| CTRI Number |
CTRI/2025/05/087855 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Diaphragmatic Weakness In Extrafascial and Inrtafascial Interscalene Brachial Plexus Block |
|
Scientific Title of Study
|
Impact Of Interscalene Brachial Plexus Block Causing Hemidiphragmatic Paresis in Extrafascial And Intrafascial Injections : A Prospective Double Blind Randomized Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrKeerthana |
| Designation |
Resident doctor in Department of Anaesthesia |
| Affiliation |
Government medical college, Baroda |
| Address |
Room No 56,New RMO hostel ,jail road ,Anandpura, Government Medical College , Baroda Vadodara, Gujarat
Room No 56,New RMO hostel ,jail road ,Anandpura, Government Medical College , Baroda Vadodara, Gujarat
Vadodara
GUJARAT
390001
India |
| Phone |
8610038510 |
| Fax |
|
| Email |
keerthana.rk2023@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Shah |
| Designation |
Associate Professor in Department of Anaesthesia |
| Affiliation |
Government medical college, Baroda |
| Address |
2nd Floor ,New Surgical BLock Department of Anaesthesiology,Government Medical College , Baroda Vadodara, Gujarat
2nd Floor ,New Surgical BLock Department of Anaesthesiology,Government Medical College , Baroda Vadodara, Gujarat
Vadodara
GUJARAT
390001
India |
| Phone |
8610038510 |
| Fax |
|
| Email |
nehakinitshah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Shah |
| Designation |
Associate Professor in Department of Anaesthesia |
| Affiliation |
Government medical college, Baroda |
| Address |
2nd Floor ,New Surgical BLock Department of Anaesthesiology,Government Medical College , Baroda Vadodara, Gujarat
2nd Floor ,New Surgical BLock Department of Anaesthesiology,Government Medical College , Baroda Vadodara, Gujarat
Vadodara
GUJARAT
390001
India |
| Phone |
8610038510 |
| Fax |
|
| Email |
nehakinitshah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, SSG hospital Vadodara 390001, Gujarat,India |
|
|
Primary Sponsor
|
| Name |
Government Medical college,Baroda |
| Address |
Department of Anesthesiology, New surgical block, SSG hospital Vadodara 390001, Gujarat, India |
| 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 |
| DrKeerthana |
SSG Hospital Vadodara |
Trauma Operation theatre,, first floor, New surgical block, Government Medical College, Vadodara
Vadodara
GUJARAT |
8610038510
keerthana.rk2023@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for Biomedical and health research,government medical college baroda |
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 |
Extrafascial interscalene Block |
A 22 G Needle is inserted under ultrasound guidance connected to a peripheral nerve stimulator along the brachial plexus sheath identified as hyperechoic layer surrounding the C6,C7,C8 roots and transducer is manipulated as necessary to bring the needle into the imaging axis of the transducer through the middle scalene muscle towards the brachial plane. (The brachial plexus usually appears as the ‘The stop light sign’, made up of three root structures C5,C6,C7). Thereafter, needle should be slowly advanced towards the lateral border of brachial plexus sheath .The final needle tip position will be lateral to the brachial plexus sheath . The on-screen calliper measurement tool will be used to define this distance of 3-4 mm, with the proximal calliper placed on the lateral border of the plexus sheath and the distal calliper extended laterally until the designated distance is reached, marking the target end point for the needle tip position and drug is injected extrafascially. |
| Comparator Agent |
Intrafascial Interscalene Nerve block |
The needle should be slowly advanced till it pierce brachial plexus sheath. The final needle tip position will be within the brachial plexus sheath in between the C5 and C6 nerve roots and drug is injected intrafascially |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient posted for mid shaft and distal humerus surgeries
Age Group in the range of 18 to 65 years of either sex.
Weight in the range of 45 to 70 kilogram.
ASA grade 1 and 2
Duration of Surgery Less than 3 hours.
Patient able to give written and informed consent.
|
|
| ExclusionCriteria |
| Details |
Patient not willing for procedure.
Existing neurological deficit in the upper limb, history of neck surgery or radiotherapy severe pulmonary disease, chest deformity, Contraindications to peripheral nerve block(allergy to local anaesthetics, coagulopathy, infection in the area), and pregnancy.
Patients with significant history of drug or alcohol abuse, psychiatric illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the Hemidiaphragmatic paresis by measuring the percentage of reduction in diaphragmatic excursion with the help of M-mode ultrasonography. |
Before and 30 minutes after the interscalene block in all patients. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To be observed for difference in
Peak expiratory flow rate
FEV1 ( Forced expiratory volume in 1 sec)
Measured by digital spirometer-peak flow meter device before and 30 minutes
after giving block.
To be observed for change in Respiratory rate and SpO2 perioperatively by pulse oximeter.
Sensory block will be assessed by observing time to achieve complete sensory effect and its duration.
Motor block will be assessed by observing time to achieve complete motor effect and its duration.
To be observed for block efficacy (success rate) in terms of additional anaesthsia requirement during surgery (such as IV Fentanyl 1-2mcg/kg , local infiltration, Inj. Ketofol 1:1 ) .
Perioperatively haemodynamic parameters will be observed ( pulse rate, mean arterial pressure).
Complications if any will be observed perioperatively for 24 hrs. |
After standard instructions, the patient in a sitting
upright position will be asked to inspire maximally and blow into the device as fast and strong as possible. The test will be repeated three times and the best value will be recorded with a bedside peakflow meter
before procedure and 30 minutes after procedure.
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/09/2025 |
| 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 Yet Recruiting |
| 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
|
The aim of study is to compare Extrafascial and intrafascial injections using interscalene approach of brachial plexus block causing hemidiphragmatic paresis in midshaft and distal humerus surgeries.in Group E , patients will be given interscalene nerve block via Extrafascial injection under USG guidance.in Group I, patients will be given interscalene nerve block via Intrafascial injection under USG guidance.Total 15ml volume of drug solution will be prepared with 0-5% bupivacaine 15 ml with 5 microgram of Adrenaline (1:200000)The primary outcome is to compare hemidiaphragmatic paresis with M-mode ultrasonography befor / 30 minuts after the interscalere block.Secondary outcome, difference in Peak expiratony flow rate, Forced expiratory Volume in /sec, change in respiratory rate., assesment of sensory block in terms of time to achieve complete effect and duration, and requirement of additional anaesthesia in terms of IV Fentanyl, local infiltration, IV Ketamine and propofol will be observed for satisfactory anaesthesia. Success rate will be calculated accordingly. Hemodynamic parameters such as pulse, mean arterial pressure, SPo2, ECG. perioperative complications. |