| CTRI Number |
CTRI/2024/04/065028 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare local injection given below collar bone and above collar bone approach using ultrasound for upper limb fractures |
|
Scientific Title of Study
|
A prospective comparative study of ultrasound guided paravascular supraclavicular brachial plexus block and costoclavicular approach to infraclavicular brachial plexus block 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 Nandini CV |
| Designation |
Associate professor |
| Affiliation |
Dr B R Ambedkar Medical college and hospital |
| Address |
Department of Anesthesiology
Dr B R Ambedkar medical college and hospital
Kg halli
Bengaluru -560045
Bangalore KARNATAKA 560045 India |
| Phone |
9535024072 |
| Fax |
|
| Email |
nandinivraj@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nandini CV |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar Medical college and Hospital |
| Address |
Dr B R Ambedkar Medical college and Hospital
KG halli
Bengaluru-560045
Bangalore KARNATAKA 560045 India |
| Phone |
9535024072 |
| Fax |
|
| Email |
nandinivraj@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Nandini CV |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar Medical College and Hospital |
| Address |
Dr B R Ambedkar Medical College and Hospital
KG Halli
Bengaluru-560045
Bangalore KARNATAKA 560045 India |
| Phone |
9535024072 |
| Fax |
|
| Email |
nandinivraj@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar Medical College and Hospital
kg halli
Bengaluru
India 560045 |
|
|
Primary Sponsor
|
| Name |
Dr Nandini CV |
| Address |
Department of Anesthesiology
Dr B R Ambedkar Medical College and Hospital
Bengaluru 560045
India
|
| 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 Nandini CV |
Dr B R Ambedkar Medical college and hsopital |
Department of Anaestheiology
Dr B R Ambedkar Medical College And Hospital
KG Halli
Bengaluru 560045
India Bangalore KARNATAKA |
9535024072
nandinivraj@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics committee Dr. B.R.Ambedkar Medical college and Hospital |
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 |
costoclavicular approach to infraclavicular block |
ultrasound guided infraclavicular block is given with local anesthetic injection bupivacaine 0.5% 25-30ml |
| Comparator Agent |
Para vascular supraclavicular block |
ultrasound guided supraclavicular block is given with local anesthetic injection bupivacaine 0.5% 25-30ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.patients aged 18-65 years
2.patients belonging to American society of anesthesiologist grade 1 and 2
|
|
| ExclusionCriteria |
| Details |
1)known drug allergy to local anaesthetics.
2)patients with any coagulation disorder
3)procedure site infection
4)patients with mental health issues.
5) patients with pulmonary pathology and chest deformity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the time taken for onset of sensory blockade of ultrasound guided Para- vascular supraclavicular approach and costoclavicular approach to infraclavicular brachial plexus block for surgical anaesthesia of upper limb. |
From the time of block till the sensory blockade |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the time taken to perform ultrasound guided Para vascular supraclavicular approach & costoclavicular infraclavicular approach to brachial plexus block
2.To study the time taken for onset of motor blockade
3. To know any adverse effects
4.Duration of analgesia
5.Requirement of rescue analgesia for 24 hrs.
|
From the time of block upto 24 hours after the block
|
|
|
Target Sample Size
|
Total Sample Size="35" Sample Size from India="35"
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)
|
05/04/2024 |
| 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="0" 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 anesthetic technique has very much to offer to anesthesiologist, surgeon, as well as patients owing to its advantages over general anesthesia 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 anesthetic make ultrasound guided regional anesthesia highly appealing. Infraclavicular brachial plexus block and supraclavicular brachial plexus block provides anaesthesia for arm, forearm and elbow. Although both supraclavicular and infraclavicular blocks can be utilized for upper limb surgeries, anesthesiologists often have a tendency for supraclavicular over infraclavicular block because of the technical difficulty and increased complications with the blind approach in the latter. The advent of ultrasonography in anesthesia practice has made it a valuable adjunct in peripheral nerve blocks. Many studies have compared supraclavicular and infraclavicular brachial plexus block but study comparing the ultrasound guided paravascular approach of supraclavicular and costo clavicular approach to infraclavicular brachial plexus block are relatively few. Most of the studies have utilized the corner pocket approach for supraclavicular and lateral parasagittal approach for infraclavicular brachial plexus block. In paravascular approach to brachial plexus block local anesthestic is injected at a single site and hence doesnot require needle repositing. Similarly costo clavicular approach to infraclavicular brachial plexus block requires single site injection of local anaesthetic until complete blockade is achieved. The aim is to study para-vascular supraclavicular approach and costo-clavicular approach to infraclavicular brachial plexus block using ultrasound. | |