| CTRI Number |
CTRI/2023/07/055884 [Registered on: 31/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare duration of pain relief between Perineural and Intravenous Dexamethasone in Brachial Plexus block for upper limb surgeries |
|
Scientific Title of Study
|
A comparison between Perineural and Intravenous Dexamethasone on duration of Analgesia in Brachial Plexus block |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IECKMCMLR-03/2023/84 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siddhartha Sahana |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Lighthouse Hill Road Mangalore
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
8777263167 |
| Fax |
|
| Email |
siddharthasahana85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Bhat |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Department of Anaesthesiology Kasturba Medical College
Light House Hill Road Mangalore
Dakshina Kannada
Karnataka
575001
India
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9980014995 |
| Fax |
|
| Email |
sonal.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Bhat |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Department of Anaesthesiology Kasturba Medical College
Lighthouse Hill Road Mangalore
Dakshina Kannada
Karnataka
575001
India
Dakshina Kannada
KARNATAKA
575003
India |
| Phone |
9980014995 |
| Fax |
|
| Email |
sonal.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education Manipal, Dakshin Kannada, Karnataka,576104 |
|
|
Primary Sponsor
|
| Name |
Dr Siddhartha Sahana |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Light House Hill Road
Mangalore 575001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Siddhartha Sahana |
Kasturba Medical College Mangalore |
Department of Anaesthesiology
Kasturba Medical College Mangalore
575003
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA |
8777263167
siddharthasahana85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Kasturba Medical College Mangalore |
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) All individual in both genders between 18 to 70 years
2) Patients undergoing elective upper limb surgery under brachial plexus block
3)American society of Anaesthesiologist physical status I,II,III. |
|
| ExclusionCriteria |
| Details |
1) Patients not willing to participate
2) Patients on prolonged steroid theraphy
3) History of allergy to local anaesthetics
4) Infection at block site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Analgesia |
Immediately
At 12 hours
At 24 hours
At 36 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Assess post operative nausea & vomiting
Requirement of first rescue analgesia
Side effects if any |
Immediate
At 12 hours
At 24 hours
At 36 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/08/2023 |
| 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="1"
Months="5"
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 - NO
|
|
Brief Summary
|
To compare the duration of analgesia in patients by giving 4 mg dexamethasone between perineural and intravenous route in adult patients undergoing upper limb surgeries under brachial plexus block To look for any post operative nausea and vomiting If any rescue analgesia required
|