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To compare the pain relief during labour using a epidural local anaesthetic and an opioid versus epidural local anaesthetic and opioid along with intravenous steroid(dexamethasone)

Intravenous dexamethasone as an adjunct to patient-controlled epidural analgesia with levobupivacaine and fentanyl in labour: a randomized, double blind, placebo controlled study - None

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/05/004596
Enrollment
80
Registered
2014-05-13
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

Health Condition 1: null- Age 18 years Primigravida Single gestation Cephalic presentation at â?¥ 36 wk of gestation In early spontaneous labour (cervical dilation â?¤ 5 cm) Baseline pain score 30 (on a 0-100 VAS)

Interventions

Intervention1: Steroid group: This group will receive dexamethasone 8mg intravenously diluted to 50 ml with normal saline 45 minutes before insertion of epidural catheter and will receive 10 ml of lev

Sponsors

GMCH chandigarh
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 >= 36 wk of gestation • In early spontaneous labour (cervical dilation • Baseline pain score > 30 (on a 0-100 VAS) • Able to use PCEA pump • Requesting epidural analgesia for labour

Exclusion criteria

Exclusion criteria: • Refusal by parturient. • Parturients who had received parenteral opioids in the last 4 hours. • Systemic and local sepsis. • Deranged coagulation profile. • Parturients having multiple pregnancies and premature labour. • Obstetric complications (e.g., premature rupture of amniotic membranes). • Noncephalic presentations. • Allergy to study drugs, i.e. levobupivacaine and fentanyl. • H/O peptic ulcer disease. • Known case of uncontrolled Diabetes Mellitus. • Patient who have received dexamethasone in last 7 days for foetal lung maturity.

Design outcomes

Primary

MeasureTime frame
Hourly average consumption of levobupivacaine and fentanyl mixture, including both continuous background infusion plus bolus doses (in ml) corrected for the duration of labour.Timepoint: At the end of delivery

Secondary

MeasureTime frame
Apgar scoreTimepoint: 1 and 5 minute after delivery;Foetal heart rateTimepoint: Continuous foetal heart rate monitoring.;Haemodynamic parameters of motherTimepoint: 5 min for the first 20 min and then every 1 h until delivery;Maternal satisfaction and Pain score (VAS) Timepoint: Every 5 min for the first 20 min and then every 1 h until delivery, on a 0-100 scale.;Sensory and motor block characteristicsTimepoint: Sensory block at midline every 5 min for the first 20 min and then every 1 h until delivery. Lower limb motor block every 5 min using the modified Bromage scale

Countries

India

Contacts

Public ContactDr Pratibha dube

GMCH chandigarh

drsmitra12@yahoo.com9646121521

Outcome results

None listed

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