CTRI/2026/02/104560Not yet recruitingPhase 4
Comparison of spinal versus combined spinal-epidural anaesthesia on the incidence of postpartum blues in patients undergoing caesarean delivery: a randomized controlled trial
AIIMS New Delhi1 site in 1 country120 target enrollmentStarted: March 11, 2026Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Incidence of maternal blues on POD-3 using Edinburgh Postnatal Depression Scale (EPDS) in women undergoing caesarean deliveries under SA versus CSE
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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).
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Incidence of maternal blues on POD-3 using Edinburgh Postnatal Depression Scale (EPDS) in women undergoing caesarean deliveries under SA versus CSE
Time Frame: Assessed on post operative day 3
Secondary Outcomes
- 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
- Post-operative pain scores in both groups using NRS score(Assessed at 6 hours, 24 hours, 48 hours, 72 hours after surgery)
Investigators
Amal Razik
AIIMS New Delhi
Study Sites (1)
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