A study for comparing two techniques to control pain during labour.

A study comparing the efficacy of two techniques,PIEB and PCEA on the consumption of epidural levobupivacaine and fentanyl mixture in labouring parturients.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012384

Enrollment

Registered

2018-03-07

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

Health Condition 1: null- American Society of Anaesthesiologists (ASA) grade I and II Health Condition 2: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: group 1: This group will receive PCEA bolus of 5 ml (0.1% levobupivacaine + 2 mcg/ml fentanyl) with 15 min lockout interval with provision of rescue clinician bolus of 5 ml of same drug

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anaesthesiologists (ASA) grade I and II Age >18 years Primigravida Single gestation Cephalic presentation at >= 36 weeks of gestation In early spontaneous labour (cervical dilation Baseline pain score > 30 (on a 0-100 VAS) Able to use PCEA pump Requesting epidural analgesia for labour

Exclusion criteria

Exclusion criteria: refusal by parturient parturients who had received parentral opioids in last 4 hours systemic and local sepsis deranged coagulation profile parturients having multiple pregnancies and premature labour obstetric complications (premature rupture of amniotic membrane,antepartum haemorrhage, eclampsia) chorioamnionitis HELLP syndrome noncephalic presentation allergy to study drugs,i.e.,levobupivacaine and fentanyl

Design outcomes

Primary

Measure	Time frame
Total consumption of levobupivacaine + fentanyl mixture in, PIEB v/s PCEA group,corrected for duration of labour(ml/hr)Timepoint: Heart rate,systolic blood pressure,diastolic blood pressure and spo2 will be continuously monitored and recorded at 5,10,15,20,30,40,50,60 min.and then every 1 hour until delivery.	—

Secondary

Measure	Time frame
Maternal satisfaction Pain score (VAS) Sensory and motor block characterstics Haemodynamic parameters of mother foetal heart rate Duration of second stage of labour Mode of delivery Apgar score Adverse effectsTimepoint: Foetal heart rate will be continuously monitored and recorded at 5,10,15,20,30,40,50,60 min.then every 1 hour until delivery VAS assessed and recorded at every 5,10,15,20,30,40,50,60 min.then every 1 hour until delivery Time of onset of analgesia(VAS 30) Time of onset of sensory block(min) Lower limb motor block every 5 min using modified bromage scale for the first 20 min.then at 60 min then every 1 hour until delivery Apgar score at 1 and 5 mins will also be recorded	—

Measure

Time frame

Maternal satisfaction Pain score (VAS) Sensory and motor block characterstics Haemodynamic parameters of mother foetal heart rate Duration of second stage of labour Mode of delivery Apgar score Adverse effectsTimepoint: Foetal heart rate will be continuously monitored and recorded at 5,10,15,20,30,40,50,60 min.then every 1 hour until delivery VAS assessed and recorded at every 5,10,15,20,30,40,50,60 min.then every 1 hour until delivery Time of onset of analgesia(VAS 30) Time of onset of sensory block(min) Lower limb motor block every 5 min using modified bromage scale for the first 20 min.then at 60 min then every 1 hour until delivery Apgar score at 1 and 5 mins will also be recorded

—

Countries

India

Contacts

Public ContactDr Sukanya Mitra

drsmitra12@yahoo.com9646121521

Outcome results

None listed

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