Een gecombineerde spinale epidurale anesthesie bij arbeid : positieve invloed op kwaliteit van analgesie door epiduraal clonidine en neostigmine bij doorbraakpijn?
- Conditions
- Combined spinal-epidural analgesia during labour
- Registration Number
- EUCTR2008-008434-36-BE
- Lead Sponsor
- Marc Van de Velde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 100
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
ASA III and IV
Maternal length < 150 cm and BMI > 40
Suspected congenital disorder
Multiple pregnancy
Cervical dilatation > 7 cm
VAS <50 mm
Allergic to local anesthetics
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>Neonatal outcome based on the APGAR-score and arterial blood test.<br>Duration of labour.<br>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?
- Secondary Outcome Measures
Name Time Method