de-identification.
- 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
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mevishnukv1@gmail.com].
- For how long will this data be available start date provided 22-07-2025 and end date provided 22-07-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
70 patients selected according to inclusion and exclusion criteria.Patients receiving scalp block included in group SB.Patients receiving local infiltration included in group LI.After induction of general anaesthesia intraoperative heart rate , invasive blood pressure recorded.Postoperative pain assessed by Numerical Rating Score on arrival to post anaesthetic care unit and 2 hourly intervals. 24 hour morphine consumption also noted.Data entered in Excel sheet and analysed using IBM SPSS software version 22 for windows. |