Alleviation of labour pain by epidural or spinal analgetic

Spinal or epidural fentanyl or sufentanil for labour pain in early phase of the labour

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000486-23-FI

Enrollment

Registered

2016-04-14

Start date

2016-08-10

Completion date

Unknown

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labour pain MedDRA version: 18.1 Level: LLT Classification code 10023554 Term: Labour pains stopped System Organ Class: 100000004868

Interventions

Trade Name: SUFENTA injektioneste, liuos 5 mikrog/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: SUFENTANIL CITRATE CAS Number: 60561-17-3 Concentration unit: µg/ml microgram(s)/m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Primiparous parturients In early phase of labour (cervical dilatation at or under 5 cm) No prior opioids by any route of administration within past 120 min Pain at or over 80 mm on 0-100 mm visual analog scale during contraction Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Allergy for any of the medications used Contraindications for epidural/spinal analgesia BMI at the time of delivery under 20 or over 35 kg/m2

Design outcomes

Primary

Measure	Time frame
Main Objective: Alleviation of labour pain at 20 minutes after intervention;Secondary Objective: Duration of the achieved labour pain relief;Primary end point(s): Achieved level of analgesia at 20 minutes after the administration of spinal or epidural analgesia;Timepoint(s) of evaluation of this end point: 20 minutes after administration of analgesia	—

Secondary

Measure	Time frame
Secondary end point(s): The duration of achieved analgesia in minutes Time from spinal/epidural analgesia to delivery;Timepoint(s) of evaluation of this end point: Estimated to be within 5-8 hours after administration of the study drug spinally or epidurally	—

Countries

Finland

Contacts

Public ContactKatilo-opiston sairaala/dept of ane

Helsinki University Central Hospital

antti.vaananen@hus.fi358504271850

Outcome results

None listed

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