Clinical trial NCT03607916: Estimation of the Effective Dose (ED) 95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery.
Official title: Estimation of the Effective Dose (ED) 95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery : a Dose-finding Study Based on the Continual Reassessment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnant Women
Keywords: Scheduled cesarean delivery,spinal anesthesia,local anesthesia
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Success of anesthesia
timeFrame: during surgery (average 1 hour)
Secondary outcomes:
measure: Level of Sensory block assessed as loss of sensation to pinprick, cold and pressure
timeFrame: Until complete release of sensory block (T12-S1) (average 4 hours)
measure: Side-effects (nausea, vomiting,pruritus)
timeFrame: up to 24 hours after surgery
measure: Transient neurologic symptoms (TNS)
timeFrame: up to 5 Days
measure: Pain as assessed by Visual Analogue Scale (VAS)
timeFrame: during surgery (average 1 hour)
measure: Number of participants with low blood pressure
timeFrame: during surgery (average 1 hour)
measure: Methemoglobinemia
timeFrame: at delivery (average 1 hour)
Other outcomes:
Locations:
city: Brussels Capital Region
country: Belgium
facility: University Hospital Saint-Pierre, Université Libre de Bruxelles
Study officials:
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
name: Panayota KAPESSIDOU, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
name: Philippe Goffard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7.
citation: Gupta PK, Chevret S, Zohar S, Hopkins PM. What is the ED95 of prilocaine for femoral nerve block using ultrasound? Br J Anaesth. 2013 May;110(5):831-6. doi: 10.1093/bja/aes503. Epub 2013 Feb 7.