| CTRI Number |
CTRI/2022/02/040701 [Registered on: 28/02/2022] Trial Registered Prospectively |
| Last Modified On: |
28/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effectiveness of using ultrasound guided scalp block and local infiltration to decrease the pain during skull pin placement in craniotomy surgeries |
|
Scientific Title of Study
|
Comparison of the efficacy of ultrasound guided scalp block and local infiltration to blunt the hemodynamic response to skull pin placement during craniotomy surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gokul Das |
| Designation |
Associate professor |
| Affiliation |
Amrita Institute Of Medical Sciences |
| Address |
Dept of Anesthesiology
Amrita Institute Of Medical Sciences
Amrita Nagar, Ponekkara, Edapally
Ernakulam
KERALA
682041
India |
| Phone |
9847448005 |
| Fax |
|
| Email |
gokuldas75@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gokul Das |
| Designation |
Associate professor |
| Affiliation |
Amrita Institute Of Medical Sciences |
| Address |
Dept Of Anesthesiology
Amrita Institute Of Medical Sciences
Amrita Nagar, Ponekkara, Edapally
Ernakulam
KERALA
682041
India |
| Phone |
9847448005 |
| Fax |
|
| Email |
gokuldas75@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Susmitha Susan Mammen |
| Designation |
MD Resident |
| Affiliation |
Amrita Institute Of Medical Sciences |
| Address |
Dept Of Anesthesiology
Amrita Institute Of Medical Sciences
Amrita Nagar, Ponekkara, Edapally
Ernakulam
KERALA
682041
India |
| Phone |
09495916055 |
| Fax |
|
| Email |
susmithamammen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department fund
Dept of Anesthesiology
Amrita institute of Medical sciences
Ernakulam 682041 |
|
|
Primary Sponsor
|
| Name |
Amrita Hospital |
| Address |
Amrita institute of Medical sciences
Ponnekara Edapally Ernakulam
682041 |
| Type of Sponsor |
Private 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 |
| Gokukl Das |
Amrita Institute of Medical Sciences |
Dept of Anesthesiology
Amrita Nagar, Ponekkara, Edapally
Ernakulam
KERALA |
9847448005
gokuldas75@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C71||Malignant neoplasm of brain, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To study the efficacy of USG guided scalp block and local infiltration by comparing the number of patients requiring rescue analgesics to blunt the systolic blood pressure response at one minute following skull pin placement during craniotomy surgeries. |
One group of patients would receive scalp block before skull pin placement and other group would receive local infiltration to the site. The hemodynamic responses would be noted and the number of patients requiring rescue analgesics to blunt the response would be compared.
Duration of therapy- till the effect of local anesthesia |
| Comparator Agent |
To study the efficacy of USG guided scalp block and local infiltration by comparing the number of patients requiring rescue analgesics to blunt the systolic blood pressure response at one minute following skull pin placement during craniotomy surgeries. |
One group of patients would receive scalp block before skull pin placement and other group would receive local infiltration to the site. The hemodynamic responses would be noted and the number of patients requiring rescue analgesics to blunt the response would be compared. Duration of therapy- till the effect of local anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA I II and III patients
age group 18-75 years
undergoing craniotomy surgeries that use skull pin placement for fixation of head |
|
| ExclusionCriteria |
| Details |
Local infection
Allergy to the drug
Coagulopathy |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of USG guided scalp block and local infiltration by comparing the number of patients requiring rescue analgesics to blunt the systolic blood pressure response at one minute following skull pin placement during craniotomy surgeries. |
January 2022 to December 2022 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic changes (heart rate, systolic blood pressure, diastolic blood pressure and mean arterial blood pressure) after skull pin placement between USG guided scalp block and local infiltration at different time intervals (1,3,5,7, and 10 min) in patients undergoing craniotomy surgeries. |
January 2022 to December 2022 |
| To compare the total amount of rescue analgesics required during the 10 minutes following skull pin placement to blunt the hemodynamic response between USG guided scalp block and local infiltration in patients undergoing craniotomy surgeries. |
January 2022 to December 2022 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/03/2022 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Fixing the head using head clamps is an integral part of craniotomy surgeries. However, placement of pin is a very painful procedure. Various methods have been tried to blunt the hemodynamic response to pin placement. Local infiltration of anaesthetic agent by the surgeon at the site of pin placement is the most commonly used method. Scalp block is another method that can be used to reduce the response to pin placement and maybe the better method. In this randomised study, we will be looking forward to find if scalp block is a better method to blunt the hemodynamic response to skull pin placement compared to local infiltration by comparing the the number of patients who requires rescue analgesics following skull pin placement at 1min, 3 min, 5 min, 7 min and 10 min of pin placement. |