| CTRI Number |
CTRI/2019/08/020573 [Registered on: 06/08/2019] Trial Registered Prospectively |
| Last Modified On: |
30/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the pain reliving efficacy of two pain relieving medicines in postsurgery in pain patients coming for lower spine surgeries - due to spinal cord compression |
|
Scientific Title of Study
|
A study comparing the analgesic efficacy of single dose of epidural morphine Vs epidural morphine with ketamine in patients undergoing lumbar laminectomy with or without discectomy - A randomized controlled clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasadkanna |
| Designation |
PG REGISTRAR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE |
| Address |
Department of Anesthesiology
Christian Medical College Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
8903686991 |
| Fax |
|
| Email |
prasadkanna84.pk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramamani M |
| Designation |
Professor |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE |
| Address |
Department of Anesthesiology
Christian Medical College
Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
8903686991 |
| Fax |
|
| Email |
ramamani@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prasadkanna |
| Designation |
PG REGISTRAR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE |
| Address |
Department of Anesthesiology
Christian Medical College
Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
8903686991 |
| Fax |
|
| Email |
prasadkanna84.pk@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTIONAL REVIEW BOARD
MEDICAL RESEARCH SECTION
CHRISTIAN MEDICAL COLLEGE
Internal fluid - major research grant |
|
|
Primary Sponsor
|
| Name |
Institutional Review Board |
| Address |
Institutional review Board
Research Section Office
Christian Medical College Vellore
India |
| 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 |
| PRASADKANNA |
Christian Medical College |
MAIN OR
Department OF Anaesthesia
Christian Medical College VELLORE
Vellore
TAMIL NADU |
8903686991
prasadkanna84.pk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
RCT
|
Epidural Morphine
dose : 3mg - if weight less than 60kg or age above 60 yrs
4mg - if weight above 60kg and age less than 60 yrs |
| Intervention |
RCT |
Epidural Morphine with Ketamine
Epidural Morphine 3mg with Ketamine 30mg if weight less than 60kg or age above 60 yrs
Epidural Morphine 4mg with Ketamine 30mg if weight above 60 kg and age less than 60 yrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I AND II
2. Patients Undergoing Lumbar Laminectomy And Discectomy Surgery
3. Normal Renal Functions
|
|
| ExclusionCriteria |
| Details |
1. ASA III OR IV
2. BMI >40
3. Impaired Renal Function
4. Intraoperative CSF Leak
5. Any Contraindications to Morphine and Ketamine |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time Taken to Receive First Rescue Analgesia |
3 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. NRS score 1-10
2. Total Amount of Rescue Analgesic Consumed: Cumulative opioid Consumption
3. Post OP Haemodynamics : HR , BP , RR , sedation
4. Post OP Complications - Vomiting , Pruritis , urinary retention , Respiratory depression
|
24 Hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2019 |
| Date of Study Completion (India) |
30/04/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
post operative pain is an important factor that affects recovery after surgery , epidural administration of opioids have been proven to be effective in managing post OP pain . epidural administration of NMDA antagonist has been shown to prolong post OP analgesic and reduce opioid induced central centralization of pain , prevent opioid induced hyperalgesia and opioid tolerance . in this study we are comparing administration of epidural morphine and epidural morphine with ketamine to know which provide better analgesia in post OP lumbar laminectomy patients - in terms of time to receive rescue analgesia , total amount of rescue analgesic received . improves NRS scale . |