Pregnant Women
Conditions
Keywords
Scheduled cesarean delivery,spinal anesthesia,local anesthesia
Brief summary
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)
Interventions
DRUGHyperbaric prilocaine 2%
Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
DRUGMorphine
100µg morphine
Sponsors
Centre Hospitalier Universitaire Saint Pierre
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of anesthesia | during surgery (average 1 hour) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side-effects (nausea, vomiting,pruritus) | up to 24 hours after surgery | 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) |
| Transient neurologic symptoms (TNS) | up to 5 Days | 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 |
| Level of Sensory block assessed as loss of sensation to pinprick, cold and pressure | Until complete release of sensory block (T12-S1) (average 4 hours) | 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). |
| Number of participants with low blood pressure | during surgery (average 1 hour) | 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) |
| Methemoglobinemia | at delivery (average 1 hour) | Methemoglobin level measured in umbilical cord blood of new born at the delivery |
| Pain as assessed by Visual Analogue Scale (VAS) | during surgery (average 1 hour) | Pain levels will be determined every 5 minutes during surgery. The Visual Analogue score (scale : 0 = no pain; 10= worst pain imaginable) |
Countries
Belgium
Outcome results
None listed