| CTRI Number |
CTRI/2026/04/107677 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Evaluate a Simple, Non-Invasive Method for Assessing the Effectiveness of Arm nerve blocks |
|
Scientific Title of Study
|
Evaluation of Perfusion index as a tool for assessing efficacy Ultrasound-guided Brachial plexus block.
|
| 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.Lukalapu Ooha |
| Designation |
Pg Resident |
| Affiliation |
Career Institute Of Medical Sciences And Hospital Lucknow |
| Address |
Department of anaesthesia career institute of medical sciences and hospital
lucknow
iim road
ghaila
226013
Department of anaesthesia career institute of medical sciences and hospital
lucknow
iim road
ghaila
226013
Lucknow
UTTAR PRADESH
226013
India |
| Phone |
9177202334 |
| Fax |
|
| Email |
oohabhargavi9078@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. PRIYESH BHASKAR |
| Designation |
Professor And Head Of Department Of Anesthesiology |
| Affiliation |
Career Institute Of Medical Sciences And Hospital Lucknow |
| Address |
Department of anaesthesia career institute of medical sciences and hospital
lucknow
iim road
ghaila
226013
Department of anaesthesia career institute of medical sciences and hospital
lucknow
iim road
ghaila
226013
Lucknow
UTTAR PRADESH
226013
India |
| Phone |
7985975077 |
| Fax |
|
| Email |
drpriyeshlpsc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR LUKALAPU OOHA |
| Designation |
PG RESIDENT |
| Affiliation |
Career Institute Of Medical Sciences And Hospital Lucknow |
| Address |
Department of anaesthesia career institute of medical sciences and hospital
lucknow
iim road
ghaila
226013
Department of anaesthesia career institute of medical sciences and hospital
lucknow
iim road
ghaila
226013
Lucknow
UTTAR PRADESH
226013
India |
| Phone |
9177202334 |
| Fax |
|
| Email |
oohabhargavi9078@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Career Institute Of Medical Sciences And Hospital Lucknow |
| Address |
Department Of Anesthesiology Career Institute Of Medical Sciences And Hospital Lucknow IIM Road Ghaila Lucknow
Lucknow
UTTAR PRADESH
226013
India |
| 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 |
| DR OOHA LUKALAPU |
Career Institute Of Medical Sciences And Hospital |
Resident room no 1, Division 1, Department of Anesthesia, Operation Theatre Complex
Lucknow
UTTAR PRADESH
Lucknow
UTTAR PRADESH |
9177202334
oohabhargavi9078@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Career Institute Of Medical Sciences And Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender aged eighteen to sixty five years. Patients scheduled to undergo elective surgical procedures under general anaesthesia requiring endotracheal intubation. American Society of Anaesthesiologists physical status class one and two. Patients willing to give written informed consent. |
|
| ExclusionCriteria |
| Details |
Known allergy or hypersensitivity to Local anesthetics Coagulopathy or patients
on anticoagulant therapy,Infection or skin lesions
at the injection site, Pre-existing peripheral vascular disease or neuropathy
in the operative limb |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in perfusion index from baseline after brachial plexus block indicating block success. Time-dependent change in perfusion index used to predict successful brachial plexus block. Sensitivity of perfusion index in detecting successful ultrasound-guided brachial plexus block. |
At baseline 1,3,5,10,20, and 30 minutes after block administration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes include time to onset of sensory & motor blockade, comparison of perfusion index changes in successful versus failed blocks, & evaluation of the sensitivity & specificity of perfusion index in predicting block success. |
At baseline , 1,3,5,10,15,20, & 30minutes after block administration. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
17/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/04/2026 |
| 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 - NO
|
|
Brief Summary
|
Ultrasound-guided brachial plexus block is widely used for upper limb surgeries. Early and reliable assessment of block success is essential to ensure adequate anaesthesia and patient comfort. Perfusion index is a non-invasive parameter derived from pulse oximetry that reflects changes in peripheral blood flow and sympathetic blockade. This study aims to evaluates the usefulness of perfusion index as an objective tool for assessing the efficacy of ultrasound-guided brachial plexus block. Changes in perfusion index following the block will be recorded at predetermined time intervals and correlated with conventional clinical assessments of sensory and motor blockade. The findings may help in early prediction of block success and improve perioperative decision making. |