EUCTR2017-002921-39-FRActive, not recruitingPhase 1
Comparison of motor blockade duration in the context of scheduled caesarean section with spinal anaesthesia : hyperbaric Prilocaïne versus hyperbaric Bupivacaïne. - Césarcaïne
niversity hospital of Montpellier0 sites50 target enrollmentStarted: January 12, 2018Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •- Scheduled C-section
- •- Eutocic pregnancy
- •- Non-multiple pregnancy
- •- Age : over 18-years-old
- •- Height : between 155cm and 175cm
- •- Patient affiliated or beneficiary of healthcare protection
- •- Signature of 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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •- Underage patient
- •- Pathological pregnancy
- •- Multiple pregnancy
- •- Emergency C-section
- •- Patient not speaking french
- •- Patient refusal
- •- spinal anaesthesia contraindication :
- •.Cutaneous infection at the injection point
- •.Coagulation disorder
- •.Lumbar equipment at needle-puncture site
- •- Prilocaïne contraindication :
- •.Allergy to Prilocaine or other amide local anaesthetic, or allergy to any excipient of BARITEKAL®
- •.Severe cardiac conduction abnormality
- •.Severe anaemia
- •.Decompensated heart failure
- •.Cardiogenic and hypovolemic shock
- •.Congenital or acquired methemoglobinemia
- •.Concomitant treatment by blood thinner
- •.Methemoglobinemia contributing factors (Dapsone, Cotrimoxazole, antimalarial treatments, nitroprusside, nitrates, nitrofurane, oxyde nitrique, 8-hydrosiquinoleine, phenacetin, phenazorydine, resercine)
- •- Bupivacaïne contraindication :
- •.Allergy to local amide anesthetic
- •.IV local anaesthesia
Investigators
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