| CTRI Number |
CTRI/2024/12/078668 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Correlation of Perfusion Index (PI) and PI Ratio with the Success of Ultrasound-Guided Supraclavicular Block |
|
Scientific Title of Study
|
A study to correlate values of perfusion index(PI) and PI ratio with success of 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 |
Dr Ramesh Kumar |
| Designation |
Professor , Department of Anesthesia , IGMC Shimla |
| Affiliation |
IGMC , Shimla |
| Address |
Department of Anaesthesiology,Indira Gandhi Medical College , Ridge - Sanjouli Road , Lakkar Bazar, Shimla , H.P , 171001, India
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418077428 |
| Fax |
|
| Email |
drrameshkumar66@gmail.com1 |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Kumar |
| Designation |
Professor , Department of Anesthesia , IGMC Shimla |
| Affiliation |
IGMC , Shimla |
| Address |
Department of Anaesthesiology,Indira Gandhi Medical College , Ridge - Sanjouli Road , Lakkar Bazar, Shimla , H.P , 171001, India
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418077428 |
| Fax |
|
| Email |
drrameshkumar66@gmail.com1 |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shavi Singla |
| Designation |
Junior Resident |
| Affiliation |
IGMC , SHIMLA |
| Address |
Department of Anaesthesiology,Indira Gandhi Medical College , Ridge - Sanjouli Road , Lakkar Bazar, Shimla , H.P , 171001, India
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9876616158 |
| Fax |
|
| Email |
shavisingla11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Available in Indira Gandhi medical college , Shimla |
| Himachal Pradesh Government |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College |
| Address |
Ridge , Sanjauli Road, Lakkar Bazar, Shimla, Himachal Pradesh-171001 |
| Type of Sponsor |
Government 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 Shavi Singla |
Indira Gandhi Medical College , Shimla , Himachal Pradesh , India |
Department of Anesthesia , IGMC , RIDGE SANJOULI ROAD , LAKKAR BAZAR,171001.
Shimla
HIMACHAL PRADESH |
9876616158
shavisingla11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira Gandhi Medical College , Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V988||Other specified transport accidents, (2) ICD-10 Condition: V229||Unspecified motorcycle rider injured in collision with two- or three-wheeled motor vehicle in traffic accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General anesthesia |
General anesthesia is given in the patients contraindicated for the supraclavicular block |
| Intervention |
Ultrasound guided Supraclavicular Block |
Supraclavicular Block is given for the upper limb surgeries under USG guidance . Drugs to be given injection bupivacaine 0.25% with injection lignocaine with ADR 0.1% , total 30cc . Observation period is 30 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I & II patients.
Patient undergoing upper extremity orthopedic surgery.
Both male and female patient in the age group of 18-60 years. |
|
| ExclusionCriteria |
| Details |
I. Patient refusal for regional anaesthesia or unwillingness to participate in
study.
II. H/O allergy to local anaesthetics.
III. Local site infection.
IV. Patient with peripheral vascular disease.
V. H/O coagulation disorders.
VI. Use of medication like alpha and beta blockers.
VII. H/o anticoagulation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A study to correlate values of PI and PI ratio with success and/or
failure of ultrasound guided supraclavicular block. |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. To calculate the cut off value of perfusion index for
successful supraclavicular block, if any.
ii. To compare the perfusion index between blocked and
unblocked arm. |
30 minutes |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2025 |
| 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="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
|
An
increase in PI is an early indicator that a general, epidural and regional block
has initiated peripheral vasodilation which typically occurs after the onset of
anaesthetic effect only. A few studies are there in literature about the actual
value of PI in a successful SCB. Therefore we decided to carry out the study to
know the cut off value of PI for USG guided successful SCB using lignocaine
with adrenaline 2% and bupivacaine 0.5% total volume 30 ml in 1:1 ratio. |