Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia

• Status: Completed
• Trial end date: 2018-11-08
• Target enrollment: 0
• Participant gender: Female

Summary

Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite effective surgical anesthesia, bupivacaine is associated with long duration motor block and dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and faster regression of motor block compared to other local anesthetics without noteworthy side-effects when used intrathecally. The aim of this randomized, multicenter, powered clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers shorter motor block and more rapid rehabilitation than bupivacaine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria :

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

• Age 18-40 year

• Body Weight <110 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

• Intrauterine growth retardation

• Patient in labour

• Membrane rupture

• Known allergy to local anaesthetics

• Standard contraindications to neuraxial block.

• Disagreement of the patient

• Neurological impairment

• Gestational low blood pressure

• Pre eclampsia and eclampsia