| CTRI Number |
CTRI/2024/04/066315 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Events of diaphragmatic paresis following various approach of brachial plexus block. |
|
Scientific Title of Study
|
A prospective observational study on incidences of ipsilateral hemidiaphragmatic paresis following various approach of brachial plexus block. |
| 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 Zeel Jariwala |
| Designation |
2nd Year Anaesthesia Resident |
| Affiliation |
New Civil Hospital,Surat |
| Address |
2nd floor,Department of Anaesthesia,Government Medical College, near Majura gate-Surat,Gujarat
Surat
GUJARAT
395001
India |
| Phone |
9033281811 |
| Fax |
|
| Email |
zulu4198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Kavishvar |
| Designation |
Professor and Head of Department |
| Affiliation |
New Civil Hospital,Surat |
| Address |
Department of Anaesthesiology ,Second Floor College building,New Civil Hospital,majura gate,Surat
Surat
GUJARAT
395001
India |
| Phone |
9825615264 |
| Fax |
|
| Email |
neeta_kavishvar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Kavishvar |
| Designation |
Professor and Head of Department |
| Affiliation |
New Civil Hospital,Surat |
| Address |
Department of Anaesthesiology ,Second Floor College building,New Civil Hospital,majura gate,Surat
Surat
GUJARAT
395001
India |
| Phone |
9825615264 |
| Fax |
|
| Email |
neeta_kavishvar@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| First floor operation theater,Government medical college and new civil hospital,near majura gate, surat,gujarat 395001 |
|
|
Primary Sponsor
|
| Name |
Government medical college and new civil hospital |
| Address |
New civil Hospital,majura gate Surat ,395001
Gujarat |
| 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 |
| Dr Zeel Jariwala |
New civil hospital |
First floor operation theater complex,orthopaedic Ot;New civil hospital,Majura gate,Surat,Gujarat
Surat
GUJARAT |
9033281811
zulu4198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human research and ethics Committee of GMC surat |
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 |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
patient who will undergo brachial plexus block for upper limb surgery. |
|
| ExclusionCriteria |
| Details |
1.patient not giving consent.
2.patient who are unable to perform PEFR(peak expiratory flow rate)
3.patient with diaphragmatic pathology. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidences of diaphragmatic paresis |
will record the data at two points before the brachial plexus block and 30 mintues after the block with peak flow meter and ultrasound |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| severity of diaphragmatic paresis and reduction in spo2 and peak expiratory flow rate |
will record the data at two points before the brachial plexus block and 30 mintues after the block with peak flow meter and ultrasound |
|
|
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)
|
06/05/2024 |
| 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="1"
Months="6"
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
|
being in a tertiary care hospital many trauma cases of upper limb are recorded . Most upperlimb surgeries are done under brachial plexus block as it provides anaesthsia along with postoperative analgesia with out the need of airway manipulation but phrenic nerve supplying being inclose proximity with brachial plexus gets paralysed causing ipsilateral hemidiaphragmatic pariesis. This leads to decrease in saturation and peak flow rate. Primary aim is to determine incidences of ipsilateral hemidiaphragmatic paralysis following brachail plexus block and its severity.It is measured by assessing peak flow rate and ultrasonograhic movement of diaphragm before and 30 minutes after block ,along with calculating respiratory rate and drop in saturation. |