| CTRI Number |
CTRI/2020/07/026913 [Registered on: 30/07/2020] Trial Registered Prospectively |
| Last Modified On: |
29/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Efficacy of Dexmedetomidine V/S Fentanyl as an Adjuvant to 0.5%Ropivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Block in Upper Limb Surgery
|
|
Scientific Title of Study
|
Comparison of Efficacy of Dexmedetomidine V/S Fentanyl as an Adjuvant to 0.5% Ropivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Block in Upper Limb Surgery: a Randomized, Double Blind Interventional Study
in SMS Hospital, Jaipur, During 2019-21. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam kalra |
| Designation |
Senior professor |
| Affiliation |
SMS medical college |
| Address |
Department of anaesthesia
Second floor
SMS medical college
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413416787 |
| Fax |
|
| Email |
poonamkalra24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam kalra |
| Designation |
Senior professor |
| Affiliation |
SMS medical college |
| Address |
Department of anaesthesia
Second floor
SMS medical college
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413416787 |
| Fax |
|
| Email |
poonamkalra24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Choudhary |
| Designation |
Junior resident |
| Affiliation |
SMS medical college |
| Address |
Department of anaesthesia
SMS medical college
Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9602056219 |
| Fax |
|
| Email |
choudharym095@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia, SMS medical college, JLN marg, jaipur |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesia SMS medical college JLN marg Jaipur rajasthan |
| Address |
Department of anaesthesia, SMS medical college, JLN marg, Jaipur, rajasthan, 302004 |
| 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 |
| Dr Poonam kalra |
SMS medical college jaipur |
Department of anaesthesia
Second floor
Dhanwantri building
Jaipur
Jaipur
RAJASTHAN |
9413416787
poonamkalra24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS medical college, Ethics committee,jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S523||Fracture of shaft of radius, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexemedetomidine 1mcg/kg |
Dexemedetomidine 1mcg/kg diluted in saline up to 2ml with 28ml 0.5%ropivacaine total volume 30ml for ultrasound guided supraclavicular brachial plexus block |
| Comparator Agent |
Fentanyl 1mcg/kg |
Fentanyl 1mcg/kg diluted in saline up to 2ml with 28ml 0.5% ropivacaine total volume 30ml for ultrasound guided supraclavicular brachial plexus block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgical procedure on upper limb of duration 1-4 hours
Patients willing to give written and informed consent
Patients belonging to ASA class-I and II |
|
| ExclusionCriteria |
| Details |
Uncooperative patients
Local pathology at the injection site
Disability limiting the performance of block
History of convulsion, severe neurological deficit
Allergy to the drug used
Bleeding disorders, coagulopathies
Patients with history of respiratory,cardiac,hepatic and renal disease
Chronic use of opioid or any other analgesics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
For significance in difference in mean variable i.e., outcome variables 1-5 --- Student unpaired T test of significance
|
24 hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
For significance in difference in median VAS score i.e., outcome variable 6 --- Mann Whitney Test
For significance in difference in proportion of cases with complications i.e., outcome variable 7 --- Chi square test of significance |
24hours post operative |
|
|
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)
|
31/07/2020 |
| 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="8"
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
|
In our study we are comparing efficacy of dexmedetomidine and fentanyl as an adjuvant to 0.5% ropivacaine in usg guided supraclavicular block in upper limb surgeries.To find out onset and duration of sensory and motor block. Comparison of duration of post operative analgesia. |