| CTRI Number |
CTRI/2024/10/075332 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Ultrasound guided Supraclavicular Brachial plexus block effectiveness will be seen using pulse oximeter derived perfusion index |
|
Scientific Title of Study
|
To evaluate the success of ultrasonographic supraclavicular brachial plexus block using pulse oximetry derived perfusion index |
| Trial Acronym |
Brachial Plexus Block |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jasmeen Mahajan |
| Designation |
Post Graduate student |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Department of anaesthesia, third floor ,Maharishi Markandeshwar Medical College and Hospital,
Kumarhatti, solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7307800063 |
| Fax |
|
| Email |
drjasmeenmahajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin K Gupta |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Room no 604, third floor ,Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
9877484849 |
| Fax |
|
| Email |
sachinkg78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jasmeen Mahajan |
| Designation |
Post Graduate student |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan |
| Address |
Department of Anaesthesia , third floor ,Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7307800063 |
| Fax |
|
| Email |
drjasmeenmahajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Medical College and Hospital, Kumarhatti-Solan ,India ,Pincode - 173229 |
|
|
Primary Sponsor
|
| Name |
Dr Jasmeen Mahajan |
| Address |
Department of Anaesthesia, Maharishi Markandeshwar Medical College and Hospital, Kumarhatti-Solan , India , Pincode- 173229 |
| 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 Jasmeen Mahajan |
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti-Solan |
O.T. Complex,Third Floor
Solan
HIMACHAL PRADESH |
7307800063
drjasmeenmahajan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan |
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 |
Patients undergoing upper limb surgeries involving distal humerus and below under US guided supraclavicular block
Patients in 18-60 age group and of either sex
Patients with ASA I and II |
|
| ExclusionCriteria |
| Details |
Injection site local infection
Patients on anticoagulants
Bleeding conditions
History of Diabetes Mellitus to rule out diabetic neuropathy
History of local anaesthetic allergy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analyse the variations of perfusion index after supraclavicular block |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the minimum value of perfusion index necessary for a successful supraclavicular block |
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
22/10/2024 |
| 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="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
|
Evaluation of the success of ultrasound guided supraclavicular brachial plexus block using pulse oximetry derived perfusion index and determining the minimum value of perfusion index necessary for a successful supraclavicular block. |