| CTRI Number |
CTRI/2025/09/094676 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing pain relief and safety of epidural morphine alone versus epidural morphine with dexamethasone after lower abdominal surgeries. |
|
Scientific Title of Study
|
A Comparison of Safety and Effectiveness of Epidural Morphine Versus Epidural Morphine with Dexamethasone for Post Operative Analgesia in Infraumbilical Surgeries |
| 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 Santhosh M C B |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Mandya Institute of Medical Sciences Mandya
Department of Anaesthesiology Mandya Institute of Medical Sciences Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9886811263 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhosh M C B |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Mandya Institute of Medical Sciences Mandya
Department of Anaesthesiology Mandya Institute of Medical Sciences Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9886811263 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santhosh M C B |
| Designation |
Associate professor |
| Affiliation |
Mandya Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Mandya Institute of Medical Sciences Mandya
Department of Anaesthesiology Mandya Institute of Medical Sciences Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9886811263 |
| Fax |
|
| Email |
mcbsanthu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Mandya Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Santhosh M C B |
| Address |
Associate Professor Department of Anaesthesiology Mandya Institute of Medical Sciences Mandya |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Lakshmilal U R |
Post graduate student Department of Anaesthesiology Mandya Institute of Medical Sciences Mandya |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lakshmilal U R |
Mandya Institute of Medical Sciences |
major OT Department of Anaesthesiology Mandya Institute of Medical Sciences Mandya
Mandya
KARNATAKA |
9633397068
lakshmilaluttoly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution 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 |
| Intervention |
morphine |
patient will be given epidural topup with 1mg morphine diluted to 10ml with normal saline |
| Comparator Agent |
morphine with dexamethasone |
patient will be given epidural topup with combination of 0.5mg morphine and 4mg dexamethasone diluted to 10ml with normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society Of Anaesthesiologist grade I and II
Patients willing to give informed consent |
|
| ExclusionCriteria |
| Details |
Pregnant women
patients with history of long term use of corticosteroids or any analgesics
patients with history of allergy to study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative analgesia between epidural morphine versus combination of epidural morphine with dexamethasone among patients undergoing infraumbilical surgeries |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare adverse effects and hemodynamic changes between two groups |
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 4 |
|
Date of First Enrollment (India)
|
25/09/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Epidural morphine provides effective pain relief and patient satisfaction following major surgeries. It acts by binding to opioid receptors in the spinal cord, thereby reducing transmission of pain signals. However adverse effects of opioids such as pruritis, nausea, vomiting, urinary retention are non-fatal but troublesome whereas delayed respiratory depression especially with higher doses of epidural morphine (>2 mg) can be a serious side effect. Dexamethasone is a long-acting corticosteroid improves quality of sensory block in peripheral nerve blocks and epidural anaesthesia. The mechanism of action is by decreasing inflammation, delaying impulses in C-fibers, and stopping the ectopic discharges of the nerves, thus enhances the duration of analgesia with opioid sparing and antiemetic effects. This study has been designed to evaluate the usefulness of 1mg morphine versus combination of 0.5mg morphine and 4mgdexamethasone in providing postoperative analgesia with respect to duration and quality of analgesia. |