| CTRI Number |
CTRI/2023/10/058697 [Registered on: 16/10/2023] Trial Registered Prospectively |
| Last Modified On: |
05/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO See occurrence of diaphragmatic paralysis in patients after recieving Supraclavicular v/s Costoclavicular brachial plexus block in upper limb surgeries |
|
Scientific Title of Study
|
Occurrence of Hemidiaphragmatic Paralysis in Patients Receiving Ultrasound guided Costoclavicular v/s Supraclavicular Block in Upper limb Surgeries: A Randomized Double Blind Interventional study,SMS hospital Jaipur |
| 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 Vandana mangal |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of anesthesia Dhanwantri building, SMS medical college,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829056816 |
| Fax |
|
| Email |
vandanamangal25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana mangal |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of anesthesia Dhanwantri building, SMS medical college,Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829056816 |
| Fax |
|
| Email |
vandanamangal25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabhu |
| Designation |
PG student |
| Affiliation |
SMS Medical college |
| Address |
Department of anaesthesia, second floor, Dhanvantri complex
SMS Hospital, Jaipur
Department of anaesthesia, second floor, Dhanvantri complex
SMS Hospital, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9964272323 |
| Fax |
|
| Email |
prabhuharvi@gmail.com |
|
|
Source of Monetary or Material Support
|
| SAWAI MAN SINGH MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
SMS Medical College |
| Address |
Department of Anesthesia Dhanwantri building,SMS Medical college |
| 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 vandana mangal |
SMS medical college and hospital |
Department of Anesthesiology, Second floor, Dhanwantri Building,SMS Hospital, JLN Marg, Jaipur Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
9829056816
vandanamangal25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, SMS Medical College, Jaipur |
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 |
Costoclavicular brachial plexus block |
20ml 0.5% Ropivacaine injected in the costoclavicular brachial plexus and then diaphragm movement is assessed at 0,30,60mins after the block |
| Comparator Agent |
Occurrence of Hemidiaphragmatic Paralysis in Patients Receiving Ultrasound guided Costoclavicular v/s Supraclavicular Block in Upper limb Surgeries |
comparision in terms of hemiphragmatic paralysis |
| Intervention |
Supraclavicular brachial plexus block |
20ml 0.5% Ropivacaine injected in the supraclavicular brachial plexus and then diaphragm movement is assessed at 0,30,60mins after the block |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients posted for upperlimb surgeries
ASA grade 1-2
weight 40-90kgs |
|
| ExclusionCriteria |
| Details |
patients not willing to participate
rib fracture , icd for pneumothorax , allergic to local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine the difference in mean height of hemidiaphragm before, 30 and 60 mins after block in patients using Ultrasonography
to determine difference in MEAN PEFR
|
1.To determine the difference in mean height of hemidiaphragm before, 30 and 60 mins after block in patients using Ultrasonography
to determine difference in MEAN PEFR
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in mean PEFR is calculated |
0mins ,30 mins , 60 mins |
|
|
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)
|
20/10/2023 |
| 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="2"
Days="15" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Data will be stored and managed by principle investigator
- For how long will this data be available start date provided 20-10-2023 and end date provided 24-09-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patient satisfying inclusion criteria will be selected and taken in OT Patient identity will be confirmed, PAC will be done and informed written consent will be checked. Noninvasive monitors (NIBP,Pulse oximeter,ECG) will be monitored and ringer lactate will be started intravenously Patient will lie in supine position, with the head turned to the opposite side. Under all aseptic precautions, ultrasound guided brachial plexus block will be performed after explaining the procedure in each group. Using sonosite micromaxx high frequency linear probe Group A (n=30) USG guided supraclavicular block given by injecting 20ml of 0.5% Ropivacaine Group B(n=30) USG guided costoclavicularblock given by injecting 2oml 0.5% Ropivacaine Assessment of the diaphragmatic movement by ultrasonography will be done at 0mins, 30, 60 minutes after block intraoperative hemodynamic parameters NIBP, HR and PEFR will be recorded |