| CTRI Number |
CTRI/2025/11/098123 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Measuring finger blood flow to predict whether a nerve block in the shoulder area will work in adults.
|
|
Scientific Title of Study
|
Predicting successful supraclavicular brachial plexus block in adults using pulse oximetry perfusion index: a prospective 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 |
Durga |
| Designation |
PG Scholar |
| Affiliation |
SRM Institute of Science and Technology, |
| Address |
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar, Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar, Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
Chennai
TAMIL NADU
603203
India |
| Phone |
9566109948 |
| Fax |
|
| Email |
dv6553@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karthik K |
| Designation |
Associate Professor |
| Affiliation |
SRM Institute of Science and Technology, |
| Address |
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar, Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar, Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
TAMIL NADU
603203
India |
| Phone |
9444586662 |
| Fax |
|
| Email |
karthikk1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Durga |
| Designation |
PG Scholar |
| Affiliation |
SRM Institute of Science and Technology, |
| Address |
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar, Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar, Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
TAMIL NADU
603203
India |
| Phone |
9566109948 |
| Fax |
|
| Email |
dv6553@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SRM Institute of Science and Technology |
| Address |
SRM Institute of Science and Technology, Kattankulathur, Chengalpattu District, Tamil Nadu – 603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Karthik K |
SRM medical college and research institute |
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
Chennai
TAMIL NADU |
9444586662
karthikk1@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM medical college hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M973||Periprosthetic fracture around internal prosthetic shoulder joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing elective upper limb procedures under ultrasound-guided supraclavicular nerve block.
Patient providing written informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Unwilling patient.
Patient with diabetes mellitus and peripheral vascular disease.
Patient with anatomical deformities of upper limb.
Vascular injury due to fracture of the limb
Presence of edema in the limb to be block.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study is expected to establish the perfusion index (PI) as a reliable, non-invasive, and objective tool for the early prediction of successful supraclavicular brachial plexus block, potentially enabling faster clinical decision-making and improved patient care.
|
2, 4, 6, 8, 10, 15, 20, 25 and 30 minutes.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
17/12/2025 |
| 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="0"
Months="7"
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 aims to assess whether changes in the perfusion index measured by pulse oximetry can predict the success of supraclavicular brachial plexus block in adult patients. The study will include adults scheduled for upper limb surgery and analgesia under ultrasound guided supraclavicular block. Perfusion index values will be recorded before the block and at several time points after the injection of local anesthetic. The clinical success of the block will be assessed using standard sensory and motor testing. The study will compare perfusion index changes between successful and failed blocks and will determine the time point and cutoff value that best predicts block success. The findings may help clinicians identify early whether the block is effective. |