Intravensko lajšanje porodnih bolecin z remifentanilom, ki si ga uravnava porodnica sama – primerjava protokola brez uporabe bazalne infuzije in protokola z uporabo bazalne infuzije glede kvalitete lajšanja porodnih bolecin in varnosti uporabe Intravenous patient controlled pain relief during labour with remifentanil - a comparison of the protocol without the use of basal infusion and the protocol using a basal infusion on the quality of pain relief and the safety of its use - Remi - PCA - koncentracije

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016752-52-SI

Enrollment

Registered

2009-12-14

Start date

2010-03-24

Completion date

Unknown

Last updated

2024-09-23

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

Conditions

labour pain MedDRA version: 12.0 Level: LLT Classification code 10059204 Term: Labour pain

Interventions

Trade Name: Ultiva Product Name: Ultiva Pharmaceutical Form: Powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age over 18 years - Body weight between 50 and 100 kg - Spontaneous or induced labour - Request for the relief of pain birth - Gestational age of fetus at least 35 weeks - Cephalic presentation - CTG normal before the start of pain relief Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Allergy to opioids - History of illegal drugs use or alcohol dependency - Age under 18 years - Diabetes, pregnancy induced arterial hypertension - Contraindication for use of labour epidural analgesia (bleeding disorders, infection at the injection site, fear of epidural puncture and its consequences, ...) - Pathological CTG before the start of pain relief / fetal distress from any cause - Twins, breech presentation - IUGR with an estimated fetal weight <2500 g - Congenital / chronic disease in a child found after birth (hereditary diseases, malformations, inherent metabolic disorders , ...)

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective of the trial is to show that relief of labour pain with remifentanil that mother adjusts itself in patient controlled infusion mode using also a basal infusion is more effective in terms of pain reduction, greater satisfaction with the method and frequency of side effects compared to the protocol without basal infusion and comparable regarding safety for the newborn and mother.;Secondary Objective: Secondary endpoints are to describe the frequency of accompanying phenomena, remifentanil impact on the duration of the first birth period, impact on the way of delivery and the need for more intensive measures with the newborn immediately at birth and in the immediate postpartum period;Primary end point(s): -Is there a difference in the quality of pain relief during labor between the two groups? (N-VAS-pain, VAS-satisfaction) - What is the probability of neonatal respiratory depresion? - Is there a difference in remifentanil blood concentration between newborns in the two groups at delivery? (remifentanil blood concentration) - Is the use of remifentanil during labour safe? (maternal sedation, saturation, respiratory rate, heart rate, blood pressure, arterial blood gas analysis, nenatal CTG, Apgar 1st and 5 and 10 minutes)	—

Measure

Time frame

Main Objective: Main objective of the trial is to show that relief of labour pain with remifentanil that mother adjusts itself in patient controlled infusion mode using also a basal infusion is more effective in terms of pain reduction, greater satisfaction with the method and frequency of side effects compared to the protocol without basal infusion and comparable regarding safety for the newborn and mother.;Secondary Objective: Secondary endpoints are to describe the frequency of accompanying phenomena, remifentanil impact on the duration of the first birth period, impact on the way of delivery and the need for more intensive measures with the newborn immediately at birth and in the immediate postpartum period;Primary end point(s): -Is there a difference in the quality of pain relief during labor between the two groups? (N-VAS-pain, VAS-satisfaction) - What is the probability of neonatal respiratory depresion? - Is there a difference in remifentanil blood concentration between newborns in the two groups at delivery? (remifentanil blood concentration) - Is the use of remifentanil during labour safe? (maternal sedation, saturation, respiratory rate, heart rate, blood pressure, arterial blood gas analysis, nenatal CTG, Apgar 1st and 5 and 10 minutes)

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Countries

Slovenia

Outcome results

None listed

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