Clinical trial NCT03036384: Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery
Official title: Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery : a Dose-finding Study Bases on the Continual Reassessment Method (CRM)
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: 2017-01-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly used for spinal injection in cesarean section. Nevertheless, its use often results in a long duration of motor nerve block and a haemodynamical instability. Recently developped, the Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the effect of the local anesthetics while decreasing their dose-related side effects, the aim of this study is to determine the ED95 of hyperbaric prilocaine 2% with sufentanyl for scheduled cesarean delivery under spinal anesthesia,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 155 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: Sensitive Block Duration
timeFrame: Until complete release of sensory block (T12-S1) (average 4 hours)
measure: Sensitive Block at End of Surgery
timeFrame: Until complete release of sensory block (T12-S1) (average 4 hours)
measure: Motor Block Duration
timeFrame: Until complete release of motor block (Bromage scale = 1; average 4 hours)
measure: Bromage Motor Block Level at End of Surgery
timeFrame: Until complete release of motor block (average 4 hours)
measure: Newborn Apgar Score
timeFrame: up to 10 minutes after baby extraction
measure: Newborn Methemoglobinemia (MetHb)
timeFrame: average 1 hour
measure: Number of Participants Needing Vasopressors
timeFrame: during surgery (average 1 hour)
measure: Number of Participants With Transient Neurologic Symptoms (TNS)
timeFrame: up to 5 Days
measure: Number of Participants With Nausea or Vomiting
timeFrame: up to 24 hours after surgery
measure: Number of Participants With Pruritus
timeFrame: Up to 24 hours after surgery
measure: Number of Participants With Urinary Retention
timeFrame: Up to 24 hours after surgery
measure: Number of Participants With Dizziness
timeFrame: Up to 24 hours after surgery
measure: Number of Satisfied Participants
timeFrame: up to 1 hour after surgery
Other outcomes:
Locations:
city: Brussels Capital Region
country: Belgium
facility: University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)
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.
citation: Goffard P, Vercruysse Y, Leloup R, Fils JF, Chevret S, Kapessidou Y. Determination of the ED95 of intrathecal hyperbaric prilocaine with sufentanil for scheduled cesarean delivery: a dose-finding study based on the continual reassessment method. BMC Anesthesiol. 2020 Nov 26;20(1):293. doi: 10.1186/s12871-020-01199-0.