Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia

Phase 3

Completed

Conditions: Pain
Hypotension
Pregnant Women

Interventions: Drug: Hyperbaric prilocaine
Drug: Hyperbaric bupivacaine

Registration Number: NCT02973048

Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 40

Inclusion Criteria

Not provided

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperbaric prilocaine	Hyperbaric prilocaine	Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine	Hyperbaric bupivacaine	Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.

Primary Outcome Measures

Name	Time	Method
Time to Regression of Motor Block	until complete regression of motor block (up to 4 hours)	Time to regression of motor block is the time between maximal blockade (score 1, as evaluated by the Modified Bromage scale), and no blockade (score 6). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia, then every 15 minutes until the end of surgery, and thereafter, every 30 minutes until complete regression of motor block

Secondary Outcome Measures

Name	Time	Method
Pain as Assessed by Visual Analogue Scale	up to 24 hours after surgery	Pain levels will be determined at incision, baby delivery, peritoneal and skin closure, every 5 minutes during surgery, and thereafter every 4 hours for 24 hours. Visual analog pain score (scale = 0 no pain; 10 = worst pain imaginable). Patient will receive additional analgesic treatment above VAS\>3.
Time to Motor Block Onset	From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour)	Time of installation of the motor block (time between spinal injection and maximum motor block of 1, as evaluated by the Modified Bromage scale). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia
Time to First Walk	up to 24h after surgery	Time for the patients to be able to walk in their room then in the hallway without any assistance for the first time.
Time From Baby Delivery to End of Surgery	average 1 hour	Time between baby delivery, and the end of surgery
Time to Successful Anesthesia (Successful Sensory Block)	From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes)	Time between spinal injection and reached bilateral T4 sensory level.
Time to Resolution of Sensory Block	until complete release of sensory block (T12-S1) (average 4 hours)	Evaluation at every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, and thereafter, every 30 minutes until total regression of sensory block (T12-S1).
Obstetrician Satisfaction	average 1 hour	Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at the end of surgery
Midwife Satisfaction	72 hours after surgery	Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at postoperative Day 3
Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia	until complete release of sensory block (T12-S1) (average 4 hours)	Level of Sensory block is assessed as loss of sensation to cold, and represents the dermatomal level under which anesthesia is effective. It is measured every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once 30 minutes until total regression of sensory block (T12-S1). A dermatome is the area of skin that is supplied by a single spinal nerve - Dermatome levels : C5-C8 for Cervical levels and T1-T4 for Thoracic levels. To perform cesarean section loss of cold sensation at a dermatome of at least T4 has to be obtained. The results are expressed as the number of patients reaching each dermatomal level from T4 and above (see below) as maximal sensory level, this is a usual outcome used to evaluate the quality of anesthesia.
Number of Patients With Hypotension and Use of Vasopressors	up to 2 hours after surgery	Arterial blood pressure will be measured at every 1 minute during the first 15 minutes, then at every 2.5 minutes until the end of surgery, and at every 20 minutes in the Post Anesthesia Care Unit (PACU). A low blood pressure (hypotension) is defined as a systolic blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia)
Number of Participants With Urinary Retention	up to 4 hours after surgery	All parturients will be questioned and examined for urinary retention (yes or no)
Newborn Methemoglobinemia (MetHb)	average 1 hour	Newborn Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control in obstetrics, and expressed as a percentage of total hemoglobinemia. Methemoglobinemia (MetHb) is a blood disorder in which an abnormal amount of methemoglobin (hemoglobin in the form metalloprotein) is produced. This specific type of of Hemoglobin carries oxygen through your blood but doesn't release it to the cells.
Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)	up to 24 hours after surgery	All patients will be asked to rate their satisfaction about anesthetic technique during surgery and in the arrival in the Post Anesthesia Care Unit (PACU). Satisfaction evaluated by Visual analog scale (0 cm= very unsatisfied and 10cm = very satisfied)
Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)	up to 72 hours after surgery	Maternal rehabilitation is evaluated at postoperative Day1, postoperative Day 2 and postoperative Day 3. Evaluation by Visual analog scale (0 cm= very poor and 10cm = excellent)
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)	up to 72 hours after surgery	Evaluation from 15 minutes after spinal injection to the end of surgery, then every 4 hours for 24 hours, then once a day for 3 days (score 0=no symptom; 1=symptom with no necessary treatment; 2=symptom present and treated)
Number of Participants With Transient Neurologic Symptoms (TNS)	up to 15 Days after surgery	Evaluation of apparition of TNS at postoperative Day 1, postoperative Day 2, postoperative Day 3 and postoperative Day 15. TNS are defined as pain and/or dysesthesia occurred after complete release of sensory block at the gluteal level, at the thighs and at the legs.
Time From Spinal Injection to Baby Delivery	average 1 hour	Time between spinal injection and baby delivery
Newborn Apgar Score	up to 10 minutes after baby extraction	Newborn Apgar score assessed at 1, 5, 10 minutes after baby extraction. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from 0 to 2, then summing up the five values thus obtained. The overall resulting score ranges from 0 to 10 ( 0-3 : severely depressed, 4-6 : Moderately depressed and 7-10 : Excellent condition). The five criteria are summarized using words chosen to form an abbreviation (Appearance, Pulse, Grimace, Activity, Respiration).
Newborn Umbilical pH	average 1 hour	Newborn umbilical pH will be assessed at delivery by cordal blood sample, as a routine control, and expressed as standard value
Total Blood Loss	average 1 hour	Total blood loss (milliliters) during surgery
Time of Surgery	average 1 hour	Time between incision and end of surgery

Trial Locations

Locations (2): University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)
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Brussels, Brussels Capital, Belgium
Clinique Ste-Anne/St-Remi
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Anderlecht, Belgium