| CTRI Number |
CTRI/2022/02/040329 [Registered on: 15/02/2022] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Sonography of Corner Pocket area in Supra clavicular Block and Its Clini-cal Implications |
|
Scientific Title of Study
|
Perception of Vascular Structures at The Corner Pocket in Supra clavicular Block and Its Clini-cal Implications |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avinash Gaikwad |
| Designation |
Anaesthesiologist |
| Affiliation |
Sancheti Institute for orthopaedics and rehabilitation |
| Address |
G -303, trillium,magarpatta city,hadapsar, pune
shivaji nagar,Pune-411005
Pune
MAHARASHTRA
411013
India |
| Phone |
8007778750 |
| Fax |
|
| Email |
avipune22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Avinash Gaikwad |
| Designation |
Anaesthesiologist |
| Affiliation |
Sancheti Institute for orthopaedics and rehabilitation |
| Address |
Anaesthesia department, first floor, OT complex,Sancheti hospital, shivaji nagar, PUNE
shivaji nagar,Pune-411005
Pune
MAHARASHTRA
411013
India |
| Phone |
8007778750 |
| Fax |
|
| Email |
avipune22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Avinash Gaikwad |
| Designation |
Anaesthesiologist |
| Affiliation |
Sancheti Institute for orthopaedics and rehabilitation |
| Address |
G-303, Trillium, Magarpatta city,Pune
shivaji nagar,Pune-411005
Pune
MAHARASHTRA
411013
India |
| Phone |
8007778750 |
| Fax |
|
| Email |
avipune22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti institute for orthopaedics and rehabilitation |
|
|
Primary Sponsor
|
| Name |
Sancheti institute for orthopaedics and rehabilitation |
| Address |
shivaji nagar, Pune -411005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Avinash Gaikwad |
Sancheti institute for orthopaedics and rehabilitation |
Anaesthesia department,shivaji nagar, Pune -411005
Pune
MAHARASHTRA |
8007778750
avipune22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Sancheti institute for orthopaedics and rehabilitation,shivaji nagar, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M219||Unspecified acquired deformity oflimb and hand, (2) ICD-10 Condition: S599||Unspecified injury of elbow and forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Perception Of Vascular Structures at The Corner Pocket in Supraclavicular Block and Its Clinical Implications |
Materials and Methods
Patient planned for upper limb surgery below the level of elbow
Equipment
Portable Ultrasonography (USG) machine with 5-13MHz linear probe
Peripheral Nerve Stimulator
PNS Needle- 22G 5cm ultra 360 needle, Multipara vitals monitor
Technique
Block Procedure will be performed in operating room. Patient will be monitored with a multipa-ra monitor and intravenous access will be obtained with a 22g canula. A Dual guidance (USG + PNS) method is used to perform brachial plexus block. In the supine position the arm is adducted and a scout scan of ipsilateral supraclavicular area is performed to visualize the neural target and abnormal vasculature if any, in the corner pocket.
Corner pocket is a recess between Subclavian artery anteriorly & first rib posteriorly. The USG transducer probe is placed behind the mid-point of the clavicle in the supraclavicular area with orientation marker directed medially.
Corner pocket area is scanned for presence of any vessel using colour doppler mode.
If any vessel is visualized, then multiple images are saved and videos are recorded and supra-clavicular block is cancelled & alternative block ( Costoclavicular, Infraclavicular, Axillary) is performed.
duration of usg scanning will be 3 to 5min
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA status I to II
|
|
| ExclusionCriteria |
| Details |
Patients with previous surgery of ipsilateral clavicle, COPD, Contralateral Phrenic nerve palsy
History suggestive of local anesthetic allergy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| - To find the prevalence of vasculature in the vicinity of the corner pocket |
1 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To understand the pattern and position of the aberrant vessels, incidence of conversion of US-SCB to other approaches |
1 min |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/02/2022 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
Nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
USG guided Supraclavicular block is a preferred method of regional anaesthesia for upper limb surgery below level of shoulder. Corner pocket is a recess between Subclavian artery, brachial plexus and first rib. It contains lower trunk of brachial plexus. Vascular anatomy of corner pocket recess has remained unsearched. with the help of USG machine we aim to explore the presence of aberrant vasculaturein corner pocket area, which could possess contraindication to supraclavicular block |