Comparison of two anaesthetics used in scheduled caesarean section in terms of post anaesthesia immobilisation duration : hyperbaric Prilocaïne versus hyperbaric Bupivacaïne.

Phase 1

• Conditions: Caesarean section anaesthesia; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-002921-39-FR
• Lead Sponsor: niversity hospital of Montpellier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-12
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 50

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
.Sepsis
.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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified