Acomparative study on effect of levobupivacaine versus ropivacaine with fentanyl as add on for patient controlled epidural labour analgesia.

Not yet recruiting

• Conditions: Pregnancy, childbirth and the puerperium,

• Registration Number: CTRI/2021/03/032404
• Lead Sponsor: Dr Jaya Lalwani

Brief Summary

This is interventional randomised study to compare the effect of levobupivacaine  and ropivacaine with fentanyl as an adjuvant for patient control epidural labour analgesia in parturient with ASA  grade II physical state. It will be conducted in single center in India. The primary outcome measure will be total dose requirement of levobupivacaine and ropivacaine with fentanyl and secondary outcomes will be total number of PCEA  demand boluses, total number of manual rescue boluses, extent of sensory block, maternal satisfaction score, mode of delivery, fetal outcome, side effects like hypotension, nausea, vomiting, pruritis , motor blockade.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-03-26
• Study Start: 2021-03-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• ASA physical status II 2.Parturients with cervical dilation <5 cm 3.Nulliparous labouring parturients with singleton pregnancy and vertex presentation who will request labour analgesia.
• Non stress test of foetus should be normal.

Exclusion Criteria

• Any contraindication to neuraxial block like Patient reusal or uncooperative patient Coagulopathy History of allergy to study drugs Skin infection in lumbar region.
• Patients who had received parenteral opiods <2 hour earlier 3.
• Parturients with obsterics complications such as multiple pregnancies, prologed labour, PIH,Gestational diabetes, Oligohydromnios, Polyhydromnios, Bad obstetrics history, foetus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total dose requirement of levobupivacaine and ropivacaine with fentanyl as an adjuvant	Hemodynamic parameters every 5 minute till 30 minute and every 15 minutes till delivery of fetus

Secondary Outcome Measures

Name	Time	Method
1. Total number of PCEA demand bolus	2.Total number of manual rescue boluses

Trial Locations

Locations (1)

DR BHIMRAO AMBEDKAR MEMORIAL HOSPITAL RAIPUR; 🇮🇳 Raipur, CHHATTISGARH, India

DR BHIMRAO AMBEDKAR MEMORIAL HOSPITAL RAIPUR

🇮🇳Raipur, CHHATTISGARH, India

DR MRINALINI VERMA

Principal investigator

9770778764

Mrinaliniverma34@yahoo.com