Combined spinal -epidural analgesia during labour.
Conditions
Interventions
Trade Name: Sufenta
Pharmaceutical Form: Injection*
INN or Proposed INN: SUFENTANIL
CAS Number: 5600547
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number
Sponsors
Marc Van de Velde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ASA I or II Singleton pregnancy, vertex presented > 37 weeks post-conception Nomal 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 VAS < 50 mm Allergic to local anesthetics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is there an analgetic advantage if nestigmine and clonidine is administered by PCEA (patient controlled epidural analgesia) 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. pruritis, sedation, motoric block, need for tocolytica, maternal hypotension and bradycardy.;Primary end point(s): Is there an increased analgetic effect if clonidine is administred epidurally (by patient controlled epidural analgesia) together with sufentanyl and ropivacaine? | — |
Countries
Belgium
Outcome results
None listed