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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03036384
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : April 20, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre

Tracking Information
First Submitted Date  ICMJE January 12, 2017
First Posted Date  ICMJE January 30, 2017
Results First Submitted Date  ICMJE March 20, 2020
Results First Posted Date  ICMJE April 20, 2020
Last Update Posted Date May 6, 2020
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
  • 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).
  • 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)
  • 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.
  • 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.
  • 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).
  • 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.
  • 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).
  • 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
  • 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)
  • 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)
  • 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)
  • Number of Participants With Dizziness [ Time Frame: Up to 24 hours after surgery ]
    All parturients will be questioned for dizziness (yes or no)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • 2. Level of Sensory block assessed as loss of sensation to pinprick, cold and pressure [ Time Frame: Until complete release of sensory block (T12-S1) (average 4 hours) ]
    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).
  • Side-effects (nausea, vomiting,prurit) [ 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)
  • 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 tighs and at the legs. At Day 0, Day 1, Day 3 and Day 5
  • Pain as assessed by Visual Analog Scale [ Time Frame: 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)
  • Number of participants with low blood pressure [ 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). A blood pressure lower is define as a blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery
Official Title  ICMJE 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)
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pregnant Women
Intervention  ICMJE
  • Drug: HB Prilocaine 2% (varying dose)
    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 Name: Tachipri
  • Drug: HB Prilocaine 2%
    The dose of 45mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl
    Other Name: Tachipri
  • Drug: Sufentanil
    2.5µg sufentanyl
  • Drug: Morphine
    100 µg Morphine
Study Arms  ICMJE
  • Experimental: Cohort 1 : HB prilocaine 2%, 45mg
    Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.
    Interventions:
    • Drug: HB Prilocaine 2%
    • Drug: Sufentanil
    • Drug: Morphine
  • Experimental: Cohort 2 : HB prilocaine 2%, (30-55mg)
    Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.
    Interventions:
    • Drug: HB Prilocaine 2% (varying dose)
    • Drug: Sufentanil
    • Drug: Morphine
  • Experimental: Cohort 3 : HB prilocaine 2%, (30-55mg)
    Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.
    Interventions:
    • Drug: HB Prilocaine 2% (varying dose)
    • Drug: Sufentanil
    • Drug: Morphine
  • Experimental: Cohort 4 : HB prilocaine 2%, (30-55mg)
    Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.
    Interventions:
    • Drug: HB Prilocaine 2% (varying dose)
    • Drug: Sufentanil
    • Drug: Morphine
  • Experimental: Cohort 5 : HB prilocaine 2%, (30-55mg)
    Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.
    Interventions:
    • Drug: HB Prilocaine 2% (varying dose)
    • Drug: Sufentanil
    • Drug: Morphine
  • Experimental: Cohort 6 : HB prilocaine 2%, (30-55mg)
    Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.
    Interventions:
    • Drug: HB Prilocaine 2% (varying dose)
    • Drug: Sufentanil
    • Drug: Morphine
  • Experimental: Cohort 7 : HB prilocaine 2%, (30-55mg)
    Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.
    Interventions:
    • Drug: HB Prilocaine 2% (varying dose)
    • Drug: Sufentanil
    • Drug: Morphine
  • Experimental: Cohort 8 : HB prilocaine 2%, (30-55mg)
    Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.
    Interventions:
    • Drug: HB Prilocaine 2% (varying dose)
    • Drug: Sufentanil
    • Drug: Morphine
  • Experimental: Cohort 9 : HB prilocaine 2%, (30-55mg)
    Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.
    Interventions:
    • Drug: HB Prilocaine 2% (varying dose)
    • Drug: Sufentanil
    • Drug: Morphine
  • Experimental: Cohort 10 : HB prilocaine 2%, (30-55mg)
    Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg.
    Interventions:
    • Drug: HB Prilocaine 2% (varying dose)
    • Drug: Sufentanil
    • Drug: Morphine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2017)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03036384
Other Study ID Numbers  ICMJE NB076201627436
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire Saint Pierre
Study Sponsor  ICMJE Centre Hospitalier Universitaire Saint Pierre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Panayota Kapessidou, MD,PhD University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Principal Investigator: Philippe Goffard, MD University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
PRS Account Centre Hospitalier Universitaire Saint Pierre
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP