| CTRI Number |
CTRI/2024/01/061071 [Registered on: 02/01/2024] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Compare the Efficacy of Ultrasound Guided Costoclavicular Block versus Supraclavicular Block for Shoulder Surgery |
|
Scientific Title of Study
|
To Compare the Efficacy of Ultrasound Guided Costoclavicular Block Versus Supraclavicular Brachial Plexus Block for Shoulder Surgery-A Randomized Double Blind Interventional Study in Department of Anaesthesiology at SMS Medical College,Jaipur. |
| 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 Vandana Mangal |
| Designation |
Senior Professor |
| Affiliation |
Sawai Mansingh Medical College,jaipur |
| Address |
Department of Anaesthesiology,Second floor,Dhanwantri Building,JLN Marg,Jaipur.
Jaipur
RAJASTHAN
302001
India |
| Phone |
9829056816 |
| Fax |
|
| Email |
vandanamangal25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Mangal |
| Designation |
Senior Professor |
| Affiliation |
Sawai Mansingh Medical College,jaipur |
| Address |
Department of Anaesthesiology,Second floor,Dhanwantri Building,JLN Marg,Jaipur.
Jaipur
RAJASTHAN
302001
India |
| Phone |
9829056816 |
| Fax |
|
| Email |
vandanamangal25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karthick S |
| Designation |
Junior Resident |
| Affiliation |
Sawai Mansingh Medical College,jaipur |
| Address |
Department of Anaesthesiology,Second floor,Dhanwantri Building,JLN Marg,Jaipur.
Jaipur
RAJASTHAN
302001
India |
| Phone |
8675907900 |
| Fax |
|
| Email |
karthickshanmugam33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,SMS Medical College,Jaipur |
|
|
Primary Sponsor
|
| Name |
Sawai Mansingh Medical College and Hospital |
| Address |
Department of Anaesthesiology,Second floor,Dhanwantri OPD Block,Jaipur. |
| 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 Vandana Mangal |
SMS Medical College and Hospital |
Department of Anaesthesiology,Second floor,Dhanwantri Building,SMS Hospital,JLN Marg,Adarsh Nagar,Jaipur.
Jaipur
RAJASTHAN |
9829056816
vandanamangal25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Comittee,SMS Medical College and attached Hospitals,Jaipur |
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 |
Group A-Patients undergoing shoulder surgery under ultrasound guided supraclavicular brachial plexus block with 20ml of 0.5% ropivacaine. |
The patient lies supine without a pillow, and the head is turned away from the side to be blocked.Following sterile preparation painting and draping done.The ultrasound probe is placed in the supraclavicular fossa in the transverse orientation parallel to the clavicle and aimed inferior toward the ipsilateral thorax. The brachial plexus and the subclavian artery are visualized.Utilizing the in-plane approach, the needle is advanced from lateral to medial, aimed for near the main neural cluster of the brachial plexus. After negative aspiration 15ml of 0.5% Ropivacaine was injected and observed. |
| Comparator Agent |
Group B-Patients undergoing shoulder surgery under ultrasound guided costoclavicular block with 20ml of 0.5% ropivacaine. |
Patient will be positioned in supine with the ipsilateral arm abducted (90 degrees) and the head turned slightly to the contralateral side. For a right-sided block, a right-handed operator will stand at the patient’s head and the ultrasound machine is placed on the contralateral side.Following sterile preparation,painting and draping done. High-frequency linear array transducer (12–15 MHz) is placed over the clavicle in the transverse orientation. Then gently it is moved caudally until it slips off the clavicle’s inferior border and the axillary artery (first part) and vein are visualized. It may be necessary to gently tilt the transducer cephalad to direct the ultrasound beam toward the Costoclavicular space. The ultrasound image is optimized until all three cords of the brachial plexus are clearly visualized lateral to the axillary artery and later 20mL of 0.5% Ropivacaine will be injected incrementally, aspirating every 5 ml. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing shoulder surgery.
2. Patients of either gender in age group of 20 to 60 years.
3. Patients of ASA grade I, II and III.
4. Patients with BMI of 18-30 kg/m2.
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate in study and uncooperative patients.
2. Coagulopathies, any neuropathy.
3. Allergy to LA (Ropivacaine).
4. Local pathology at the injection site.
5. Disability limiting the performance of block
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess and compare the nerve sparing in various dermatomes in both groups.
2.To assess and compare the nerve sparing in both groups.
3.To determine the difference in mean onset and mean duration of motor and sensory block in both groups.
|
1.Every 10 mins for 30 minutes after the block.
2.Every 10 minutes for 30 minutes after the block.
3.Every 10 minutes for 30 minutes after the block.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine the difference in mean NRS score.
2.To assess Hollmen grading of sensory block.
|
1.Every 10 minutes for 30 minutes after the block.
2.At the end of 30 minutes after the block. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/01/2024 |
| 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="0"
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
|
In this study our aim is to find out the efficacy of supraclavicular block versus costoclavicular block in shoulder surgery using 20ml of 0.5% of ropivacaine. |