| CTRI Number |
CTRI/2024/09/074293 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Hemidiaphragmetic paralysis in supraclavicular and infraclavicular brachial plexus block |
|
Scientific Title of Study
|
Comparison of Hemidiaphragmetic paralysis in supraclavicular vs Infraclavicular brachial plexus block in adult patients undergoing elective brachial vein transposition |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shresta km |
| Designation |
Md Anesthesia (junior resident) |
| Affiliation |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
JSS Hospital, Mahatma Gandhi road, Fort moholla, Mysore
Department of Anaesthesiology, JSS Hospital.
Ot complex, Third floor
Mysore
KARNATAKA
570004
India |
| Phone |
8147246123 |
| Fax |
|
| Email |
shrestakm31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
JSSAHER |
| Address |
JSS Hospital , Mahatma gandhi road, Fort mohalla , Mysore
Department of Anaesthesiology
JSS Hospital, Third floor ot complex ,Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9663237722 |
| Fax |
|
| Email |
drdinu80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
JSSAHER |
| Address |
JSS Hospital , Mahatma gandhi road, fort mohalla, Mysore
Department of Anaesthesiology Third floor ot complex
JSS Hospital, Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9663237722 |
| Fax |
|
| Email |
drdinu80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jss Accademy Of Higher Education and Research, Bannimantap, Mysuru, Karnataka,India , 570004 |
|
|
Primary Sponsor
|
| Name |
JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
Jss Medical Collage And Hospital Bannimantap, Mysuru, Karnataka,India, 570004 |
| 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 SHRESTA KM |
Jss Medical College And Hospital |
Department of Anaesthesiology,
Third floor ot Complex, Mg road , Agrahara , Mysore, Karnataka
Mysore
KARNATAKA |
8147246123
shrestakm31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSSAHER institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I826||Acute embolism and thrombosis of veins of upper extremity, (2) ICD-10 Condition: I872||Venous insufficiency (chronic) (peripheral), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Supraclvicular vs Infraclavicular brachial plexus block |
The interventional arm will be anaesthetized. The sensory and motor blockade will be compared with un anaesthetized arm i.e. comparator arm Patients in the age group of 20-60 0f either sex undergoing elective upper limb vascular under brachial plexus block will be enrolled for the study with written informed consent. Prior to 30 minutes of surgery sonographic assessment of diaphragm motion and contraction will be done using “ABCDE “ method . The patient will be connected to standard monitors such as NIBP , [ECG] and pulse of oximetry[Sp02].All blocks will be performed under ultrasound guidance (Logiq p6 pro ultrasound system manufactured by GE healthcare) using linear probe of frequency 15-20 hz (11L) at different locations . Each patient will be administered mixture of 22 ml, out of which 10 ml is 0.5% Bupivacaine , 10ml is 2% lignocaine with adrenaline. , Dexamethasone 4mg (1ml) and clonidine 150mcg. . Adequacy of sensory and motor blockade will be assessed .After about 30 minutes of observation the movement of Diaphragm will be assessed using Ultrasonography by using the ‘ABCDE teqnique.In group SC, patients will be placed in a supine position, and the head turned slightly to the contralateral side. A transverse scan will be performed immediately above the clavicle. The transducer will be gently tilted caudad to direct the ultrasound beam towards the first rib. The first target will be the corner pocket (i.e., the intersection between the first rib and the subclavian artery). Subsequently, the needle will be repositioned under direct vision and directed towards the neural cluster formed by the trunks and divisions of the brachial plexus. 5 to 10 ml of local anesthetic will be injected into the corner pocket [i.e intersection between the first rib and the subclavian artery}, followed by an injection of 15–20 ml between each trunk or division via Stimpulex 22G needle. Costoclavicular Block
In group c patients will be placed in a supine position with the surgical limb abducted at an angle of 90 degrees. A transverse scan will be performed immediately below the midpoint of the clavicle and over the medial infraclavicular fossa. Maintaining the same position, the transducer will be gently tilted cephalad to direct the ultrasound beam towards the costoclavicular space, defined as the space between the posterior surface of the clavicle and the second rib. The ultrasound image is optimised until all three cords of the brachial plexus are visualized lateral to the axillary artery. Using an in-plane technique and a lateral to-medial direction, the block needle is advanced until its tip is located in the middle of the three cords. Initially, 15–20 mL of local anesthetic is injected between the medial and posterior cord. The needle is then slightly withdrawn and its tip was relocated adjacent to the lateral cord, and an additional 5–10 mL of anesthetic is injected. .
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 20 to 60 years undergoing elective basilic vein transposition under brachial plexus block |
|
| ExclusionCriteria |
| Details |
1) Patient refusal
2) Hypersensitivity to amide anesthetic
3) Pre-existing neuropathy to surgical limb
4) significant pulmonary disease
5)coagulopathy
6) infection at block site |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Hemidiaphragmetic palsy in supraclavicular vs infraclavicular brachial plexus block |
From the time of brachial plexus block to 4 hours later |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adequacy of sensory, Motor blockade, Patient satisfaction, pulmonary complications |
From the time of brachial plexus block to 4 hours later |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/10/2024 |
| 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="1"
Days="6" |
|
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
|
Following approval from the Institutional Ethical committee, Patients will be evaluated for the eligibility of the study , and written informed consents will be obtained from enrolled participants by the study team before surgery . A thorough pre anesthetic evaluation will be done 24 hrs prior to the procedure. Patients will be randomly assigned using shuffled sealed ,opaque enveloped technique at ratio of 1:1into two groups . GROUP (SC)- Supraclavicular brachial plexus block GROUP(CC)- Costoclavicular block ANESTHETIC PROCEDURES Patients in the age group of 20-60 of either sex undergoing elective basilic vein transposition under brachial plexus block will be enrolled for the study with written informed consent On the day of surgery, a single anesthesiologist performs either the supraclavicular or infraclavicular block. Prior to 30 minutes of surgery sonographic assessment of diaphragm motion and contraction will be done using “ABCDE “ method described by Tsui et all(2).Which is performed by placing the probe at zone of apposition of anterior Axillary line, watching for breathing (lung sliding), then moving caudally to identify the diaphragm for evaluation . An 20 G iv cannula will be inserted and the patient is connected to standard monitors such as noninvasive blood pressure , electrocardiography [ECG] and pulse oximetry[Sp02]. All blocks will be performed under ultrasound guidance (Logiq p6 pro ultrasound system manufactured by GE healthcare) by a single experienced Anesthesiologist using linear probe of frequency 15-20 hz (11L) at different locations . Each patient will be administered mixture of 22 ml, out of which 10 ml is 0.5% Bupivacaine , 10ml is 2% lignocaine with adrenaline. , Dexamethasone 4mg (1ml) and clonidine 150mcg. . Adequacy of sensory and motor blockade will be assessed .After about 30 minutes of observation the movement of Diaphragm will be assessed using Ultrasonography by using the ‘ABCDE teqnique. Patient satisfaction and complications like vascular puncture and pneumothorax will be assessed.
|