| CTRI Number |
CTRI/2021/09/036994 [Registered on: 30/09/2021] Trial Registered Prospectively |
| Last Modified On: |
29/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Occurance and amount Of Hemidiaphragm Paralysis Following Ultrasound guided Supraclavicular And Interscalene Brachial Plexus Block |
|
Scientific Title of Study
|
Assessment Of Incidence and Degree of Hemidiaphragmatic Paralysis And Predictive Factors Following USG Guided Supraclavicular And Interscalene 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 |
Dr Maninder singh nehria |
| Designation |
Junior resident Department of Anesthesia |
| Affiliation |
Dr. RPGMC, kangra at Tanda |
| Address |
3 rd floor ot complex,Deptt. Of Anesthesiology, Dr. Rajendra Prasad Government Medical College Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9816195682 |
| Fax |
|
| Email |
maninder.nehria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam Bhandari |
| Designation |
Associate Professor, Department of Anesthesia |
| Affiliation |
Dr. RPGMC, kangra at Tanda |
| Address |
2nd floor Main O.T.complex, Dr. Rajendra Prasad Government Medical College Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
|
| Fax |
|
| Email |
dr.bhandari@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maninder singh nehria |
| Designation |
Junior resident Department of Anesthesia |
| Affiliation |
Dr. RPGMC, kangra at Tanda |
| Address |
3rd Floor Main O.T.complex, Dr. Rajendra Prasad Government Medical College Kangra at Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9816195682 |
| Fax |
|
| Email |
maninder.nehria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.RPGMC Tanda at Kangra
Himachal Pradesh 176001 |
|
|
Primary Sponsor
|
| Name |
Dr RPGMC KANGRA AT TANDA |
| Address |
Department of Anesthesia 3rd floor O.T.Complex Dr. RPGMC Kangra at Tanda |
| 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 Maninder singh nehria |
Dr. RPGMC Kangra at Tanda |
Dr. RPGMC kangra at Tanda 2nd floor main ot complex
Kangra
HIMACHAL PRADESH |
09816195682
maninder.nehria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.Rajendra prasad Government Medical College Kangra at Tanda Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
According to American society of Anesthesiology classification grade 1 and 2 patients |
|
| ExclusionCriteria |
| Details |
Patient having any contraindication for brachial plexus block |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe incidence and degree of hemidiaphragmatic paralysis in supraclavicular and Interscalene block |
With in one year from commencement of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the onset and degree of hemidiaphragmatic paralysis |
2yrs |
| Relation with dose, volume and concentration of drug used |
2yrs |
| Correlatio with oxygen saturation and dyspnea |
2yrs |
| Relation with BMI if any |
2yrs |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/10/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Assessment of incidence and degree of hemidiaphragmatic paralysis and predictive factors following USG guided supraclavicular and Interscalene brachial plexus block in patients posted for upper limb surgery |