| CTRI Number |
CTRI/2024/01/061523 [Registered on: 16/01/2024] Trial Registered Prospectively |
| Last Modified On: |
12/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of Perfusion index to detect ulnar nerve sparing in ultrasound guided supraclavicular block |
|
Scientific Title of Study
|
The Role of Perfusion Index To Detect Ulnar Nerve Sparing In Patients Undergoing
Upper Limb Surgeries Under Ultrasound Guided Supraclavicular 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 |
Aakriti Gupta |
| Designation |
Junior Resident |
| Affiliation |
Chirayu Medical College And Hospital |
| Address |
Department of Anaesthesiology
Chirayu Medical College And Hospital
Bairagarh
Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7986129296 |
| Fax |
|
| Email |
aakritigupta75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saurabh Trivedi |
| Designation |
Assistant Professor |
| Affiliation |
Chirayu Medical College And Hospital |
| Address |
Department of Anaesthesiology
Chirayu Medical College And Hospital
Bairagarh
Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7986129296 |
| Fax |
|
| Email |
drst23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aakriti Gupta |
| Designation |
Junior Resident |
| Affiliation |
Chirayu Medical College And Hospital |
| Address |
Department of Anaesthesiology
Chirayu Medical College And Hospital
Bairagarh
Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7986129296 |
| Fax |
|
| Email |
aakritigupta75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chirayu Medical College and Hospital, Bairagarh, Bhopal, 462030 |
|
|
Primary Sponsor
|
| Name |
CMCH Bhopal |
| Address |
Chirayu Medical College and Hospital, Bairagarh, Bhopal, 462030 |
| 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 Aakriti Gupta |
CMCH Bhopal |
Department of Anaesthesiology, 3rd floor, Chirayu Medical College and Hospital, Bairagarh
Bhopal
MADHYA PRADESH |
7986129296
aakritigupta75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chirayu Medical College And Hospital Institutional Human Ethics 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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Ultrasound guided Supra-clavicular block |
Perfusion index as an indicator of ulnar nerve sparing every minute for first 10min then every 3 min for the following 21min. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All adult ASA-PS I and II patients undergoing elective upper limb surgeries under USG guided supraclavicular nerve block at Chirayu Medical College and Hospital, Bhopal. |
|
| ExclusionCriteria |
| Details |
1. Emergency surgeries.
2. ASA-PS III,IV.
3. Local infection at procedure site.
4. Any coagulation disorders.
5. Any mental health issues.
6. Patients’ refusal to participate in study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of perfusion index in early detection of ulnar nerve sparing after ultrasound guided Supraclavicular block. |
Baseline, every 1minute for the first 10minutes, every 3minutes the following 21minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the earliest time at which perfusion index can reach its best predictive value. |
Baseline, every 1minute for the first 10minutes, every 3minutes the following 21minutes. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="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
|
Supraclavicular nerve block is one of the commonly performed peripheral nerve blocks for upper limb operations, however, sparing of some segments is a known complication . We aim to study the ability of perfusion index in early detection of segmental ulnar nerve sparing after ultrasound guided supraclavicular nerve block. |