Etude clinique prospective randomisée en double aveugle de phase 4 comparant la durée d'analgésie postopératoire du fentanyl et du sufentanil administrés comme adjuvant en rachianesthésie dans le cadre de césariennes électives. - SUFRACES
Phase 1
- Conditions
- Pregnant patients with a planned caesarian.MedDRA version: 12.1Level: LLTClassification code 10067385Term: Spinal analgesia
- Registration Number
- EUCTR2010-023528-25-BE
- Lead Sponsor
- CHU Brugmann
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 180
Inclusion Criteria
- 18 years or older
- planned caesarian
- signed informed consent form
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
- loco-regional anesthesia not indicated or refused
- sensitivity to one of the used products
- participation to another clinical trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To delay the first use of morphine after intrathecal anesthesia.;Secondary Objective: - To reduce the quantity of morphine used 24h and 48h after the intrathecal anesthesia.<br><br>- Safety assessment through the frequence of nausea, vomiting and pruritus 24h and 48h after the intrathecal anesthesia;Primary end point(s): Time until the first use of morphine from the intrathecal anesthesia<br>
- Secondary Outcome Measures
Name Time Method