| CTRI Number |
CTRI/2025/07/091316 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study about axillary block using 0.5% ropivacaine in arm and forearm surgeries |
|
Scientific Title of Study
|
Comparison between the efficacy of dexmedetomidine versus magnesium sulphate as adjuvants to 0.5 percent ropivacaine in axillary brachial plexus block in hand and forearm surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratikshya Nath |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr D.Y. Patil Medical college and hospital and Research center |
| Address |
Department of anaesthesia,5th floor hitech building. Dr D.Y.Patil medical college and hospital and research center, sant tukaram nagar , Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9938216298 |
| Fax |
|
| Email |
pratikshyanath14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shilpa Kore |
| Designation |
Assistant Proffessr |
| Affiliation |
Dr D.Y. Patil Medical college and hospital and Research center |
| Address |
Department of anaesthesia,5th floor hitech building. Dr D.Y.Patil medical college and hospital and research center, sant tukaram nagar , Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9767002436 |
| Fax |
|
| Email |
shilpasale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shilpa Kore |
| Designation |
Assistant Proffessr |
| Affiliation |
Dr D.Y. Patil Medical college and hospital and Research center |
| Address |
Department of anaesthesia,5th floor hitech building. Dr D.Y.Patil medical college and hospital and research center, sant tukaram nagar , Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9767002436 |
| Fax |
|
| Email |
shilpasale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor , hitech building. Dr. D.Y. Patil medical college and hospital and research center, sant tukaram nagar, Pimpri, Pune, Maharashtra ,411018 |
|
|
Primary Sponsor
|
| Name |
Pratikshya Nath |
| Address |
Department Of Anaesthesia,5th floor , hitech building. Dr. D.Y. Patil medical college and hospital and research center, sant tukaram nagar, Pimpri, Pune, Maharashtra ,411018 |
| 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 |
| Dr Pratikshya Nath |
Dr D.Y.Patil medical college and hospital and research center |
Dr D.Y.Patil medical college and hospital and research center,Sant Tukaram Nagar, Pimpri, Pune
411018
Pune
MAHARASHTRA |
9938216298
pratikshyanath14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Use of dexmedetomidine in 27PATIENTS– 24ml of 0.5%ropivacaine + 0.5 mcg/kg dexmedetomidine (diluted
with 0.9 % normal saline to 1 ml) in prolonging the duration of axillary block in hand and forearm surgeries |
| Comparator Agent |
Magnesium sulphate |
using magnesium sulphate in 27 PATIENTS–24mlof0.5%ropivacaine + 100 mg mgso4 ( diluted with 0.9%
normal saline to 1ml) comparison to dexmedetomidine as an adjuvant to 0.5% ropivacaine in prolonging the duration of axillary block in hand and forearm surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II patients
Aged between 18-60 years of either sex.
Patients undergoing hand and forearm surgery.
Availability of informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients with ASA physical status III or more.
Patients with below 18 years and above 60 years.
Patients posted for emergency procedures.
Patients with major neurological, cardiac, respiratory, metabolic, renal, hepatic
disease or with coagulation abnormalities.
Patients contraindicated for regional technique.
Patients with known allergies to the local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of dexmedetomidine versus magnesium sulphate as adjuvants to 0.5% ropivacaine in axillary brachial plexus block in hand and forearm surgeries |
The effects of the block needs to be assessed at baseline, after drug administration, after 5,10,15,30,45,60,90,120,150,180 minutes and at the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of dexmedetomidine versus magnesium sulphate as adjuvants to 0.5% ropivacaine in axillary brachial plexus block in hand & forearm surgeries on the basis of duration of block, bromage scale, VAS score & requirement of any postop analgesia |
To assess the duration of analgesia post surgery with the help of VAS score system every 2 hourly till 24 hours post surgery |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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)
|
01/08/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a prospective , randomized, double blinded comparative study to camparethe efficacy of dexmedetomidine versus magnesium sulphate as adjuvants to 0.5% ropivacaine in axillary brachial plexus block in hand and forearm surgeries.
The parameters that need to be studied are the onset and duration of motor and sensory blockade and the time at which rescue analgesia is required. |