Clinical trial NCT02973048: Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia
Official title: Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnant Women
Pain
Hypotension
Keywords: Cesarean delivery
Spinal anesthesia
Local anesthetics
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite effective surgical anesthesia, bupivacaine is associated with long duration motor block and dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and faster regression of motor block compared to other local anesthetics without noteworthy side-effects when used intrathecally. The aim of this randomized, multicenter, powered clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers shorter motor block and more rapid rehabilitation than bupivacaine.


Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Time to Regression of Motor Block
timeFrame: until complete regression of motor block (up to 4 hours)
Secondary outcomes:
measure: Time to Successful Anesthesia (Successful Sensory Block)
timeFrame: From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes)
measure: Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
timeFrame: until complete release of sensory block (T12-S1) (average 4 hours)
measure: Time to Resolution of Sensory Block
timeFrame: until complete release of sensory block (T12-S1) (average 4 hours)
measure: Time to Motor Block Onset
timeFrame: From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour)
measure: Number of Patients With Hypotension and Use of Vasopressors
timeFrame: up to 2 hours after surgery
measure: Number of Participants With Urinary Retention
timeFrame: up to 4 hours after surgery
measure: Time to First Walk
timeFrame: up to 24h after surgery
measure: Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)
timeFrame: up to 24 hours after surgery
measure: Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)
timeFrame: up to 72 hours after surgery
measure: Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
timeFrame: up to 72 hours after surgery
measure: Number of Participants With Transient Neurologic Symptoms (TNS)
timeFrame: up to 15 Days after surgery
measure: Pain as Assessed by Visual Analogue Scale
timeFrame: up to 24 hours after surgery
measure: Newborn Apgar Score
timeFrame: up to 10 minutes after baby extraction
measure: Newborn Methemoglobinemia (MetHb)
timeFrame: average 1 hour
measure: Newborn Umbilical pH
timeFrame: average 1 hour
measure: Time of Surgery
timeFrame: average 1 hour
measure: Time From Spinal Injection to Baby Delivery
timeFrame: average 1 hour
measure: Time From Baby Delivery to End of Surgery
timeFrame: average 1 hour
measure: Total Blood Loss
timeFrame: average 1 hour
measure: Obstetrician Satisfaction
timeFrame: average 1 hour
measure: Midwife Satisfaction
timeFrame: 72 hours after surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)
state: Brussels Capital
city: Anderlecht
country: Belgium
facility: Clinique Ste-Anne/St-Remi
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: Gautier P, De Kock M, Huberty L, Demir T, Izydorczic M, Vanderick B. Comparison of the effects of intrathecal ropivacaine, levobupivacaine, and bupivacaine for Caesarean section. Br J Anaesth. 2003 Nov;91(5):684-9. doi: 10.1093/bja/aeg251.
citation: Guntz E, Latrech B, Tsiberidis C, Gouwy J, Kapessidou Y. ED50 and ED90 of intrathecal hyperbaric 2% prilocaine in ambulatory knee arthroscopy. Can J Anaesth. 2014 Sep;61(9):801-7. doi: 10.1007/s12630-014-0189-7. Epub 2014 Jun 7.
citation: Guntz E, Kapessidou Y. Spinal prilocaine for same-day surgery: the importance of equipotent doses. Can J Anaesth. 2016 Aug;63(8):985-6. doi: 10.1007/s12630-016-0645-7. Epub 2016 Apr 4. No abstract available.
citation: Goffard P, Leloup R, Vercruysse Y, Fils JF, Gautier PE, Kapessidou Y. Comparison of equipotent doses of intrathecal hyperbaric prilocaine 2% and hyperbaric bupivacaine 0.5% for elective caesarean section: A prospective, randomised, controlled, two-centre clinical trial. Eur J Anaesthesiol. 2022 Mar 1;39(3):227-235. doi: 10.1097/EJA.0000000000001548.