| CTRI Number |
CTRI/2026/02/104560 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study of presence of a common mood disorder after cesarean delivery in mothers receiving anesthesia inform of spinal injection along with a port kept in back which can be used or pain relief or without it. |
|
Scientific Title of Study
|
Comparison of spinal versus combined spinal-epidural anaesthesia on the incidence of postpartum blues in patients undergoing caesarean delivery: a randomized controlled 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 |
Amal Razik |
| Designation |
Junior Resident (Academic) |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Anaesthesiology,
Pain medicine and critical care,
Room number 5011 teaching block
AIIMS New Delhi
South
DELHI
110049
India |
| Phone |
09650149705 |
| Fax |
|
| Email |
amalrazik123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Choro Athiphro Kayina |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Anaesthesiology,
Pain medicine and critical care,
Room number 5011 teaching block
AIIMS New Delhi
South
DELHI
110049
India |
| Phone |
9654116228 |
| Fax |
|
| Email |
kayinaathiphro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Choro Athiphro Kayina |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of Anaesthesiology,
Pain medicine and critical care,
Room number 5011 teaching block
AIIMS New Delhi
South
DELHI
110049
India |
| Phone |
9654116228 |
| Fax |
|
| Email |
kayinaathiphro@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, South delhi, New Delhi, India
pin -110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
AIIMS New Delhi-110029, India |
| 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 |
| Dr Amal Razik |
Mother and Child Block, AIIMS New Delhi |
Mother and child block, aiims new delhi,
gautam nagar -110049, aiims new delhi
South
DELHI |
09650149705
amalrazik123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F53||Puerperal psychosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Regional Anaesthesia technique |
Combined Spinal epidural anaesthesia
To be placed before surgery and epidural shall be left for pain medication till 3rd day in post op period |
| Comparator Agent |
Regional anaesthesia technique |
Spinal Anaesthesia
to be provided just prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women aged between 18 – 40 years, undergoing caesarean delivery (Category III & IV LSCS)
American Society of Anaesthesiologists (ASA) physical status I–II
Able to understand and complete study questionnaires (e.g. literate in local language)
|
|
| ExclusionCriteria |
| Details |
Pre-existing psychiatric illness or current use of antidepressant or anxiolytic medication
Contraindication to neuraxial anaesthesia (e.g. coagulopathy, infection at puncture site, severe spinal deformity)
Severe obstetric complications (e.g. pre-eclampsia with severe features, eclampsia, HELLP syndrome)
Multiple gestation
Advanced cardiac disease
Unwillingness to receive an epidural cathete (for the CSE group, if randomized) |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of maternal blues on POD-3 using Edinburgh Postnatal Depression Scale (EPDS) in women undergoing caesarean deliveries under SA versus CSE |
Assessed on post operative day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of maternal blues using EPDS between SA and CSE in women undergoing caesarean deliveries |
Assessed on Post operative day 3 |
Incidence of postpartum blues using EDPS score
|
Assessed at 6 weeeks postpartum |
| Post-operative pain scores in both groups using NRS score |
Assessed at 6 hours, 24 hours, 48 hours, 72 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
11/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
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
|
There is a growing need to understand whether optimizing intraoperative and postoperative anesthetic care can influence not only physical recovery but also maternal mental health during the vulnerable puerperium.There are studies on post partum blues but effect of using different models of anesthesia on postpartum blues is not examined until dayby scientific community in Indian population. This study aims to address the lacunae. |