- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03036384
Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery
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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Brussels Capital Region, Belgium, 1000
- University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
The dose of 45mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl
Other Names:
2.5µg sufentanyl
100 µg 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.
|
2.5µg sufentanyl
100 µg Morphine
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:
|
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.
|
2.5µg sufentanyl
100 µg Morphine
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:
|
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.
|
2.5µg sufentanyl
100 µg Morphine
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:
|
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.
|
2.5µg sufentanyl
100 µg Morphine
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:
|
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.
|
2.5µg sufentanyl
100 µg Morphine
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:
|
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.
|
2.5µg sufentanyl
100 µg Morphine
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:
|
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.
|
2.5µg sufentanyl
100 µg Morphine
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:
|
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.
|
2.5µg sufentanyl
100 µg Morphine
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:
|
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.
|
2.5µg sufentanyl
100 µg Morphine
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
during surgery (average 1 hour)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
up to 10 minutes after baby extraction
|
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).
|
Until complete release of sensory block (T12-S1) (average 4 hours)
|
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)
|
Until complete release of sensory block (T12-S1) (average 4 hours)
|
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.
|
Until complete release of motor block (Bromage scale = 1; average 4 hours)
|
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.
|
Until complete release of motor block (average 4 hours)
|
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.
|
average 1 hour
|
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). |
during surgery (average 1 hour)
|
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
|
up to 5 Days
|
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)
|
up to 24 hours after surgery
|
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)
|
Up to 24 hours after surgery
|
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)
|
Up to 24 hours after surgery
|
Number of Participants With Dizziness
Time Frame: Up to 24 hours after surgery
|
All parturients will be questioned for dizziness (yes or no)
|
Up to 24 hours after surgery
|
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)
|
up to 1 hour after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Philippe Goffard, MD, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Publications and helpful links
General Publications
- Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7.
- Gupta PK, Chevret S, Zohar S, Hopkins PM. What is the ED95 of prilocaine for femoral nerve block using ultrasound? Br J Anaesth. 2013 May;110(5):831-6. doi: 10.1093/bja/aes503. Epub 2013 Feb 7.
- Goffard P, Vercruysse Y, Leloup R, Fils JF, Chevret S, Kapessidou Y. Determination of the ED95 of intrathecal hyperbaric prilocaine with sufentanil for scheduled cesarean delivery: a dose-finding study based on the continual reassessment method. BMC Anesthesiol. 2020 Nov 26;20(1):293. doi: 10.1186/s12871-020-01199-0.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NB076201627436
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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