CTRI

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CTRI Number

CTRI/2024/01/062007 [Registered on: 30/01/2024] Trial Registered Prospectively

Last Modified On:

25/01/2024

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparative Study of Dexmedetomidine, Dexamethasone, and Clonidine Drugs With Ropivacaine in Upper Limb Surgery Under Supraclavicular Brachial Plexus Block.

Scientific Title of Study

"A Clinical Comparative Study Of Dexmedetomidine, Dexamethasone And Clonidine As Adjuvants To Local Anaesthetics In 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	UMESH PRASAD YADAV
Designation	PG Resident Anesthesiology
Affiliation	Gajra Raja Medical College, Gwalior M.P.
Address	Department of anaesthesiology JAH Campus Gwalior M.P. Gwalior MADHYA PRADESH 474001 India
Phone	9752048204
Fax
Email	drumeshyadav0707@gmail.com

Details of Contact Person
Scientific Query

Name	DR JITENDRA AGRAWAL
Designation	Professor
Affiliation	Gajra Raja Medical College, Gwalior M.P.
Address	Department of Anesthesiology and JAH Campus Gwalior Gwalior MADHYA PRADESH 474001 India
Phone	9300009942
Fax
Email	drjagrawal9@gmail.com

Details of Contact Person
Public Query

Name	DR JITENDRA AGRAWAL
Designation	Professor
Affiliation	Gajra Raja Medical College, Gwalior M.P.
Address	Department of Anesthesiology and JAH Campus Gwalior Gwalior MADHYA PRADESH 424001 India
Phone	9300008842
Fax
Email	drjagrawal9@gmail.com

Source of Monetary or Material Support

GAJRA RAJA MEDICAL COLLEGE GWALIOR M.P.

Primary Sponsor

Name	UMESH PRASAD YADAV
Address	Department of anaesthesiology JAH CAMPUS GWALIOR M.P.
Type of Sponsor	Other [SELF]

Details of Secondary Sponsor

Name	Address
NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Jitendra Agrawal	Gajra Raja Medical College And Hospital Gwalior M.P.	Department of anaesthesiology, Gajra Raja Medical College Gwalior M.P. Gwalior MADHYA PRADESH	9300009942 drjagrawal9@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
GAJRA RAJA MEDICAL COLLEGE GWALIOR M.P.	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type

Condition

Patients

(1) ICD-10 Condition: S520||Fracture of upper end of ulna, (2) ICD-10 Condition: S521||Fracture of upper end of radius, (3) ICD-10 Condition: S522||Fracture of shaft of ulna, (4) ICD-10 Condition: S523||Fracture of shaft of radius, (5) ICD-10 Condition: S525||Fracture of lower end of radius, (6) ICD-10 Condition: S526||Fracture of lower end of ulna, (7) ICD-10 Condition: S518||Open wound of forearm,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Clonidine with Lignocaine-Adrenaline To Ropivacaine	Clonidine(1micro/kg) (2ml) with Lignocaine-Adrenaline (10ml) To Ropivacaine (0.5%) (20ml) (Total Volume 32ml)In Supraclavicular Brachial Plexus Block.(30 patient each of total duration 18 months)
Comparator Agent	Dexamethasone with Lignocaine-Adrenaline TO Ropivacaine	Dexamethasone 2ml (8mg) with Lignocaine-Adrenaline (10ml) Ropivacaine (0.5%) (20ml) (Total Volume 32 ml) In Supraclavicular Brachial Plexus Block.(30 patient each of total duration 18 months)
Comparator Agent	Dexmedetomidine with Lignocaine-Adrenaline To Ropivacaine	Dexmedetomidine (2ml) (1micro/kg) with Lignocaine-Adrenaline (10ml) To Ropivacaine (0.5%) (20ml) (Total Volume 32ml) In Supraclavicular Brachial Plexus Block.(30 patient each of total duration 18 months)
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	90 Patients ASA Grade I and II

ExclusionCriteria

Details

History of allergy or any other reaction to local anesthetics
Hypertensive patients
Renal dysfunction
Cardiac disease
Bleeding disorder
Deranged LFT

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Double Blind Double Dummy

Primary Outcome

Outcome	TimePoints
In The Upper Extremity Surgeries Performed Under Supraclavicular Block Dexmedetomidine is Superior to Clonidine and Dexamethasone due to its Prolonged duration of analgesia, faster onset of action and better quality of sensory and motor block	Baseline

Secondary Outcome

Outcome	TimePoints
nil	nil

Target Sample Size

Total Sample Size="90"
Sample Size from India="90"
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 4

Date of First Enrollment (India)

05/02/2024

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="8"
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

To evaluate and compare the onset and duration of sensory and motor blockade of 0.5% Ropivacaine with Dexmedetomidine, Dexamethasone and Clonidine in supraclavicular brachial plexus blockade.

Dexmedetomidine as adjuvant to local anesthetic in supra clavicular block may provide faster onset , prolonged duration of block and better quality of analgesia.