| CTRI Number |
CTRI/2020/08/027358 [Registered on: 24/08/2020] Trial Registered Prospectively |
| Last Modified On: |
24/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of pain relieving efficacy of Dexmedetomidine, Fentanyl and Dexamethasone as an adjuvant to Ropivacaine in above the Collar bone Brachial plexus block (USG guided) when administered perineurally in adult patients undergoing upper limb surgery . |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of Dexmedetomidine, Fentanyl and Dexamethasone as an adjuvant to Ropivacaine in Supraclavicular Brachial plexus block (USG guided) when administered perineurally in adult patients undergoing upper limb surgery : A randomized comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pradeep Kumar Mulewa |
| Designation |
PG resident 3rd year |
| Affiliation |
Dr S. N Medical College |
| Address |
Office,deptt. Of anesthesia ,M.G hospital affiliated to Dr Sampurnanand Medical College, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342001
India |
| Phone |
08005657338 |
| Fax |
|
| Email |
Pradeepmulewa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas Rajpurohit |
| Designation |
Professor |
| Affiliation |
Dr S. N Medical College, Jodhpur |
| Address |
Trauma ICU ,MDM Hospital affiliated to Dr Sampurnanand Medical College, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9928060011 |
| Fax |
|
| Email |
drvikasrajpurohit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pradeep Kumar Mulewa |
| Designation |
PG resident 3rd year |
| Affiliation |
Dr S. N Medical College, Jodhpur |
| Address |
Department of Anaesthesia ,Dr Sampurnanand Medical College, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342001
India |
| Phone |
08005657338 |
| Fax |
|
| Email |
Pradeepmulewa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sampurnanand medical college ,jodhpur,Rajasthan 342001 |
|
|
Primary Sponsor
|
| Name |
Dr Sampurnanand Medical College Jodhpur |
| Address |
Dr Sampurnanand Medical college, jodhpur |
| 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 |
| Pradeep kumar Mulewa |
MDM Hospital, Dr Sampurnanand medical college jodhpur |
Orthopaedics OT,MDM hospital,Dr Sampurnanand medical college jodhpur, rajasthan
Jodhpur
RAJASTHAN |
08005657338
Pradeepmulewa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr Sampurnanand medical college, Jodhpur |
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 |
| Comparator Agent |
Ropivacaine
Dexmedetomidine
Dexamethasone
fentanyl
|
Ropivacaine 0.5% 30ML with Dexmedetomidine 100 mcg
Ropivacaine 0.5% 30ML with Dexamethasone 8 mg
Ropivacaine 0.5% 30ML with fentanyl 100mcg
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged 20 to 60 years of either gender of ASA physical statue I and II undergoing upper limb surgery who willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal,
2. Hypersensitivity to amide local anaesthetics according to past history
3. Hypersensitivity to fentanyl, dexamethasone, dexmedatomidine infection at the injection site
4. Pregnant woman ( Urine Pregnancy Test positive)
5. Obesity (BMI >30kg/m2 )
6. Uncooperative patients
7. Anatomical abnormality at the site of injection
8. Bleeding disorders ( Deranged PT-INR , Clotting time and Bleeding time)
9. Peripheral neuropathy or neurological deficit ( Based on history of neurological disease and Clinical Neurological assessment- Fine Touch, Pin Test, Motor power)
10. Concurrent chronic analgesic therapy
11. Known hepatic or renal insufficiency( Deranged LFT, SGOT, SGPT, Serum Creatinine, Blood Urea)
12. Field block1. Patient refusal,
2. Hypersensitivity to amide local anaesthetics according to past history
3. Hypersensitivity to fentanyl, dexamethasone, dexmedatomidine infection at the injection site
4. Pregnant woman ( Urine Pregnancy Test positive)
5. Obesity (BMI >30kg/m2 )
6. Uncooperative patients
7. Anatomical abnormality at the site of injection
8. Bleeding disorders ( Deranged PT-INR , Clotting time and Bleeding time)
9. Peripheral neuropathy or neurological deficit ( Based on history of neurological disease and Clinical Neurological assessment- Fine Touch, Pin Test, Motor power)
10. Concurrent chronic analgesic therapy
11. Known hepatic or renal insufficiency( Deranged LFT, SGOT, SGPT, Serum Creatinine, Blood Urea)
12. Field block failure. failure. |
|
|
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 |
| To compare the duration of analgesia produced in all three groups. |
VAS Score analysis,blood pressure and heart rate before the procedure ,at the time of procedure and then every five minutes after the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Onset of sensory block in minutes after the completion of block
2)Onset of motor block in minutes after the completion of block
3)Duration of motor block in hours until return of motor power
3)Haemodynamic parameters (heart rate, blood pressure,spo2) |
VAS Score analysis,blood pressure and heart rate before the procedure ,at the time of procedure and then every five minutes after the procedure. |
|
|
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)
|
24/08/2020 |
| 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="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
|
We will compare the efficacy of ropivacaine and three other adjuvants drugs in ultrasound guided supraclavicular brachial plexus block in upper limp orthopaedic surgeries. |