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A clinical trial to compare efficacy of two drugs, Bupivacaine hydrochloride & Ropivacaine hydrochloride for extradural labour analgesia.

A Double blind comparison of combination of 0.1% Ropivacaine & Fentanyl to combination of 0.1% Bupivacaine & Fentanyl for extradural analgesia in labour.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/12/005335
Enrollment
60
Registered
2014-12-30
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: Epiduarl labour analgesia.: Epidural catheter was inserted under strict aseptic precautions when cervical dilatation reached more than 3 cm with active labour The procedure was performe

Sponsors

Lokmanya tilak municipal medical college and general hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA grade I and II parturients 2. Consent for project 3. More than 36 weeks of gestation 4. Single live term fetus with vertex presentation 5. Uncomplicated active labour with cervical dilatation >= 3 cm

Exclusion criteria

Exclusion criteria: 1. Unwilling mother 2. ASA > II 3. B.M.I. more than 30 4. Parturientâ??s height 5. Age 6. Difficult intubation 7. Contraindication for epidural catheter placement 8. Complicated obstetric history 9. Sensitivity to study drug 10. Administration of IV analgesics within 1 hr of epidural request

Design outcomes

Primary

MeasureTime frame
Pain relief on Visual analogue score 0 to 10 Motor block assesed by Bromage score Dose requirement of Bupivacaine and Ropivacaine and Fentanyl Incidence of Instrumental deliveries.Timepoint: Pain score (VAS)and Motor block and requirement of drugs all at the begining of labour and during labour and at the end of labour Instrumental deliveries at the end of labour.

Secondary

MeasureTime frame
Maternal Haemodynamic stability Neonatal outcome assessed by Virginia Apgar score Duration of labour onset of analgesia Incidence of side effects cost effectiveness Timepoint: At the begining of labour and during labour and at the end of labour.

Countries

India

Contacts

Public ContactKISHORI BAWDANE

Lokmanya Tilak Municipal Medical college and general hospital

Jyotimagr@rediffmail.com9833706466

Outcome results

None listed

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