Estimation of the Effective Dose (ED) 95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery.

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Prilocaine is a local anesthetic drug which as an intermediate duration of action shorter than bupivacaine 0,5% that is usually used for spinal anesthesia in scheduled cesarean section. No study has yet investigated the use of hyperbaric (HB) prilocaine 2% for intrathecal anesthesia in cesarean section. The aim of this study is to determine the Effective Dose (ED) 95 of hyperbaric (HB) prilocaine 2% by using the Continual Reassessment Method (CRM)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre
• Treatments: Morphine; Prilocaine

Criteria

Inclusion Criteria:

• American Society of Anesthesiologists physical status (ASA) < III

• Age 18-40 year

• Body Weight <100 kg

• Height between 160 and 175 cm

• Gestational age>37 SA

• Elective cesarean delivery

• Singleton pregnancy

• Non complicated pregnancy

• Signed informed consent obtained prior to any study specific assessments and procedures

Exclusion Criteria:

• Twin pregnancy

• History of 2 cesarean section or more

• Diabetes and gestational diabetes

• Placenta praevia

• Congenital foetal abnormality

• Patient in labour

• Membrane rupture

• Known allergy to local anaesthetics

• Disagreement of the patient

• Pregnancy-induced hypertension

• Pre eclampsia and eclampsia