| CTRI Number |
CTRI/2023/09/057812 [Registered on: 18/09/2023] Trial Registered Prospectively |
| Last Modified On: |
13/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An injection given below collar bone to numb the arm using ultrasound scan for upper arm fractures |
|
Scientific Title of Study
|
An observational study of ultrasound guided infraclavicular block of brachial plexus in patients undergoing 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 Harshini Sankala R |
| Designation |
Postgraduate resident |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
Ot complex
Department of anaesthesiology
Dr B R Ambedkar medical college and hospital
Kg halli
KARNATAKA
560045
INDIA
Bangalore
KARNATAKA
560045
India |
| Phone |
8978926472 |
| Fax |
|
| Email |
harshini.sankala7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Santosh kumar |
| Designation |
Professor |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
Dr B R Ambedkar medical college and hospital
Kg halli
Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
9845785715 |
| Fax |
|
| Email |
drsantoshkumarcc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshini sankala R |
| Designation |
Postgraduate resident |
| Affiliation |
Dr B R Amedkar medical college and hospital |
| Address |
Department of anaesthesiology
B R Ambedkar medical and hospital
Kg halli
Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
8978926472 |
| Fax |
|
| Email |
harshini.sankala7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar medical college and hospital
Bengaluru |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Harshini Sankala R |
O T COMPLEX |
Dr B R Ambedkar Medical College and Hospital
K G Halli,
Bengaluru 560045
KARNATAKA
Bangalore
KARNATAKA |
8978926472
harshini.sankala7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION 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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. patients undergoing between 18 to 65 years of age posted for elective upper limb surgeries
2.american society of anaesthesiologist physical status class 1 and 2 |
|
| ExclusionCriteria |
| Details |
known allergy to any drug used |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the onset of sensory blockade of ultrasound guided infraclavicular block of brachial plexus |
To know the onset of sensory blockade of ultrasound guided infraclavicular block of brachial plexus |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time taken to perform the block
2.To know the onset of motor blockade
3.To know any adverse effects & requirement of rescue analgesia |
To know the time taken to perform the block.
From the time of block till the onset of motor blockade.
From the time of the block till the time request of 1st dose of rescue analgesia |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/09/2023 |
| 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
|
A well conducted regional anaesthetic technique has very much to offer to anaesthesiologist as well as patients owing to its advantages over general anaesthesia such as remaining conscious avoiding polypharmacy better hemodynamic stability and excellent post operative analgesia. the introduction of ultrasonography has revived the interest in peripheral nerve blocks. the inherent benefits of direct visualization of nerves and surrounding anatomy continual observation of needle tip and spread of local anaesthetic make ultrasound guided regional anaesthesia highly appealing. infraclavicular brachial plexus block provide anaesthesia for hand forearm elbow and distal humerus. both the axillary and musculocutaneous nerves are blocked at the level of cords before they branch from brachial plexus sheath. in cintrast to interscalene and supraclavicular bloackade an infraclavicular block has minimal risk to intervertebral itrathecal or epidural injection as well as reduced incidence of phrenic nerve paralysis or stellate ganglion block.infraclavicular approach has lesser risk of penumothorax hemotoma and nerve injury. infraclavicular approach is a single pass technique making it more feasible. the main aim is to study the efficacy of infraclavicular block of brachial plexus using ultrasound. |