| CTRI Number |
CTRI/2024/12/078735 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare drug having pain relieving action given via regional method after block in patients undergoing forearm surgeries |
|
Scientific Title of Study
|
A study to compare the efficacy of dexmedetomidine and fentanyl as adjuvants to ropivacaine in USG guided axillary block for upper limb 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 |
Dipti |
| Designation |
Junior Resident, Department of Anesthesiology |
| Affiliation |
Dr.D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anesthesia ,5th floor, Hi tech building Dr.D.Y.Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar,Pimpri-Chinchwad
Department of Anesthesia ,5th floor, Hi tech building Dr.D.Y.Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar,Pimpri-Chinchwad
Pune
MAHARASHTRA
411018
India |
| Phone |
09548578314 |
| Fax |
|
| Email |
drdiptirana06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dipti |
| Designation |
Junior Resident, Department of Anesthesiology |
| Affiliation |
Dr.D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anesthesia ,5th floor, Hi tech building Dr.D.Y.Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar,Pimpri-Chinchwad
Department of Anesthesia ,5th floor, Hi tech building Dr.D.Y.Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar,Pimpri-Chinchwad
Pune
MAHARASHTRA
411018
India |
| Phone |
09548578314 |
| Fax |
|
| Email |
drdiptirana06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dipti |
| Designation |
Junior Resident, Department of Anesthesiology |
| Affiliation |
Dr.D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anesthesia ,5th floor, Hi tech building Dr.D.Y.Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar,Pimpri-Chinchwad
Department of Anesthesia ,5th floor, Hi tech building Dr.D.Y.Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar,Pimpri-Chinchwad
Pune
MAHARASHTRA
411018
India |
| Phone |
09548578314 |
| Fax |
|
| Email |
drdiptirana06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy 5th floor ,Hi-tech building , Dr D Y Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar,Pimpri, pune, Maharashtra,India Pincode-411018 |
|
|
Primary Sponsor
|
| Name |
Dipti |
| Address |
Department of Anesthesia ,5th floor, Hi tech building Dr.D.Y.Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar,Pimpri-Chinchwad |
| 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 Shilpa Sarang Kore |
Dr.D.Y.Patil Medical College, Hospital and Research Centre |
Department of Anesthesia ,5th floor, Hi tech building Dr.D.Y.Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar,Pimpri-Chinchwad
Pune
MAHARASHTRA |
09548578314
Shilpasale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr D Y Patil medical college and research centreInstitutional Ethics Sub -Committee |
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 |
Dexmedetomidine |
0.5 mcg/kg dexmedetomidine as an adjuvant to ropivacaine given in axillary block |
| Comparator Agent |
Fentanyl |
0.5mcg/kg fentanyl given in axillary block for the duration of surgery lasting for 4-5 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-ASA 1 and 2 patients
-Patients posted for upper limb surgeries
-Written consent from the concerned patients |
|
| ExclusionCriteria |
| Details |
-ASA3 or more
-Below 18 years and above 60 years
-Patients with major neurological, cardiac, respiratory, metabolic and coagulation abnormalities
-Patients contraindicated for regional technique
-Patient with known allergies to 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 onset and duration of sensory and motor blockade of dexmedetomidine versus fentanyl as an adjuvant to ropivacaine in axillary block in patients undergoing forearm surgeries |
After administering the block, comparison between the two groups of onset and duration of sensory and motor blockade, duration of analgesia will be assessed at baseline, after injection of study drug at 5 mins, 10 mins, 30 mins and 10 mins after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the duration of postoperative analgesia & observe the side effects of dexmedetomidine & fentanyl as an adjuvant to ropivacaine in axillary block in patients undergoing forearm surgeries |
Duration of analgesia will be assessed post surgery once the effects of the block decrease & time of rescue to analgesia will be assessed 2 hours after surgery & hourly until intervention is required |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
10/01/2025 |
| 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="0"
Months="3"
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 , randomised , double blinded comparative study to compare the efficacy of dexmedetomidine and fentanyl as an adjuvants in axillary block in patients undergoing upper limb surgeries
Parameters that will be compared between the two groups will be the onset and duration of action of sensory and motor blockade, duration of analgesia and side effects |