| CTRI Number |
CTRI/2024/01/061827 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare effectiveness and safety between blocks given to neck region for upper arm surgeries using ultrasound guidance and peripheral nerve stimulator needle guidance. |
|
Scientific Title of Study
|
A comparative clinical study of ultrasound guided versus peripheral nerve stimulator technique of Interscalene brachial plexus block in upper arm surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi B M |
| Designation |
Postgraduate student |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Departmet of Anaesthesiology, First floor, New stone building, KR hospital, Mysore Medical College and Research Institute, Irwin road, Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9480325546 |
| Fax |
|
| Email |
rashmibmrashmibm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H G Manjunath |
| Designation |
Professor and Head of the Department, Department of Anaesthesiology |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Departmet of Anaesthesiology, First floor, New stone building, KR hospital, Mysore Medical College and Research Institute, Irwin road, Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9448054368 |
| Fax |
|
| Email |
drhgmanjunath@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi B M |
| Designation |
Postgraduate student |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Departmet of Anaesthesiology, First floor, New stone building, KR hospital, Mysore Medical College and Research Institute, Irwin road, Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
9480325546 |
| Fax |
|
| Email |
rashmibmrashmibm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mysore medical college and research institute |
|
|
Primary Sponsor
|
| Name |
Mysore medical college and research institute |
| Address |
Irwin road , next to railway station , mysore Karnataka 570001 |
| 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 Rashmi B M |
Krishna Rajendra hospital |
Mysore medical college and research institute , department of anaesthesia ,1st floor , room no 1 new stone building Kr hospital Irwin road mysore Karnataka
Mysore
KARNATAKA |
9480325546
rashmibmrashmibm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mysore medical college and research institute and associated hospitals , mysore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: M844||Pathological fracture, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Peripheral nerve stimulator guided Interscalene brachial plexus block using 20ml 0.75% Ropivacaine and 4mg Dexamethasone block for upper arm surgeries |
Monitoring time interval between identification of anatomical landmarks and needle removal after drug administration, time taken for sensory blockade, time taken for motor blockade and any inadvertent vascular punctures |
| Intervention |
Ultrasound guided Interscalene brachial plexus block for upper arm surgeries using 20ml 0.75% Ropivacaine and 4mg Dexamethasone |
Monitoring the time interval between the first ultrasound scan to needle removal after drug administration, time taken for sensory blockade, time taken for motor blockade and any inadvertent vascular puncture |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either sex , aged between 18- 55 years belonging to ASA class 1 and class 2 without any severe comorbid diseases scheduled for elective upper arm surgeries |
|
| ExclusionCriteria |
| Details |
Age less then 18 years and more than 55 years
ASA class 3 , 4 , 5
Cardiovascular , respiratory an neurological disorders and myopathies |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses procedural time, onset of sensory and motor block, number of inadvertent vascular punctures between ultrasound guided and peripheral nerve stimulator method Interscalene brachial plexus block in upper arm surgeries |
30min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out hemodynamic parameters; heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure at various intervals following Interscalene brachial plexus comparing ultrasound guided and peripheral nerve stimulator methods |
3 hours |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="0"
Days="0" |
|
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
Response - Clinical Study Report
Response - Analytic Code
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rashmibmrashmibm@gmail.com].
- For how long will this data be available start date provided 25-01-2024 and end date provided 03-01-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This study is conducted to compare the effectiveness and safety between ultrasound guided versus peripheral nerve stimulator guided Interscalene brachial plexus block for upper arm surgeries |