Een gecombineerde spinale epidurale anesthesie bij arbeid : positieve invloed op kwaliteit van analgesie door epiduraal clonidine en neostigmine bij doorbraakpijn?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-008434-36-BE

Enrollment

100

Registered

2009-01-15

Start date

2009-02-12

Completion date

Unknown

Last updated

2024-12-03

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

Conditions

Combined spinal-epidural analgesia during labour

Interventions

Trade Name: Sufenta Pharmaceutical Form: Injection* INN or Proposed INN: SUFENTANIL CAS Number: 56030547 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration numbe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ASA I or II Singleton pregnancy, vertex presented > 37 weeks post-conception Normal pregnancy Informed written consent 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ASA III and IV Maternal length 40 Suspected congenital disorder Multiple pregnancy Cervical dilatation > 7 cm VAS <50 mm Allergic to local anesthetics

Design outcomes

Primary

Measure	Time frame
Main Objective: Is there an analgetic advantage if neostigmine and clonidine is administered epidural together with sufentanyl and ropivacaine.;Secondary Objective: Evaluation of foetal wellbeing based on a cardiotocogram. Neonatal outcome based on the APGAR-score and arterial blood test. Duration of labour. Side effects ie. nausea, pruritus, sedation, motoric block, maternal hypotension and bradycardy ;Primary end point(s): Is there a increased analgetic effect if clonidine and neostigmine is administred epidurally together with sufentanil and ropivacaine?	—

Measure

Time frame

Main Objective: Is there an analgetic advantage if neostigmine and clonidine is administered epidural together with sufentanyl and ropivacaine.;Secondary Objective: Evaluation of foetal wellbeing based on a cardiotocogram. Neonatal outcome based on the APGAR-score and arterial blood test. Duration of labour. Side effects ie. nausea, pruritus, sedation, motoric block, maternal hypotension and bradycardy ;Primary end point(s): Is there a increased analgetic effect if clonidine and neostigmine is administred epidurally together with sufentanil and ropivacaine?

—

Countries

Belgium

Outcome results

None listed

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