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To compare the pain relief during labour using a epidural three concentration of local anaesthetic and opoid.

â?? OPTIMAL CONCENTRATION OF LEVOBUPIVACAINE IN LABOUR PAIN MANAGEMENT USING PARTURIENT CONTROLLED EPIDURAL ANALGESIA (PCEA)â?? a Double-blind, Randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025870
Enrollment
33
Registered
2020-06-15
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: GroupI-LI-Levobupivacaine 0.0625 : These group receive Levobupivacaine+Fentanyl(2mcg/ml)-intial dose (8ml)+background infusion(8mg/ml)+PCEA bolus(2ml)+/-rescue bolus(5ml) Control Interv

Sponsors

Dr S N Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) American Society of Anesthesiologists (ASA) grade I and II 2) Age >18 years 3) Primigravida 4) Single gestation 5) Cephalic presentation at > 37 wk of gestation 6)In early spontaneous labour (cervical dilation 50% effacement 7) Requesting epidural analgesia for labour

Exclusion criteria

Exclusion criteria: 1)Refusal by parturient. 2) Systemic and local sepsis. 3)Deranged coagulation profile. 4)Parturients having multiple pregnancies and premature labour. 5)Obstetric complications (e.g., premature rupture of amniotic membranes). 6)Allergy to study drugs, i.e. levobupivacaine and fentanyl. 7)Body mass index >35mg/m2

Design outcomes

Primary

MeasureTime frame
Hourly (total dose )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
Maternal satisfaction and Pain score (VAS) Haemodynamic parameters Sensory block Lower limb motor block( modified Bromage scale) Foetal heart rate- Continuous foetal heart rate monitoring. Apgar scoreTimepoint: every 5 min for first 30 min then next 30 min then 60 min next hours until delivery. Apgar score-1min and 5 min

Countries

India

Contacts

Public ContactDr Hemlata yadav

Department of Anaesthesiology and Critical care Dr. S.N.Medical College Jodhpur

sarita.janweja@gmail.com9829116420

Outcome results

None listed

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