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Oral paracetamol as an adjunct to labour epidural analgesia

Efficacy of oral paracetamol for sparing the dosage of levobupivacaine-fentanyl combination in patient-controlled combined spinal-epidural analgesia in labouring parturients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/02/007963
Enrollment
60
Registered
2017-02-27
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: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: Group 1-combined spinal epidural with oral paracetamol group: Parturients will receive 1 gram oral paracetamol 45 mins before combined spinal- epidural block Control Intervention1: Grou

Sponsors

Government Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)ASA Grade 1 and 2 2)Age more than 18 years 3)Primigravida Single gestation 4)Cephalic presentation at 36 completed weeks of gestation 5)In early spontaneous labour(cervical dilatation 6)Baseline pain score > 30(on a 0-100 VAS) 7)Able to use PCEA pump 8)Requesting epidural analgesia for labour

Exclusion criteria

Exclusion criteria: 1)Refusal by parturient 2)Parturients who had received parenteral opiods in the last 4 hours 3)Systemic and local sepsis 4)Deranged coagulation profile 5)Parturients having multiple pregnancies and premature labour 6)Obstetrics complications(eg. PROM) Chorioamnionitis 7)Patients with hepatic and renal impairment 8)Unable to swallow oral tablets 9)HELLP syndrome 10)Noncephalic presentations 11)Allgery to study drugs i.e levobupivacaine,fentanyl,paracetamol

Design outcomes

Primary

MeasureTime frame
Hourly total consumption of levobupivacaine + fentanyl mixture, including both continous background infusion plus bolus doses(in ml) starting from 1 hour after ingestion of paracetamol or placebo, for duration of labourTimepoint: Till delivery of baby

Secondary

MeasureTime frame
Maternal satisfaction(VAS) Pain score(VAS) Sensory and motor block characteristics Hemodynamic parameters of mother Foetal heart rate Duration of second stage of labour Mode of delivery Apgar scores Adverse effectsTimepoint: Till delivery of baby

Countries

India

Contacts

Public ContactDr Reecha

Government College and Hospital Chandigarh

drsmitra12@yahoo.com9646121521

Outcome results

None listed

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