| CTRI Number |
CTRI/2022/11/047593 [Registered on: 23/11/2022] Trial Registered Prospectively |
| Last Modified On: |
22/11/2022 |
| 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
|
Comparing the incidence of diaphragmatic paralysis in two types of block-supraclavicular block(above the clavicle) and costoclavicular block(below the clavicle) |
|
Scientific Title of Study
|
A Randomised controlled trial of comparative study of the incidence of ipsilateral hemidiaphragmatic paresis after supraclavicular and costoclavicular brachial plexus block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEEKSHA P |
| Designation |
POST GRADUATE |
| Affiliation |
Vijayanagara institute of medical science Bellary |
| Address |
#8,4th floor, kanakadurga towers
Vidyanagar,
Bellary-583104
karnataka
India
vijayanagara institute of medical science
vijayanagara cantoment
bellary 583104
Bellary
KARNATAKA
583104
India |
| Phone |
8095122744 |
| Fax |
|
| Email |
drdeekshap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SRINIVASALU D |
| Designation |
PROFESSOR |
| Affiliation |
Vijayanagara institute of medical science Bellary |
| Address |
Department of anaesthesiology
Vijanagara Institute of Medical Science
Bellary-583104
karnataka
India
vijayanagara institute of medical science
vijayanagara cantoment
bellary 583104
Bellary
KARNATAKA
583104
India |
| Phone |
9845224880 |
| Fax |
|
| Email |
drsrinivasd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DEEKSHA P |
| Designation |
POST GRADUATE |
| Affiliation |
Vijayanagara institute of medical science Bellary |
| Address |
#8,4th floor, kanakadurga towers
Vidyanagar,
Bellary-583104
karnataka
India
vijayanagara institute of medical science
vijayanagara cantoment
bellary 583104
KARNATAKA
583104
India |
| Phone |
8095122744 |
| Fax |
|
| Email |
drdeekshap@gmail.com |
|
|
Source of Monetary or Material Support
|
| PMSSY Trauma Care Center, Ramanjaneya nagar, T.B Santorium, Bellary, Karnataka 583102 |
|
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Primary Sponsor
|
| Name |
Vijayanagar Institute of Medical Science |
| Address |
Vijayanagar Institute of Medical Science, Bellary-583104 |
| 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 |
| DEEKSHA P |
PMSSY-TCC VIMS BALLARI |
OT number 1,2,6,
1st floor,Operation theatre
Trauma care center
Near TB sanitorium
VIMS Ballari-583104
Bellary
KARNATAKA |
8095122744
drdeekshap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VIMS BELLARY |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U072||COVID 19 virus not identified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A:SUPRACLAVICULAR BLOCK
|
GROUP A-SUPRACLAVICULAR BLOCK WITH 30ml OF 0.5% ROPIVACAINE given under USG guidence by using 22G needle until the drug surrounds all the 3 cords of brachial plexus and check until the patient attains motor and sensory block every 10 minutes following which diaphragmatic paralysis is identified
FREQUENCY:1
DURATION:30 minutes |
| Intervention |
GROUP B:COSTOCLAVICULAR BLOCK |
GROUP B-COSTOCLAVICULAR BLOCK WITH 30ml OF 0.5% ROPIVACAINE given under USG guidence by using 22G needle until the drug surrounds all the 3 cords of brachial plexus and check until the patient attains motor and sensory block every 10 minutes following which diaphragmatic paralysis is identified FREQUENCY:1 DURATION:30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients of 18-60 years of age, of either sex posted for(elective/emergency) upper limb surgery.
2)ASA physical status 1,2
3)Patients with normal cardiorespiratory function. |
|
| ExclusionCriteria |
| Details |
1)Refusal by patients for the procedure.
2)Known/suspected allergy to local anaesthetics.
3)Pregnant patients
4)Patients with body mass index more than 35kg/m2
5)Patients with neuromuscular disease
6)Patients with obstructive or restrictive pulmonary disease.
7)Patients with known/suspected phrenic nerve palsy or diaphragmatic dysfunction, other medical or anatomical contraindication to brachial plexus blockade.
8)Patients with deranged coagulation profile or having bleeding diathesis.
9)Evidence of local infection at the site of block
10)Patients with family history of neural disease.
11)Patients with opiod consumptions preoperatively. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Hemidiaphragmatic paralysis by M mode ultrasound,and measuring diaphragmatic excursion and peak expiratory flow rate |
M mode ultrasound at 10 minutes interval after complete motor block and PEFR at 10 minutes interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset, duration and quality of blockade. |
At 15-30 minutes we assess sensory blockade in the Musculocutaneous(lateral forearm),radial(dorsal hand),median(thenar eminence) and ulnar(hypothenar eminence) distributions with respect to temperature, pressure and touch through Validated 3 point scale. |
|
|
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)
|
25/11/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/11/2022 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
supraclavicular brachial plexus block is one of the common technique of anaesthesia for upper limb surgeries.One of the common adverse effect of supraclavicular brachial plexus block is ipsilateral hemidiaphragmatic paresis. hfew studies have shown lower incidence of ipsilateral hemidiaphtrgamatic paresis (11.4%) following supraclavicular block,but the data is still insufficient,hence this study is planned to compare the incidence of ipsilateral hemidiphragmatic paresis between the supraclavicular and costoclavicular approach to brachial plexus block It is a prospective,double blinded,randomised control trial,which has a primary objective to compare the incidence of hemidiaphragmatic paresis after supraclavicular nd infraclavicular block and secondary objective is to see the onset and duration and quality of sensory and motor block.we are recruting sample size of 60 ,30 in each group,satisfying all the inclusion criterias.GROUP A-Supraclavicular block with 30ml of 0.5% ropivacaine and GROUP B-Costoclavicular block with 30ml of 0.5% ropivacaine. primary outcome will be measured by 1)M mode ultrasound to see the diaphragmatic excursion after 30 minutes and peak expiratory flow rate after the block post operatively |