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NCT Number: NCT03036384

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

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)

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Key information

Conditions

Pregnant Women

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)

Brussels Capital Region, 1000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HB Prilocaine 2% (varying dose)

Drug

Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl

Other names: Tachipri

HB Prilocaine 2%

Drug

The dose of 45mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl

Other names: Tachipri

Sufentanil

Drug

2.5µg sufentanyl

Morphine

Drug

100 µg Morphine

Primary outcomes

  1. Success of Anesthesia

    Time frame: during surgery (average 1 hour)

    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

Secondary outcomes

  1. Sensitive Block Duration

    Time frame: Until complete release of sensory block (T12-S1) (average 4 hours)

    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).

  2. Sensitive Block at End of Surgery

    Time frame: Until complete release of sensory block (T12-S1) (average 4 hours)

    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)

  3. Motor Block Duration

    Time frame: Until complete release of motor block (Bromage scale = 1; average 4 hours)

    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.

  4. Bromage Motor Block Level at End of Surgery

    Time frame: Until complete release of motor block (average 4 hours)

    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.

  5. Newborn Apgar Score

    Time frame: 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).

  6. Newborn Methemoglobinemia (MetHb)

    Time frame: average 1 hour

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

  7. Number of Participants Needing Vasopressors

    Time frame: during surgery (average 1 hour)

    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).

  8. Number of Participants With Transient Neurologic Symptoms (TNS)

    Time frame: up to 5 Days

    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

  9. Number of Participants With Nausea or Vomiting

    Time frame: up to 24 hours after surgery

    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)

  10. Number of Participants With Pruritus

    Time frame: Up to 24 hours after surgery

    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)

  11. Number of Participants With Urinary Retention

    Time frame: Up to 24 hours after surgery

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

  12. Number of Participants With Dizziness

    Time frame: Up to 24 hours after surgery

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

  13. Number of Satisfied Participants

    Time frame: up to 1 hour after surgery

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 30, 2017
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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