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Comparison of 2 techniques dural puncture epidural and combined spinal epidural for relieving labour pain during the birthing process in pregnant women

Comparison of analgesic efficacy of Dural Puncture Epidural with Combined Spinal Epidural in labouring parturients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020486
Enrollment
50
Registered
2019-08-01
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: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: 1.dural puncture epidural: The dural puncture epidural (DPE) technique is performed by creating a single dural perforation via a spinal needle placed through the shaft of an epidural ne

Sponsors

Government Medical College and Hospital sector Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

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 >= 36 weeks of gestation 6. In early spontaneous labour (cervical dilation 7. Baseline pain score > 30 (on a 0-100 VAS) 8. Able to use PCEA pump 9. Requesting epidural analgesia for labour

Exclusion criteria

Exclusion criteria: 1. Refusal by parturient. 2. Parturients who had received parenteral opioids in the last 4 hours. 3. Systemic and local sepsis. 4. Deranged coagulation profile. 5. Parturients having multiple pregnancies and premature labour 6. Obstetric complications (e.g., premature rupture of amniotic membranes) 7. Chorioamnionitis 8. Patients with hepatic or renal impairment 9. Unable to swallow oral tablets 10. HELLP syndrome 11. Noncephalic presentations 12. Allergy to study drugs, i.e., levobupivacaine, fentanyl, paracetamol

Design outcomes

Primary

MeasureTime frame
time to achieving adequate analgesia (Numerical Pain Rating Scale score â?¤1)Timepoint: 5min 10 min 15min 20 min 30 min 40 min 50 min 1 hour 2hour 3hour 4 hour 5 hour 6 our 7 hour 8 hour 9 hour 10 hour

Secondary

MeasureTime frame
1.Uterine tachysystole and hypertonus as defined by the National Institute of Child Health and Human Development (NICHD) 2.Maternal satisfaction (VAS) 3.Pain score (NPRS) 4.Sensory and motor block characteristics 5.Haemodynamic parameters of mother 6.Fetal heart rate 7.Duration of second stage of labour 8.Mode of delivery 9.Apgar scores 10.Adverse effects Timepoint: 1.Uterine tachysystole and hypertonus 2.Maternal satisfaction (VAS) 3.Pain score (NPRS) 4.Sensory and motor block characteristics every 5 minfor first 20 min then at 60 min and then 1 hourly till delivary 5.Haemodynamic parameters of mother5,10,15,20,30,40,50,60min and then 1 hourly till delivary 6.Fetal heart rate 5,10,15,20,30,40,50,60min and then 1 hourly till delivary 7.Duration of second stage of labour 8.Mode of delivery 9.Apgar scores 1min and 5 min 10.Adverse effects

Countries

India

Contacts

Public ContactDr Sukanya

GMCH Sector 32 chandigarh

drsmitra12@yahoo.com9646121521

Outcome results

None listed

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