| CTRI Number |
CTRI/2021/05/033841 [Registered on: 27/05/2021] Trial Registered Prospectively |
| Last Modified On: |
26/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
We compare the effect of Superior Trunk and Interscalene Brachial Plexus Block in proximal humerus surgery |
|
Scientific Title of Study
|
Superior Trunk vs Interscalene Brachial Plexus Block in proximal humerus surgery:A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandni Sinha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna Phulwarisharif |
| Address |
Room no-502 5th floor IPD Bulding
B Block OT Complex, AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandni Sinha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna Phulwarisharif |
| Address |
Room no-502 5th floor IPD Bulding
B Block OT Complex, AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandni Sinha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Patna Phulwarisharif |
| Address |
Room no-502 5th floor IPD Bulding
B Block OT Complex, AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,IPD Bulding, 6th floor Ot Complex ,Aiims Patna |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
Department of anaesthesiology, B Block OT Complex Aiims Patna |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS Patna |
Department of anaesthesiology, B Block OT Complex Aiims Patna |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandni Sinha |
AIIMS Patna |
Department of anaesthesia ,B Block ,OT complex AIIMS Patna
Patna
BIHAR |
7250333148
chandni.doc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Aiims Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S422||Fracture of upper end of humerus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Interscalene Brachial Plexus Block |
single dose of 15ml 0.5% bupivacaine injected perineurally between C5 and C6 nerve root |
| Intervention |
superior trunk Block |
single dose of 15ML 0.5% bupivicaine given perineurally near superior trunk |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Scheduled for upper extremity orthopedic surgery : proximal humerus
2.ASA I and II
|
|
| ExclusionCriteria |
| Details |
Known neuropathy
Pregnancy
Chronic analgesic intake
Altered coagulation parameters
Refusal
Inability to communicate
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The difference in diaphragmatic movement |
at baseline and at 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The difference in mean NRS of 24 hours in both the groups.
Total analgesic consumption in 24 hours
Time taken for the block
Any adverse effects
|
in 24 hours |
|
|
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)
|
31/05/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The conventional ultrasound-guided interscalene brachial plexus block provides excellent analgesia to proximal humerus surgery, but almost always results in phrenic nerve injury. It can also result in dorsal scapular or long thoracic nerve injury.There has been no trial till date comparing ST block with ISB in proximal humerus surgeries. we compare both the techniques in terms of analgesia and diaphragmatic function |