| CTRI Number |
CTRI/2021/11/038117 [Registered on: 18/11/2021] Trial Registered Prospectively |
| Last Modified On: |
17/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE STUDY BETWEEN DEXMEDETOMIDINE VERSUS DEXAMETHASONE ALONG WITH 0.5% ROPIVACAINE IN ANAESTHEIC BLOCK GIVEN UNDER ULTRASOUND GUIDANCE AT SUPRACLAVICULAR AREA FOR UPPER LIMB SURGERIES |
|
Scientific Title of Study
|
A COMPARATIVE STUDY BETWEEN DEXMEDETOMIDINE VERSUS DEXAMETHASONE AS ADJUVANT TO 0.5% ROPIVACAINE IN ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANUKRISHNA K V |
| Designation |
JUNIOR RESIDENT OF MD ANAESTHESIOLOGY |
| Affiliation |
MGM Medical College and Hospital Aurangabad Maharashtra |
| Address |
Department of Anaesthesia
2nd floor MGM MEDICAL COLLEGE AND HOSPITAL
CIDCO N6 AURANGABAD
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7012861162 |
| Fax |
|
| Email |
anukrishnakv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRAMOD VASANTRAO BHALE |
| Designation |
PROFESSOR IN DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
MGM Medical College and Hospital Aurangabad Maharashtra |
| Address |
Department of Anaesthesia
2nd floor MGM MEDICAL COLLEGE AND HOSPITAL
CIDCO N6 AURANGABAD
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
8888819021 |
| Fax |
|
| Email |
pramod.bhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANUKRISHNA K V |
| Designation |
UNIOR RESIDENT OF MD ANAESTHESIOLOGY |
| Affiliation |
MGM Medical College and Hospital Aurangabad Maharashtra |
| Address |
Department of Anaesthesia
2nd floor MGM MEDICAL COLLEGE AND HOSPITAL
CIDCO N6 AURANGABAD
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7012861162 |
| Fax |
|
| Email |
anukrishnakv@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM MEDICAL COLLEGE AND HOSPITAL, AURANGABAD, MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
Dr Anukrishna K V |
| Address |
Department of anaesthesia, MGM medical college and hospital, Cidco N6, Aurangabad |
| 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 Anukrishna KV |
MGM Medical college And Hospital |
Department of Anaesthesiology, Room No. 570, MGM Medical college And Hospital
Cidco N6, Aurangabad
Aurangabad
MAHARASHTRA |
7012861162
anukrishnakv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHATHMA GANDHI MISSIONS ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I70-I79||Diseases of arteries, arterioles and capillaries, (2) ICD-10 Condition: S50-S59||Injuries to the elbow and forearm, (3) ICD-10 Condition: S60-S69||Injuries to the wrist, hand and fingers, (4) ICD-10 Condition: M259||Joint disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone |
To check the effect of drug as an adjuvant in onset and duration of sensory and motor blockade and on duration of analgesia and maintaining hemodynamic stability.
Dose-4mg dexamethasone |
| Comparator Agent |
Dexmedetomidine |
To check the effect of drug as an adjuvant in onset and duration of sensory and motor blockade and on duration of analgesia and maintaining hemodynamic stability.
Dose- Dexmedetomidine 1microg/kg diluted to a total of 1mL |
| Intervention |
Supraclavicular brachial plexus block |
Group- RD- 20mL of 0.5% Ropivacaine+Dexmedetomidine 1microg/kg diluted to total of 1mL
Group RX- 20mL of 0.5% Ropivacaine + Dexamethasone 4mg |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Weight between 45 to 70Kgs, posted for elective and emergency surgeries below midarm, forearm and hand will be included |
|
| ExclusionCriteria |
| Details |
History of infection at site of block, history of coagulopathies, patients with known hypersensitivity to local anaesthetic or any study drug, patient with known hypersensitivity to local anaesthetic or any study drug, Patient with presence of 1st, 2nd or 3rd degree heart block, Pregnant women, Patient with pre-existing peripheral neuropathy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the onset of sensory blockade and motor blockade, duration of sensory and motor blockade, duration of analgesia |
0,5, 10, 15, 20, 40, 60, 80, 100, 120, 140, 160 400, 640, 880, 1360, 1600 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the total consumption of rescue analgesia in 24 hour postoperatively and to monitor hemodynamic stability |
0,5, 10, 15, 20, 40, 60, 80, 100, 120, 140, 160 400, 640, 880, 1360, 1600 minutes |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
19/11/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a comparative study between 2 drugs- dexmedetomidine and dexamethasone when added to another drug ropivacaine when used in ultrasound guided supraclavicular brachial plexus block. Monitoring will be done for onset and duration of sensory and motor blockade, and will be monitored postoperatively for duration of analgesia. Changes in vitals also will be recorded. |