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

Centre Hospitalier Universitaire Saint Pierre40 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pregnant Women

Interventions

Hyperbaric prilocaine 2%DRUG

Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine

Hyperbaric prilocaine 2%DRUG

The dose of 60 mg of Hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine

MorphineDRUG

100µg morphine

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Saint-Pierre, Université Libre de Bruxelles

Brussels Capital Region, Belgium

Outcomes

Primary Outcomes

Success of anesthesia

The nerve blockade will be considered as success when a bilateral T4 level will reach in 15 minutes after intrathecal injection without additional epidural injection needed within 45 minutes peri-operative ; no pain at the skin incision, no pain during 45 minutes after the skin incision

Time frame: during surgery (average 1 hour)

Secondary Outcomes

Level of Sensory block assessed as loss of sensation to pinprick, cold and pressure

Every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once every hour until total regression of sensory block (T12-S1).

Time frame: Until complete release of sensory block (T12-S1) (average 4 hours)

Side-effects (nausea, vomiting,pruritus)

from 15 minutes after spinal anesthesia and every 4 hours for 24 hours (score 0=no symptoms; 1=symptoms with no treatment necessary; 2=symptoms present and treated)

Time frame: up to 24 hours after surgery

Transient neurologic symptoms (TNS)

TNS are defined as pain and/or dysesthesia occured after complete release of sensory block at the gluteal level, at the tights and at the legs. At Day 0, Day 1, day 3 and Day 5

Time frame: up to 5 Days

Pain as assessed by Visual Analogue Scale (VAS)

Pain levels will be determined every 5 minutes during surgery. The Visual Analogue score (scale : 0 = no pain; 10= worst pain imaginable)

Time frame: during surgery (average 1 hour)

Number of participants with low blood pressure

Arterial blood pressure will be measured at every 2.5 minute during the first 15 minutes, then at every 5 minutes until the end of surgery. A blood pressure lower is define as a blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia)

Data from ClinicalTrials.gov

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