| CTRI Number |
CTRI/2022/02/040644 [Registered on: 25/02/2022] Trial Registered Prospectively |
| Last Modified On: |
23/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare effect of TRAMADOL versus DEXMEDETOMIDINE as an addition to ROPIVACAINE for upper extremity surgery. |
|
Scientific Title of Study
|
A comparative study of the effect of addition of TRAMADOL or DEXMEDETOMIDINE as an adjunct to local anesthetic ROPIVACAINE for supra clavicular brachial plexus block in upper extremity surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita Kothari |
| Designation |
M D Anaesthesiology Resident |
| Affiliation |
B.J. Medical College,Ahmedabad. |
| Address |
F3 Department of Anaesthesia BJMC Civil Hospital Asarwa Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426114055 |
| Fax |
|
| Email |
nkothari255@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chirag Patel |
| Designation |
Assistant Professor |
| Affiliation |
B.J. Medical College, Ahmedabad. |
| Address |
F3 Department of Anaesthesia BJMC Civil Hospital Asarwa Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9898126456 |
| Fax |
|
| Email |
drchiragpateld10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikita Kothari |
| Designation |
M D Anaesthesiology Resident |
| Affiliation |
B.J. Medical College, Ahmedabad. |
| Address |
F3 Department of Anaesthesia BJMC Civil Hospital Asarwa Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426114055 |
| Fax |
|
| Email |
nkothari255@gmail.com |
|
|
Source of Monetary or Material Support
|
| F3 Department of Anaesthesiology BJMC Civil hospital Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Government Supply |
| Address |
F3 Department of Anaesthesiology BJMC Civil hospital Ahmedabad |
| 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 |
| Nikita Kothari |
BJMC Civil Hospital Ahmedabad |
F3 Department of Anaesthesiology
Ahmadabad
GUJARAT |
9426114055
nkothari255@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee B J Medical College Civil Hospital Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SupraClavicular Brachial Plexus Block with Ropivacaine and Dexmedetomidine |
Giving SupraClavicular Brachial Plexus block with 0.5% Ropivacaine 30 ml +1mcg/kg Dexmedetomidine in 52 patients and observing effects till 24 hours after surgery. |
| Comparator Agent |
SupraClavicular Brachial Plexus Block with Ropivacaine and Tramadol |
Giving SupraClavicular Brachial plexus block with 0.5% ropivacaine 30ml and 100mg Tramadol in 52 patients and observing effects till 24 hours after surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I,II,III
Elective and Emergency surgery
Unilateral upper limb surgery
|
|
| ExclusionCriteria |
| Details |
Hemodynamic instability
unwilling patient
History of hypersensitivity to drug
Local infection/inflammation
Patient having coagulopathy/Neuropathy
Unconscious patient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase duration of block and analgesia with less side effect and complications. |
Post operative period up to 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease duration of onset of block |
After giving block up to 30 mins |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
01/03/2022 |
| 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="1"
Days="1" |
|
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
|
Addition of Dexmedetomidine or Tramadol as an adjunct to local anesthetic Ropivacaine for Supra Clavicular Brachial Plexus Block in upper extremity surgery can decrease onset of sensory and motor block, increase duration of sensory and motor block, improve duration of analgesia without increased incidence of adverse effect. |