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

Phase 4

Completed

• Conditions: Labour pain in ASA grade I and II parturients

• Registration Number: CTRI/2014/12/005335
• Lead Sponsor: Lokmanya tilak municipal medical college and general hospital

Brief Summary

This is a randomized double blind parallel group study comparing the efficacy of 0.1% Bupivacaine hydrochloride with fentanyl and 0.1% Ropivacaine hydrochloride with fentanyl in extradural labour analgesia using intermittent top up doses, in 60 ASA grade I and II labouring parturients ,conducted in India.The primary outcome measures are quality of analgesia assesd by VAS score,incidence of motor  blockade assessed by bromage score ,sensory block,requirement of Bupivacaine and Ropivacaine and Fentanyl,obstetric interventions. Secondary  outcome measures are maternal haemodynamic stability,duration of labour,onset of analgesia,incidense of side effects,cost effectiveness.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-12
• Last Update Posted: 2014-12-13

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 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

• Unwilling mother 2.
• B.M.I. more than 30 4.
• Parturient‘s height < 150cm 5.
• Age <18 years 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain relief on Visual analogue score 0 to 10	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.
Motor block assesed by Bromage score	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.
Dose requirement of Bupivacaine and Ropivacaine and Fentanyl	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.
Incidence of Instrumental deliveries.	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 Outcome Measures

Name	Time	Method
Maternal Haemodynamic stability	Neonatal outcome assessed by Virginia Apgar score

Trial Locations

Locations (1)

Lokmanya Tilak Munipal general hospital Ward 12 labour ward under department of Anaesthesia; 🇮🇳 Mumbai, MAHARASHTRA, India

Lokmanya Tilak Munipal general hospital Ward 12 labour ward under department of Anaesthesia

🇮🇳Mumbai, MAHARASHTRA, India

Kishori Bawdane

Principal investigator

9833677290

kishabaw@gmail.com