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to see the effect of epidurally administered dexamethasone on pain relief during labour when used as an additive to local anaesthetic and opioid combination

Efficacy of epidural dexamethasone as an adjunct to levobupivacaine-fentanyl combination for labour analgesia:A randomised double-blind controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/02/005558
Enrollment
60
Registered
2015-02-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: dexamethasone: all the patients will be divided into two groups: one will receive 8mg dexamethasone(preservative free)dissolved in 10ml of 0.9% Normal saline administered epidurally.Thi

Sponsors

Government medical college and hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • American Society of Anesthesiologists (ASA) grade I and II • Age >18 years • Primigravida • Single gestation • Cephalic presentation at >= 37 completed weeks of gestation • In early spontaneous labour (cervical dilation • Baseline pain score > 30 (on a 0-100 Visual analog scale) • Able to use PCEA pump • Requesting epidural analgesia for labour

Exclusion criteria

Exclusion criteria: • Refusal by parturient. • Parturients who had received oral or parenteral analgesics in the last 4 hours. • Systemic and local sepsis. • Deranged coagulation profile. • Preterm labour.( • Obstetric complications (e.g., premature rupture of amniotic membranes). • Foetus with a non re-assuring non-stress test • Foetus with known or suspected congenital abnormalities • Allergy to study drugs, i.e.,levobupivacaine, fentanyl or dexamethasone • Patient with Diabetes (either pre-existing or gestational) or history of immunosuppression • Patient already receiving steroids

Design outcomes

Primary

MeasureTime frame
Hourly total consumption of levobupivacaine + fentanyl mixture, including both continuous background infusion plus bolus doses (in ml) till deliveryTimepoint: till the delivery of baby

Secondary

MeasureTime frame
Maternal satisfaction (VAS) Pain score (VAS) Sensory and motor block characteristics Haemodynamic parameters of mother Foetal heart rate Duration of second stage of labour Mode of delivery Apgar scores Adverse effectsTimepoint: till the delivery of baby

Countries

India

Contacts

Public ContactAnkur Dhal

Government Medical college and hospital

drsmitra12@yahoo.com9646121521

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026