| CTRI Number |
CTRI/2023/06/053993 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
16/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
It is the study done in lower limb orthopedic surgeries to assess postoperative pain. The study is done to know the efficacy of epidural fentanyl and buprenorphine as an adjuvant to ropivacaine. |
|
Scientific Title of Study
|
A STUDY TO COMPARE EFFICACY OF
EPIDURAL ROPIVACAINE WITH
FENTANYL AND ROPIVACAINE WITH
BUPRENORPHINE FOR POST
OPERATIVE ANALGESIA IN LOWER
LIMB ORTHOPEDIC SURGERIES
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harshita Muralidhar |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
MAHADEVAPPA RAMPURE MEDICAL COLLEGE |
| Address |
Department of Anaesthesiology,
Basweshwar teaching and General hospital,H.K.E. Society’s
Mahadevappa Rampure Medical College,Kalaburagi -585105
Gulbarga
KARNATAKA
585105
India |
| Phone |
9482861478 |
| Fax |
|
| Email |
mharshita16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sontakke Mahananda Ramrao |
| Designation |
Associate Professor |
| Affiliation |
Mahadevappa Rampure medical college |
| Address |
Department of Anaesthesia,
Basaveshwar teaching and general hospital,
Sedam road,
Gulbarga, Karnataka 585105
Department of Anaesthesia,
Basaveshwar teaching and general hospital,
Sedam road,
Gulbarga, Karnataka 585105
Gulbarga
KARNATAKA
585105
India |
| Phone |
9663420776 |
| Fax |
|
| Email |
nandyalnanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harshita Muralidhar |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
MAHADEVAPPA RAMPURE MEDICAL COLLEGE |
| Address |
Department of Anaesthesiology,
Basweshwar teaching and General hospital,H.K.E. Society’s
Mahadevappa Rampure Medical College,Kalaburagi -585105
Gulbarga
KARNATAKA
585105
India |
| Phone |
9482861478 |
| Fax |
|
| Email |
mharshita16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Basweshwar Teaching and General Hospital,Kalaburagi. |
|
|
Primary Sponsor
|
| Name |
Dr Sontakke Mahananda Ramrao |
| Address |
MAHADEVAPPA RAMPURE MEDICAL COLLEGE |
| 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 |
| Harshita Muralidhar |
Basaweshwar teaching and general hospital |
Department of Anaesthesiology,
Basaweshwar teaching and General Hospital,
Kalaburagi
585105
Gulbarga
KARNATAKA |
9482861478
mharshita16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| H.K.E.Society;s,Mahadevappa Rampure Medical College,Institutional Ethics 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 |
| Comparator Agent |
Group A-Ropivacaine with Fentanyl |
Ropivacaine 0.1% 7ml and 30mcg fentanyl is given once in post operative period in epidural space. |
| Comparator Agent |
Group B-Ropivacaine with Buprenorphine |
Ropivacaine 0.1% 7ml with 60mcg buprenorphine is given in post operative period once in epidural space. |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 All patients posted for lower limb orthopedic surgery.
2 Patients who belongs toAmerican Society of Anaesthesiology grade I andII.
3 Age group 18-80 years.
|
|
| ExclusionCriteria |
| Details |
1.Patients on opioid or sedative medication in the week prior to the surgery.
2.Patients with history of alcohol or drug abuse.
3.History of coagulation disorders or on anti coagulant drug.
4.Patients who have known allergies to any of test drugs.
5.Known case of respiratory diseases.
6.Contraindications for epidural anaesthesia.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the efficacy of epidural fentanyl and buprenorphine as an adjuvant to ropivacaine for post operative analgesia.
2.To compare the duration of post operative analgesia for ropivacaine with fentanyl and ropivacaine with buprenorphine.
|
1.To study the efficacy of epidural fentanyl and buprenorphine as an adjuvant to ropivacaine for post operative analgesia at baseline.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study systemic side effects of fentanyl and buprenorphine |
1.To compare the duration of post operative analgesia for ropivacaine with fentanyl and ropivacaine with buprenorphine for 24 hours.
|
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/07/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1.It is a comparative study between epidural ropivacaine with fentanyl and ropivacaine with buprenorphine for post operavtive analgeia in lower limb orthopedic surgeries 2.It is between two groups-Group A and Group B
OBJECTIVES-
1.
To study
the efficacy of epidural fentanyl and buprenorphine as an adjuvant to ropivacaine for post operative analgesia.
2.
To compare
the duration of post operative analgesia for
ropivacaine with fentanyl and ropivacaine with buprenorphine. |