| CTRI Number |
CTRI/2023/08/056039 [Registered on: 02/08/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to evaluate better approach in between supraclavicular and infraclavicular approaches to brachial plexus block with the help of USG guided nerve stimulation in upper limb surgeries, in terms of block performance time, onset time of sensory and motor block and time to readiness for surgery. |
|
Scientific Title of Study
|
A prospective randomized interventional study comparing block performance time in supraclavicular & infraclavicular approaches to brachial plexus block using both ultrasound & nerve stimulator in department of anaesthesiology and critical care 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 Shashi Kanwar Khangarot |
| Designation |
Resident Doctor |
| Affiliation |
Sawai Man Singh medical college and hospital |
| Address |
Department of Anaesthesiology, Sawai Man Singh medical college and hospital, Adarsh nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9799957144 |
| Fax |
|
| Email |
shashi.khangarot@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitra Singh |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh medical college and hospital |
| Address |
Department of Anaesthesiology, Sawai Man Singh medical college and hospital, Adarsh nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9166609479 |
| Fax |
|
| Email |
raghuvanshichitra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chitra Singh |
| Designation |
Associate Professor |
| Affiliation |
Sawai Man Singh medical college and hospital |
| Address |
Department of Anaesthesiology, Sawai Man Singh medical college and hospital, Adarsh nagar, Jaipur
RAJASTHAN
302004
India |
| Phone |
9166609479 |
| Fax |
|
| Email |
raghuvanshichitra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sawai Man Singh medical college and hospital, Adarsh nagar, Jaipur 302004 |
|
|
Primary Sponsor
|
| Name |
Dr Shashi Kanwar Khangarot |
| Address |
Department of Anaesthesiology, Sawai Man Singh medical college and hospital, Adarsh nagar, Jaipur 302004 |
| Type of Sponsor |
Other [self] |
|
|
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 Shashi Kanwar Khangarot |
Sawai Man Singh medical college and hospital. |
Department of Anaesthesiology and critical care
Jaipur
RAJASTHAN |
9799957144
shashi.khangarot@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.M.S Medical college and attached hospital institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S699||Unspecified injury of wrist, handand finger(s), (2) ICD-10 Condition: S599||Unspecified injury of elbow and forearm, (3) ICD-10 Condition: S499||Unspecified injury of shoulder andupper arm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Infraclavicular brachial plexus block |
The transducer to be placed in the parasagittal plane just medial to coracoid process and inferior to the clavicle and view is optimized till axillary artery and 3 cords of brachial plexus visualized. The needle to be inserted in plane from the cephalic aspect and aimed towards the posterior part of the axillary artery. Neurostimulation to be used concurrently at 1mA and posterior cord motor response of the finger and hand extensions to be elicited. Intensity lowered to 0.5mA at lowest response to be elicited and 20 ml of 0.5% bupivacaine injected under USG visualization to achieve U shaped spread around artery. |
| Intervention |
Supraclavicular brachial plexus block |
The transducer of USG machine to be positioned in the transverse plane just superior to clavicle at its midpoint to obtain a optimized view of subclavian artery, pleura and first rib along with brachial plexus. The objective is to place the 20 G needle in the brachial plexus sheath and inject 20 ml of 0.5% bupivacaine to visualize the spread within the plexus and centrifugal displacement of the trunks and divisions. As the needle enter the brachial plexus sheath a current intensity of 1mA to be given using the peripheral nerve stimulator . Motor response to be elicited to confirm needle placement and intensity lowered to 0.5 mA at which lowest twitch response to be elicited and after confirmation of placement of needle 20 ml of 0.5% bupivacaine injected in two places. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing to participate. 2.Cooperative patients and ASA grade 1 to 3. 3.BMI 18-30 kg/m2. 4.Patients undergoing elective surgical procedure on upper limb of duration 1-4 hours. |
|
| ExclusionCriteria |
| Details |
1.Coagulopathies and any neuropathies. 2.Allergic to bupivacaine. 3.Local pathology at the site of injection site. 4.Any disability limiting the performance of block. 5.Patients with chest deformity , clavicle fractures and pregnancy. |
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess block performance time |
1 min to 20 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time of onset of sensory & motor block |
3 min to 30 min |
| Time of readiness of surgery |
3 min to 30 min |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
07/08/2023 |
| 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="0"
Months="8"
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
|
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Brief Summary
|
This study is a randomized, single blind, parallel group, single center trial comparing supraclavicular and infraclavicular approaches of brachial plexus block in 80 patients who will undergo upper limb surgeries . The primary outcome will measure block performance time in both approaches and secondary outcomes will measure onset time of sensory and motor block, and time of readiness of surgery. |