Trial Outcomes & Findings for Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery (NCT NCT03036384)

All participants were recruited at CHU Saint-Pierre.

Possible doses of HB prilocaine range from 30 to 55mg, but actual administrated doses will be defined by CRM

Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery

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

Level of Sensory block assessed as loss of sensation to cold, 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).

Level of Sensory block assessed as loss of sensation to cold, 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). For this study, dermatome levels are depicted on a scale ranging from 1 to 18. (1 to 12 = T1-T12 thoracic levels; 13 to 17 = L1-L5 lumbar levels; 18 = S1 sacral level)

Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 minutes after spinal anaesthesia (T0) and until the end of surgery. Duration was defined from the time of the spinal injection until Bromage scale = 1.

Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 min after spinal anaesthesia (T0) and until the end of surgery.

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 Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control, and expressed as a percentage of total hemoglobinemia.

Arterial blood pressure will be measured at every 2.5 minute during surgery, then at every 20 minutes in the PACU (Post Anesthesia Care Unit). Vasopressors were given for patients with low blood pressure. A low blood pressure is defined as a blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia).

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. At Day 0, Day 1, Day 3 and Day 5

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)

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)

All parturients will be questioned for urinary retention (yes or no)

All parturients will be questioned for dizziness (yes or no)

Maternal satisfaction (yes or no) will be assessed 1 hour after surgery in the PACU (Post Anesthesia Care Unit)