| CTRI Number |
CTRI/2024/06/068881 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to predict Successful regional block by non invasive method |
|
Scientific Title of Study
|
A STUDY TO EVALUATE THE CHANGE IN PERFUSION INDEX AS AN INDICATOR OF EFFICIENT ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK IN PEDIATRIC PATIENTS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Praveen Petson |
| Designation |
Resident |
| Affiliation |
LLRM Medical College |
| Address |
LLRM Medical College,Ground floor, Room No G-12, Dept. of Anaesthesiology
LLRM Medical College, Jagrati Vihar, Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9894559911 |
| Fax |
- |
| Email |
petsonb4u@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Abhishek Goel |
| Designation |
Assosiate Professor |
| Affiliation |
LLRM Medical College |
| Address |
102- Consultants Quarters
Behind Pharmacy Department
Dept. of Anaesthesiology
LLRM Medical College, Jagrati Vihar, Meerut
UTTAR PRADESH
250004
India |
| Phone |
9927951681 |
| Fax |
- |
| Email |
dr_abhishek1979@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Praveen Petson |
| Designation |
Resident |
| Affiliation |
LLRM Medical College |
| Address |
LLRM Medical College,
Department of Anaesthesiology, Ground floor, Room No-G-12,
Beside IT parking,
Garh Road,
Jagrati Vihar, Meerut
UTTAR PRADESH
250004
India |
| Phone |
9894559911 |
| Fax |
- |
| Email |
petsonb4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Ground floor, Room No G-12, Near IT Parking, LLRM Medical College, SVBP Hospital, Meerut, Uttar Pradesh, 250004, India |
|
|
Primary Sponsor
|
| Name |
Dr Praveen Petson |
| Address |
LLRM Medical College |
| Type of Sponsor |
Other [Self] |
|
|
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 Praveen Petson |
Sardar Vallabai Patel Hospital |
Room No. 14 Ground floor, Beside IT Parking, Department of Anaesthesiology, LLRM Medical College
Meerut
UTTAR PRADESH |
9894559911
petsonb4u@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Not Applicable |
|
|
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 |
Inj. ROPIVACAINE 0.75% 3mg/kg |
Block effect will be assessed at
5 minute
10 minute
20 minute 30 minute |
| Comparator Agent |
Perfusion Index (PI) |
After the block, PI index will be assessed at
5 minute
10 minute
20 minute 30 minute |
| Intervention |
USG Guided Supra clavicular block |
Outcome will be assessed at 0 minute
5 minute
10 minute
20 minute 30 minute |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Grade I and II Patients
2. Patient undergoing elective upper limb surgeries
3. Patient with informed consent |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes are that
- Perfusion Index is expected to increase after supraclavicular brachial plexus block due to sympathetic blockade & vasodilation. |
Outcome will be assessed at
0 minute
5 minute
10 minute
20 minute
30 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to calculate the cut off value for PI for a successful Supraclavicular Block |
The secondary outcome will be assessed at
0 minute
5 minutes
10 minutes
20 minutes
30 minutes |
| To calculate any complication associated with the block |
The secondary outcome will be assessed at
0 minute
5 minutes
10 minutes
20 minutes
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/06/2024 |
| 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
|
The perfusion index (PI) is a straightforward, objective, and non-invasive measure for assessing success. It serves as a marker of peripheral perfusion and as an index of sympathetic stimulation. After brachial plexus block, PI is expected to increase at least 3 times from the base line PI.
This study can be helpful in pediatric patients as in most cases they will be sedated prior to block and can depend on PI as an indicator of efficient successful supra-clavicular block. |