| CTRI Number |
CTRI/2019/08/020706 [Registered on: 14/08/2019] Trial Registered Prospectively |
| Last Modified On: |
13/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparative study of adjuvant to epidural bupivacaine for post operative pain relief in adult patients undergoing total knee replacement |
|
Scientific Title of Study
|
Comparative study of dexmedetomidine and fentanyl as an adjuvant to epidural bupivacaine for post operative pain relief in adult patients undergoing total knee replacement:A Randomized Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sana Naseem |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Nehru Medical College AMU Aligarh |
| Address |
Department of anaesthesiology and critical care
Jawaharlal Nehru Medical College Hospital
AMU Aligarh
Department of anaesthesiology and critical care
Jawaharlal Nehru Medical College Hospital
AMU Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9105399786 |
| Fax |
|
| Email |
drsana2301@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abu Nadeem |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College AMU Aligarh |
| Address |
Department of anaesthesiology and critical care
Jawaharlal Nehru Medical College Hospital
AMU Aligarh
Department of anaesthesiology and critical care
Jawaharlal Nehru Medical College Hospital
AMU Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837757772 |
| Fax |
|
| Email |
drabunadeem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sana Naseem |
| Designation |
junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College AMU Aligarh |
| Address |
Department of anaesthesiology and critical care
Jawaharlal Nehru Medical College Hospital
AMU Aligarh
Department of anaesthesiology and critical care
Jawaharlal Nehru Medical College Hospital
AMU Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9105399786 |
| Fax |
|
| Email |
drsana2301@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College AMU Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical College Aligarh Muslim University, Aligarh |
| 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 |
| Sana Naseem |
Jawaharlal Nehru Medical College AMU Aligarh |
Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical College Aligarh Muslim University
Aligarh
UTTAR PRADESH
Aligarh
UTTAR PRADESH |
9105399786
drsana2301@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Faculty of Medicine, AMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
study of dexmedetomidine as a adjuvant in epidural anaesthesia for postoperative pain relief in adult patients undergoing total knee replacement
Inj .5% Bupivacaine plain 10ml + Inj dexmedetomidine 0.5ug/kg
One year
|
| Comparator Agent |
Fentanyl |
study of fentanyl as a adjuvant in epidural anaesthesia for postoperative pain relief in adult patients undergoing total knee replacement
Inj 0.5% Bupivacaine plain 10 ml + Inj dexmedetomidine 0.5ug/kg
One Year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II patients
Patients undergoing total knee replacement surgeries |
|
| ExclusionCriteria |
| Details |
Patients with mental dysfunction or cognitive deficiency
history of psychiatric illness
Patients with neuro-muscular, vestibular, hepatic or major systemic disease
History of alcohol or drug abuse
History of allergy to local anaesthetics
Patients with any contraindications to epidural anaesthesia
medical conditions affecting balance and coordination |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate and Compare the anaesthetic effects and post-operative pain relief of epidurally administered bupivacaine plus fentanyl with Bupivacaine plus dexmedetimidine |
1yr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate and Compare the anaesthetic effects and post-operative pain relief of epidurally administered bupivacaine plus fentanyl with Bupivacaine plus dexmedetimidine |
1yr |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
20/08/2019 |
| 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
|
NO publication yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Comparison of dexmedetomidine and fentanyl as an adjuvant to epidural bupivacaine for post operative pain relief in adult patients undergoing total knee replacement.To Evaluate and compare the aesthetic effects and post-operative pain relief of epidually administered bupivacaine + fentanyl with bupivacaine + dexmedetomidine.
|