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

Centre Hospitalier Universitaire Saint Pierre

Status and phase: Completed; Phase 3

Conditions: Hypotension; Pregnant Women; Pain

Treatments: Drug: Hyperbaric prilocaine; Drug: Hyperbaric bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02973048

B076201627677

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Hyperbaric bupivacaine

Placebo Comparator group

Description:

Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.

Treatment:

Drug: Hyperbaric bupivacaine

Hyperbaric prilocaine

Active Comparator group

Description:

Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.

Treatment:

Drug: Hyperbaric prilocaine