| CTRI Number |
CTRI/2023/08/056823 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
19/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different drugs through epidural for post operative pain control in knee surgeries. |
|
Scientific Title of Study
|
Comparison of efficacy of bupivacaine (0.125%) with fentanyl (0.7 mcg/kg) versus morphine (2mg) through epidural for post operative analgesia in total knee arthroplasty. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka |
| Designation |
Associate Professor |
| Affiliation |
Kempegowda Insitute Of Medical Sciences, Bangalore |
| Address |
A block 4th floor, department of Anaesthesia, kims bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
9844828926 |
| Fax |
|
| Email |
priya1685@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka |
| Designation |
Associate Professor |
| Affiliation |
Kempegowda Insitute Of Medical Sciences, Bangalore |
| Address |
A block 4th floor, department of Anaesthesia, kims bangalore
KARNATAKA
560004
India |
| Phone |
9844828926 |
| Fax |
|
| Email |
priya1685@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Athira Shankar |
| Designation |
post graduate |
| Affiliation |
kempegowda institute of medical science |
| Address |
kims resident quarters, kempegowda institute of medical science, bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
9113922344 |
| Fax |
|
| Email |
athirashankar13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kempegowda Institute of Medical Science |
|
|
Primary Sponsor
|
| Name |
kempegowda institute of medical science |
| Address |
KR road, parvathipuram, vishveshwarapura, bengaluru, karnataka |
| Type of Sponsor |
Private 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 |
| Dr Priyanka S |
Kempegowda Institute Of Medical Sciences |
A block, 4th floor, Department of Anaesthesia,Major OT complex,Kempegowda Institute Of Medical Science
Bangalore
KARNATAKA |
9844828926
priya1685@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M131||Monoarthritis, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.125% BUPIVACAINE WITH 0.7 MCG/ KG FENTANYL |
0.125% bupivacaine with 0.7 mcg/kg fentanyl amounting to total volume of 6 ml will administered through epidural route for post op analgesia every 6th hourly for 24 hours. |
| Comparator Agent |
Morphine 2 mg |
Morphine 2mg diluted to total of 6 ml will be administered only once through epidural route for post op analgesia for a duration of 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 60 years posted for elective total knee arthroplasty under combined spinal epidural.
American Society of Anaesthesiology (ASA) physical status 1 and 2.
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
a) Patient refusal for the study.
b) Has any known allergy or contraindication to the drugs or neuraxial anaesthesia.
c) Has received chronic opioids.
d) Has uncontrolled diabetic mellitus,hepatic or renal impairment
e) Pregnant or lactating.
f) Duration of surgery extending to more than 4 hours.
g) Local infection at site of injection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare & determine the postoperative analgesic efficacy of bupivacaine 0.125 % with fentanyl versus morphine 2 mg through epidural in tka cases |
4th hourly for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to estimate number of rescue analgesia required
to study the side effects of drugs when administered through epidural |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
12/09/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
International association for the study of pain (IASP) defines pain as "An unpleasent sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage".Ineffectively managing pain in the postoperative period often leads to unpleasent consequences like increased cost of care, slower recovery, development of chronic pain.Postoperative pain relief can be achieved by a number of techniques such as intravenous patient controlled analgesia with Opioids,NSAIDS, peripheral local anaesthetics and epidural analgesia. Neuraxial anesthesia includes all the central blocks - spinal, epidural, and caudal spaces. While it is an invaluable adjunct , it is now even occasionally a good alternative to general anesthesia. Knowledge about the drug used for the epidural block becomes primarily important because it affects duration, desire to have a sensory and/or motor block etc.Epidural administration of local anesthetics and opiates has proven to be effective in the treatment of intra and postoperative pain .Hence, in this sudy we will compare and determine the postoperative analgesic efficacy of bupivacaine 0.125% with fentanyl 0.7mcg/kg versus morphine 2mg through epidural in total knee arthroplasty cases. |