| CTRI Number |
CTRI/2023/06/053534 [Registered on: 05/06/2023] Trial Registered Prospectively |
| Last Modified On: |
05/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on the Comparison of Effects in Lower Body Surgeries using A Local Anesthetic with two different Adjuvants |
|
Scientific Title of Study
|
Comparative study of epidural dexmedetomidine and buprenorphine as adjuvant to Ropivacaine in lower limb orthopaedic surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aswin M S |
| Designation |
Resident, Dept. of Anaesthesiology |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Dept. of Anaesthesiology, Gulbarga institute of medical sciences, Veeresh Nagar cross, Sedam Road, Near MRMC, Kalaburagi.
Gulbarga
KARNATAKA
585105
India |
| Phone |
9539059561 |
| Fax |
|
| Email |
thegr8ams@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagadish M B |
| Designation |
Head of the Department, Dept of Anaesthesiology |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Department of Anaesthesiology, Gulbarga institute of medical sciences, Veeresh Nagar cross, Sedam Road, Near MRMC, Kalaburagi
Gulbarga
KARNATAKA
585105
India |
| Phone |
9886287016 |
| Fax |
|
| Email |
drjagadish.mb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAswin M S |
| Designation |
Resident, Dept. of Anaesthesiology |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Dept. of Anaesthesiology, Gulbarga institute of medical sciences, Veeresh Nagar cross, Sedam Road, Near MRMC,
Kalaburagi.
Gulbarga
KARNATAKA
585105
India |
| Phone |
9539059561 |
| Fax |
|
| Email |
thegr8ams@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gulbarga Institute of Medical Sciences, Veeresh Nagar Cross, Sedam Road, Kalaburagi, Karnataka, 585105 |
|
|
Primary Sponsor
|
| Name |
Gulbarga institute of medical sciences |
| Address |
Gulbarga institute of medical sciences
Veeresh Nagar cross
Kalaburagi
585101 |
| 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 |
| Aswin M S |
Gulbarga Institute of Medical Sciences |
Dept. of Anaesthesiology, Gulbarga Institute of Medical Sciences, Veeresh Nagar, Sedam road, Near MRMC, Kalaburagi,585105
Gulbarga
KARNATAKA |
09539059561
thegr8ams@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee GIMS, Kalaburagi |
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 |
Buprenorphine |
To study the effect of 150 microgram Buprenorphine as an adjuvant to 15 ml of 0.75% Ropivacaine in epidural anaesthesia (L3,L4 space)for lower limb orthopaedic surgeries.The effect will be observed for a duration of 3hrs. |
| Intervention |
Dexmedetomidine |
To study the effect of 50 microgram Dexmedetomidine as an adjuvant to 15 ml of 0.75% Ropivacaine in epidural anaesthesia (L3,L4 space)for lower limb orthopaedic surgeries.The effect will be observed for a duration of 3hrs. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists status I and II
Adult patients of age group between 18-60 years
Patients undergoing for elective lower limb Orthopedic surgeries
BMI between 18.5kg/m2 to 29.9kg/m2 |
|
| ExclusionCriteria |
| Details |
Any bleeding disorders and patients on anticoagulants
Neurological and musculoskeletal diseases
Local infection at the epidural site
Allergic history to local anaesthetics in previous surgeries
Pregnant females |
|
|
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 onset and duration of sensory and motor blockade after adding Dexmedetomidine and Buprenorphine as adjuvant to Ropivacaine in epidural anaesthesia for lower limb orthopaedic surgeries.
To compare the duration of analgesia in both the groups. |
Onset of sensory and motor blockade to be assessed every minute after giving the drug.
Duration of sensory and motor blockade to be assessed every 30 minutes after onset of blockade.
Duration of analgesia to be assessed starting 2-3 hours after administration of drug till the patient complaints of pain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the haemodynamic parameters in both groups
2.To study the adverse effects in both groups. |
1.Intraoperative
2.intraoperative and post operative |
|
|
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)
|
05/06/2023 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is mainly aiming to study the efficacy of two different drugs .Here Buprenorphine is already an established drug where as Dexmedetomidine is a newly introduced drug.This is first time that comparison of these two drugs are being used in Epidural anaesthsia for lower limb surgeries.So hoping this study will be helpful for mankind with good outcomes |