| CTRI Number |
CTRI/2013/04/003598 [Registered on: 30/04/2013] Trial Registered Prospectively |
| Last Modified On: |
29/04/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
UPPER LIMB BLOCK USING DEXMEDETOMIDINE. |
|
Scientific Title of Study
|
Alpha2agonist Dexmedetomidine as an adjuvent to local anaesthesia for Supraclavicular block. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishali Waindeskar |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Sciences and Research Center. |
| Address |
PCMS and RC
Bhanpur
Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554005200 |
| Fax |
|
| Email |
vaishaliwaind@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Waindeskar |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Sciences and Research Center. |
| Address |
PCMS and RC
Bhanpur
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554005200 |
| Fax |
|
| Email |
vaishaliwaind@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Waindeskar |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Sciences and Research Center. |
| Address |
PCMS and RC
Bhanpur
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554005200 |
| Fax |
|
| Email |
vaishaliwaind@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Peoples Hospital |
| Address |
Department of Anesthesia Peoples College of Medical Sciences and
Research Center Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Type of Sponsor |
Private 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 Vaishali Waindeskar |
Peoples Hospital |
Department of Anesthesia Peoples College of Medical Sciences and
Research Center Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India
Bhopal
MADHYA PRADESH |
09575604490
vaishaliwaind@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 |
Patients undergoing upper limb surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Supraclavicular block using Inj Bupivacaine 0.25% + Dexmedetomedine 30 mcg |
Group D : Inj Bupivacaine 0.25% + Dexmedetomedine 30 mcg total Volume 30 ml |
| Comparator Agent |
Supraclavicular block using Inj Bupivacaine 0.25 % + normal saline |
Group C : Inj Bupivacaine 0.25% + Normal Saline total volume 30 ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2 patients posted for upper limb surgeries |
|
| ExclusionCriteria |
| Details |
ASA 3 and ASA 4 patients
Patients with neurological deficit
Patients with history of seizures
Patients with bleeding disorders
Patients with pneumothorax
Patient with pregnancy
Uncooperative patient
Patients refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset of Sensory block
Duration of Sensory block
Onset of Motor block
Duration of Motor block
Hemodynamic changes
Demand of Analgesia
Any other adverse effects |
Till the requirements of first analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 4 |
|
Date of First Enrollment (India)
|
15/05/2013 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Randomized double blind case control study :
GROUP C (n=30) receives 0.25% plain Bupivacaine + 0.3 ml Normal Saline total volume 30 ml.
GROUP D (n=30) receives 0.25% Bupivacaine + 0.3 ml Dexmedetomidine (30µg) total volume 30 ml. Through supraclavicular approach with the aid of a nerve stimulator, by using a 22 G short beveled, insulated 25mm stimulating needle. |