Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia
Condition: Pregnant Women; Pain; Hypotension
MeSH terms: Hypotension
Intervention: Hyperbaric bupivacaine; Hyperbaric prilocaine
Intervention description: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.; The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
Intervention MeSH terms: Bupivacaine; Prilocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Cesarean delivery; Spinal anesthesia; Local anesthetics

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.
    

Eligibility 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