| CTRI Number |
CTRI/2021/01/030400 [Registered on: 12/01/2021] Trial Registered Prospectively |
| Last Modified On: |
11/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparision of two drugs in nerve block for patients undergoing upper limb surgeries. |
|
Scientific Title of Study
|
A comparative study between Clonidine and Dexamethasone as an adjuvant to 0.5% Bupivacaine in 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 |
KATYPALLY NAVEENA |
| Designation |
POST GRADUATE TRAINEE FIRST YEAR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, PBMH, KALINGA INSTITUTE OF MEDICAL SCIENCES
Khordha
ORISSA
751024
India |
| Phone |
9975111564 |
| Fax |
|
| Email |
2087032@kims.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR TAPAN KUMAR RAY |
| Designation |
Professor |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, PBMH, KALINGA INSTITUTE OF MEDICAL SCIENCES
Khordha
ORISSA
751024
India |
| Phone |
9861046212 |
| Fax |
|
| Email |
tapankumarray.ray@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KATYPALLY NAVEENA |
| Designation |
POST GRADUATE TRAINEE FIRST YEAR |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, PBMH, KALINGA INSTITUTE OF MEDICAL SCIENCES
Khordha
ORISSA
751024
India |
| Phone |
9975111564 |
| Fax |
|
| Email |
2087032@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| KALINGA INSTITUTE OF MEDICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
KATYPALLY NAVEENA |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, PBMH, KALINGA INSTITUTE OF MEDICAL SCIENCES,751024 |
| 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 |
| KATYPALLY NAVEENA |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF ANAESTHESIOLOGY, PBMH, KALINGA INSTITUTE OF MEDICAL SCIENCES
Khordha
ORISSA |
9975111564
2087032@kims.ac.in |
|
|
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: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK |
TWO DRUGS(CLONIDINE 50 micrograms AND DEXAMETHASONE 4 milligram)WILL BE ADDED TO LOCAL ANAESTHETIC (0.5% BUPIVACAINE 20 milliliter) IN SUPRACLAVICULAR BLOCK IN PATIENTS UNDERGOING UPPER LIMB SURGERIES |
| Comparator Agent |
SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK |
TWO DRUGS(CLONIDINE 50 micrograms AND DEXAMETHASONE 4 milligram)WILL BE ADDED TO LOCAL ANAESTHETIC (0.5% BUPIVACAINE 20 milliliter) IN SUPRACLAVICULAR BLOCK IN PATIENTS UNDERGOING UPPER LIMB SURGERIES |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with American society of anaesthesiologists (ASA) physical status I and II undergoing upper limb surgeries under brachial plexus block. |
|
| ExclusionCriteria |
| Details |
1.Infection at the injection site.
2.Presence of coagulopathies.
3.Known and tested hypersensitivity to Bupivacaine, Clonidine and Dexamethasone drugs.
4.Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome measure in this study is the onset of sensory and motor block at baseline |
The primary outcome measure in this study is the onset of sensory and motor block at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome measure in the study is the duration of sensory and motor block. |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/01/2021 |
| 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="1"
Months="6"
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
|
Brachial plexus block is widely used as an alternative to general anaesthesia for upper extremity surgeries. In this study, one group will receive Clonidine with Bupivacaine and the second group will receive Dexamethasone with Bupivacaine. Both groups will be compared on the basis of onset and duration of sensory and motor block. |