A study for comparing two techniques to control pain during labour.
Phase 4
Completed
- Conditions
- Health Condition 1: null- American Society of Anaesthesiologists (ASA) grade I and IIHealth Condition 2: O80- Encounter for full-term uncomplicated delivery
- Registration Number
- CTRI/2018/03/012384
- Lead Sponsor
- Government Medical College and Hospital Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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 <= 5 cm)
Baseline pain score > 30 (on a 0-100 VAS)
Able to use PCEA pump
Requesting epidural analgesia for labour
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Maternal satisfaction <br/ ><br>Pain score (VAS) <br/ ><br>Sensory and motor block characterstics <br/ ><br>Haemodynamic parameters of mother foetal heart rate <br/ ><br>Duration of second stage of labour <br/ ><br>Mode of delivery <br/ ><br>Apgar score <br/ ><br>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 <br/ ><br>VAS assessed and recorded at every 5,10,15,20,30,40,50,60 min.then every 1 hour until delivery <br/ ><br>Time of onset of analgesia(VAS 30) <br/ ><br>Time of onset of sensory block(min) <br/ ><br>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 <br/ ><br>Apgar score at 1 and 5 mins will also be recorded <br/ ><br>