Levobupivacaine versus ropivacaine with fentanyl as an adjuvant for patient controlled epidural labour analgesia- A comparative study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Total dose requirement of levobupivacaine and ropivacaine with fentanyl as an adjuvant
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
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
- •Parturients with obsterics complications such as multiple pregnancies, prologed labour, PIH,Gestational diabetes, Oligohydromnios, Polyhydromnios, Bad obstetrics history, foetus.
Outcomes
Primary Outcomes
Total dose requirement of levobupivacaine and ropivacaine with fentanyl as an adjuvant
Time Frame: Hemodynamic parameters every 5 minute till 30 minute and every 15 minutes till delivery of fetus
Secondary Outcomes
- 1. Total number of PCEA demand bolus(2.Total number of manual rescue boluses)