| CTRI Number |
CTRI/2026/04/109189 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Peripheral Perfusion Index as an early indicator of successful ultrasound guided supraclavicular block in upper limb surgeries. |
|
Scientific Title of Study
|
Perfusion Index as an early indicator of successful ultrasound guided supraclavicular block in upper limb surgeries. |
| 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 Akansha Singh |
| Designation |
Junior Resident |
| Affiliation |
Dr. D. Y. Patil Medical college, Hospital and Research Center. |
| Address |
Department of Anaesthesia, Dr. D. Y. Patil Medical college, Hospital and Research Center. Pimpri-Chinchwad, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9918344419 |
| Fax |
|
| Email |
akanshasingh71303@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subha Teresa Jose Vazhakalayil |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil Medical college, Hospital and Research Center. |
| Address |
Department of Anaesthesia, Dr. D. Y. Patil Medical college, Hospital and Research Center. Pimpri-Chinchwad, Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9558224077 |
| Fax |
|
| Email |
dr.subhajose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subha Teresa Jose Vazhakalayil |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil Medical college, Hospital and Research Center. |
| Address |
Department of Anaesthesia, Dr. D. Y. Patil Medical college, Hospital and Research Center. Pimpri-Chinchwad, Pune.
MAHARASHTRA
411018
India |
| Phone |
9558224077 |
| Fax |
|
| Email |
dr.subhajose@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Akansha Singh |
| Address |
Department of Anaesthesia, Hitech building, Dr. D.Y. Patil medical College, Hospital and
research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India, pin code-411018. |
| 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 Deshpande |
Dr. D. Y. Patil Medical college, hospital and Research centre. |
Department of Anaesthesia, Dr. D.Y. Patil medical College, Hospital and
research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India, pin code-411018.
Pune
MAHARASHTRA |
09767505311
hg.deshpande@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-committee |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I or II fit patients, Patients undergoing upper limb surgeries under supraclavicular block, Hemodynamically stable patients with all routine investigations within normal limits without any other comorbidities, Patients who are not on any cardiac related drugs, Availability of written informed consent from concerned patients. |
|
| ExclusionCriteria |
| Details |
Patients not willing to give consent
patients with uncontrolled systemic disorders,
patients with peripheral vascular diseases, bleeding or coagulation disorders.
patients with local site infections and known allergies to local anaesthetics.
patients using medications like alpha and beta blockers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess peripheral perfusion index using a pulse oximeter. As an early and reliable indictaor for a successful supraclavicular block. |
To assess peripheral perfusion index as an early and reliable indictaor for a successful supraclavicular block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess if supraclavicular block is achieved at different levels at given time intervals with the perfusion index values recorded at specified time intervals using a pulse oximeter. |
2 minutes, 4 minutes, 6 minutes, 8 minutes, 10 minutes, 15 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes. |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
11/05/2026 |
| 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
|
This is a prospective observational study that investigates whether the Perfusion index (PI) can serve as an early non-invasive indicator of a successful ultrasound-guided supraclavicular block in 78 patients undergoing upper limb surgeries. The research explores PI as a physiological alternative that reflects the vasodilation caused by sympathetic blockade. By recording PI values from two-minute intervals for the first ten minutes and five minute intervals thereafter, the study aims to establish a specific PI cut-off value and ratio that accurately predicts clinical success. |