Comparative double blind study with Hyperbaric Bupivacaine 0.5% and Hyperbaric Prilocaine 2% for scheduled cesarean section Under Spinal Anesthesia

Phase 1

Conditions: Parturients undergoing an elective caesarean section performed under spinal anaesthesia
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2016-003010-26-BE

Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre , ULB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 100

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

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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Twin pregnancy
•History of 2 cesarean section or more
•Diabetes and gestational diabetes
•Placenta praevia
•Congenital foetale 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Not applicable;Primary end point(s): The primary outcome that will be analysed in this study is the time to motor block resolution after intrathecal injection of the two local anaesthetics (Motor block regression time);Timepoint(s) of evaluation of this end point: Perioperative;Main Objective: The goal of this trial is to investigate whether Hyperbaric Prilocaine may be an efficient alternative to Hyperbaric Bupivacaine for scheduled cesarean delivery under spinal anesthesia, with more rapid rehabilitation and less secondary effects.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Time to successful anaesthesia<br>- Level of sensory block<br>- Sensory block resolution<br>- Time to motor block onset <br>- Side effects (nausea and vomiting)<br>- Pain (VAS score)<br>- Time to void<br>- Percentage of patients with hypotension<br>- Maternal satisfaction (VASS)<br>- Maternal rehabilitation (VASR and QoR score)<br><br>;Timepoint(s) of evaluation of this end point: Perioperative and post operative up to Day 3