| CTRI Number |
CTRI/2025/09/094029 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of two different doses of morphine given by epidural catheter for pain relief after normal vaginal delivery. |
|
Scientific Title of Study
|
A Comparative Evaluation Analgesic Efficacy and Side Effect Profile of 1 mg vs 2 mg Epidural Morphine for Post-Vaginal Delivery Analgesia: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Sapra |
| Designation |
Prof and HOD |
| Affiliation |
Dept of Anaesthesiology and Critical Care, AFMC, Pune |
| Address |
Dept of Anaesthesiology and Critical Care AFMC
Wanowarie Pune- 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
8197084270 |
| Fax |
|
| Email |
adityasapra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akash Ray Mohapatra |
| Designation |
Clinical Tutor |
| Affiliation |
Dept of Anaesthesiology and Critical Care, AFMC, Pune |
| Address |
Dept of Anaesthesiology and Critical Care AFMC
Wanowarie Pune- 411040
Wanowarie Pune- 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
7276632896 |
| Fax |
|
| Email |
araymohapatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANISH KRISHNA G |
| Designation |
Junior Resident |
| Affiliation |
Dept of Anaesthesiology and Critical Care, AFMC, Pune |
| Address |
Dept of Anaesthesiology and Critical Care AFMC
Wanowarie Pune- 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
7907773692 |
| Fax |
|
| Email |
anishkrishnag@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesiology and Critical Care AFMC, Pune , Maharashtra.
PIN -411040 |
|
|
Primary Sponsor
|
| Name |
Dept of Anaesthesiology |
| Address |
Dept of Anaesthesiology and Critical Care AFMC
Wanowarie Pune- 411040 |
| 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 |
| DrAkash Ray Mohapatra |
Dept of Anaesthesiology and Critical Care AFMC Pune |
Dept of Anaesthesiology and Critical Care AFMC Pune
Sholapur road Pune 411040
Pune
MAHARASHTRA |
7276632896
araymohapatra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AFMC PUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O759||Complication of labor and delivery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1 mg morphine |
1 mg morphine in 6 mL saline via epidural catheter Single dose will be given prior to removal of epidural catheter |
| Comparator Agent |
2 mg morphine |
2 mg morphine in 6 mL saline via epidural catheter Single dose will be given prior to removal of epidural catheter |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 19–45 years
Singleton term pregnancy (more than or equal to 37 weeks)
Vaginal delivery with labour epidural analgesia
Able to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Known allergy to morphine or opioids
History of chronic pain or opioid use
Severe obstetric complications (eg PPH requiring transfusion)
Emergency caesarean section delivery
Denied consent for postpartum epidural morphine
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Requirement of rescue analgesia within 24 hours of epidural morphine administration |
Requirement of rescue analgesia within 24 hours of epidural morphine administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of side effects |
within 24 hours |
| Time to first rescue analgesia |
within 24 hours |
| VAS pain scores |
6 and 12 and 24 hours post epidural morphine administration |
| Patient satisfaction score (0–10 scale) |
AT 24 hours |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
10/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This randomized controlled trial
aims to bridge this knowledge gap by evaluating whether reducing the dose from 2 mg to 1 mg maintains
analgesic efficacy while diminishing the side effects profile. The findings are
expected to inform future practice by guiding optimal dosing strategies and supporting the development of evidence-based postpartum analgesia protocols and potentially expanding the scope of neuraxial opioid use beyond caesarean
deliveries. Ultimately this study seeks to balance effective pain relief with
safety and patient satisfaction and helping refine postpartum pain management in
alignment with contemporary guidelines and individualized care models. |