| CTRI Number |
CTRI/2025/03/081904 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How Adding Dexmedetomidine and Dexamethasone to Levobupivacaine Can Improve Pain Relief in Arm Nerve Blocks.
How Adding Dexmedetomidine and Dexamethasone to Levobupivacaine Can Improve Pain Relief in Arm Nerve Blocks |
|
Scientific Title of Study
|
Efficacy of Dexmedetomidine and Dexamethasone as adjuvents to Levobupivacaine in ultrasound guided 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 |
Dr Vikas Mujalda |
| Designation |
Junior Resident In Department In Anaesthesiology |
| Affiliation |
Gandhi Medical College |
| Address |
Operation Theatre 2nd Floor Block-1,Department Of
Anaesthesiology,Gandhi Medical College,Bhopal
Bhopal
Madhya Pradesh
462001 India
Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7415335741 |
| Fax |
|
| Email |
dr.vikasmujalde1986@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelesh Nema |
| Designation |
Assistant Professor |
| Affiliation |
Gandhi Medical College Bhopal |
| Address |
Operation Theatre 2nd Floor Block-1,Department Of
Anaesthesiology,Gandhi Medical College,Bhopal
Bhopal
Madhya Pradesh
462001 India
Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9893427372 |
| Fax |
|
| Email |
neeleshnema@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelesh Nema |
| Designation |
Assistant Professor |
| Affiliation |
Gandhi Medical College Bhopal |
| Address |
Operation Theatre 2nd Floor Block-1,Department Of
Anaesthesiology,Gandhi Medical College,Bhopal
Bhopal
Madhya Pradesh
462001 India
Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9893427372 |
| Fax |
|
| Email |
neeleshnema@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Gandhi medical College, Bhopal, Madhya Pradesh, India,
462001 |
|
|
Primary Sponsor
|
| Name |
Gandhi Medical College |
| Address |
Gandhi medical college, Bhopal, MP, India, 462001 |
| 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 |
| Head Of The Department |
Gandhi Medical College,Bhopal |
Operation theatre 2nd
floor Block-1,
Department of
Anaesthesiology ,Gandhi Medical College,
Bhopal
Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH |
7415335741
dr.vikasmujalde1986@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S529||Unspecified fracture of forearm, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II |
|
| ExclusionCriteria |
| Details |
1.Coagulation abnormalities / bleeding diathesis
2. Patients having a history of diaphragmatic palsy, significant
cardiac, respiratory, hepatic, renal, neurological, psychiatric,
or neuromuscular comorbidities.
3.History of allergic reactions to local anesthetic agent. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the onset of sensory and motor block
between two groups.
|
120 minutes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the duration of analgesia between two
groups.
|
120 minutes |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| 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="6"
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
|
Patients will be observed for :- 1) Onset of sensory block. 2) Duration of sensory block. 3) Onset of motor block. 4) Duration of motor block 5) VAS 6) Complications |