| CTRI Number |
CTRI/2024/03/064718 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Examining the effectiveness of two different doses of dexamethasone when used as an additive to upper limb nerve block |
|
Scientific Title of Study
|
Dose response of dexamethasone as an adjuvant for supraclavicular 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 |
Divya Prabhash |
| Designation |
Junior Resident Anaesthesia |
| Affiliation |
Kasturba Medical College Hospital Manipal |
| Address |
Department of Anesthesiology, KMC Manipal, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8157021046 |
| Fax |
|
| Email |
divyaprabhash@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajaram H Prabhu |
| Designation |
Senior Resident Anaesthesia |
| Affiliation |
Kasturba Medical College Hospital Manipal |
| Address |
Department of Anesthesiology, KMC Manipal, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845835499 |
| Fax |
|
| Email |
rajaramprabhu007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Prabhash |
| Designation |
Junior Resident Anaesthesia |
| Affiliation |
Kasturba Medical College Hospital Manipal |
| Address |
Department of Anesthesiology, KMC Manipal, 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8157021046 |
| Fax |
|
| Email |
divyaprabhash@outlook.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Kasturba Medical College Hospital |
|
|
Primary Sponsor
|
| Name |
Divya Prabhash |
| Address |
Department of Anesthesiology, KMC Manipal, 576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Divya Prabhash |
Kasturba Medical College Hospital |
Old Trauma Complex, Department of Anesthesiology, KMC Manipal, 576104
Udupi
KARNATAKA |
8157021046
divyaprabhash@outlook.com |
| Divya Prabhash |
Kasturba Medical College Hospital |
Main OT Complex, Department of Anesthesiology, KMC Manipal, 576104
Udupi
KARNATAKA |
8157021046
divyaprabhash@outlook.com |
| Divya Prabhash |
Kasturba Medical College Hospital Manipal |
New Trauma Complex,Department of Anesthesiology, KMC Manipal, 576104
Udupi
KARNATAKA |
08157021046
divyaprabhash@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S698||Other specified injuries of wrist,hand and finger(s), (2) ICD-10 Condition: S599||Unspecified injury of elbow and forearm, (3) ICD-10 Condition: S499||Unspecified injury of shoulder andupper arm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone 2mg |
Documenting dose response when dexamethasone 2mg is used as additive to supraclavicular brachial plexus block. |
| Comparator Agent |
Dexamethasone 4mg |
Documenting dose response when dexamethasone 4mg is used as additive to supraclavicular brachial plexus block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing upper limb surgeries under supraclavicular brachial plexus block. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Neurological deficits involving brachial plexus
3. Patients with diabetes mellitus, hepatic or renal failure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine onset of sensory blockade with two different doses of dexamethasone as adjuvant to block. |
In minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine duration of sensory blockade with two different doses of dexamethasone as adjuvant to block. |
In minutes |
| Onset and Duration of motor blockade |
In minutes |
| Side Effects / Complications |
(If any) |
|
|
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)
|
10/04/2024 |
| 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="0"
Months="0"
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
|
Title : Dose response of dexamethasone as an adjuvant for supraclavicular brachial plexus nerve block Type of Study : Prospective observational study Aim : To compare block characteristics with two different doses of dexamethasone (2mg vs 4mg) as adjuvant in ultrasound guided brachial plexus block. |