| CTRI Number |
CTRI/2022/07/044420 [Registered on: 28/07/2022] Trial Registered Prospectively |
| Last Modified On: |
27/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
predicting efficiancy of ropivacaine with fentanyl and magnesium sulphate through intravenous regional anaesthesia for all hand surgeries |
|
Scientific Title of Study
|
Comparison of Magnesium Sulphate and Fentanyl as an Adjuvant to Ropivacaine in Intravenous Regional Anaesthesia for Upper Extremity Surgeries-A Prospective Randomised Double Blind Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ratthinam PL |
| Designation |
post graduate |
| Affiliation |
Krishna institute of medical sciences,deemed to be university |
| Address |
Department of Anaesthesiology,
Krishna institute of medical sciences "Deemed to be university" Karad,
satara,Maharashtra,415539
Satara
MAHARASHTRA
415539
India |
| Phone |
9688416931 |
| Fax |
|
| Email |
rathna1palaniappan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Naseema V Kanase |
| Designation |
professor |
| Affiliation |
Krishna Institute of Medical Science Deemed To be University |
| Address |
Department of Anaesthesiology,
Krishna institute of medical sciences "Deemed to be university" Karad,
satara,Maharashtra,415539
Satara
MAHARASHTRA
415539
India |
| Phone |
|
| Fax |
|
| Email |
naseemakanase@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Naseema v kanase |
| Designation |
Professor |
| Affiliation |
Krishna Institute of Medical Science Deemed To be University |
| Address |
Krishna institute of medical sciences "Deemed to be university" Karad,
satara,Maharashtra,415539
Satara
MAHARASHTRA
415539
India |
| Phone |
|
| Fax |
|
| Email |
Naseemakanase@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Krishna Institute of medical sciences Deemed To Be University |
|
|
Primary Sponsor
|
| Name |
Krishna Institute of medical sciences Deemed To Be University |
| Address |
Department of Anaesthesiology,Krishna Institute of medical sciences "Deemed To Be University" Malkapur,Karad |
| Type of Sponsor |
Other [(Deemed To Be University)] |
|
|
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 |
| Naseema v kanase |
Krishna Institute of Medical Sciences |
Department of Anaesthesiology,
satara,
Maharashtra
Satara
MAHARASHTRA |
9688416931
Naseemakanase@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Krishna Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S698||Other specified injuries of wrist,hand and finger(s), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
fentanyl |
group RF: patients receiving fentanyl 50mcgs along with 0.2%ropivacaine as Intra venous regional anaesthesia to assess sensory and motor blockade and time to first analgesia |
| Comparator Agent |
magnesium sulphate |
group RM: magnesium sulphate 30mg/kg along with ropivacaine 0.2% and onset of sensory & motor blockade ,time to first nalgesia noted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient with ASA physical status 1 & 2
Age from 18yrs to 60 yrs |
|
| ExclusionCriteria |
| Details |
1.known allergies to the drugs used.
2.patient belonging to ASA 3 & above
3.Patients with a history of any Cardiovascular, respiratory, or central nervous
system disorder
4.Patients with hematological disorders such as sickle cell anemia and
thalassemia.
5.patient with difficult airway. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the onset and duration of motor & sensory blockade
2.To assess time to first postoperative analgesic requirement. |
from the time of drug injection to pin prick sensation checked at six separate areas
inability to move fingers and elbow in supine position after drug injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess time to first postoperative analgesic requirement.
recovery from sensory and motor block |
time elapsed from torniquet release to recovery of sensations in dermatomes which was determined by pin prick |
|
|
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)
|
30/07/2022 |
| 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="2"
Months="0"
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
|
Regional anaesthesia may provide an ideal and safe operative condition when used
optimally. It is said to cause the least interference with the vital physiological
functions of the body with reduced stress response, avoids polypharmacy and
provides an alert, awake and co-operative patient when compared to conventional
methods.
The adequately administered regional anaesthesia provides excellent
intraoperative pain control and also good relief of postoperative pain & regional
blocks are less stressful for the patients.Intravenous regional anesthesia (IVRA) is used in Outpatient hand surgery as an
easily applicable and cost-effective technique with clinical advantages and it is an
ideal anesthetic method particularly for short lasting procedures.Ropivacaine may serve
as local anaesthetic for IVRA that could provide prolonged and improved analgesia
over lidocaine and have lower toxicity profile when compared with bupivacaine. In
an attempt to reduce tourniquet discomfort and pain and to improve the
postoperative analgesia, adjuvants could be added. It is giving good analgesia and adequate muscle relaxation. Provides bloodless operative field. Widely applicable to patients of different ages and physical status. |