Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery
1 other identifier
interventional
40
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2016
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 12, 2017
CompletedFirst Posted
Study publicly available on registry
January 30, 2017
CompletedResults Posted
Study results publicly available
April 20, 2020
CompletedMay 6, 2020
April 1, 2020
8 months
January 12, 2017
March 20, 2020
April 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Success of Anesthesia
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 Outcomes (13)
Sensitive Block Duration
Until complete release of sensory block (T12-S1) (average 4 hours)
Sensitive Block at End of Surgery
Until complete release of sensory block (T12-S1) (average 4 hours)
Motor Block Duration
Until complete release of motor block (Bromage scale = 1; average 4 hours)
Bromage Motor Block Level at End of Surgery
Until complete release of motor block (average 4 hours)
Newborn Apgar Score
up to 10 minutes after baby extraction
- +8 more secondary outcomes
Study Arms (10)
Cohort 1 : HB prilocaine 2%, 45mg
EXPERIMENTALDose-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.
Cohort 2 : HB prilocaine 2%, (30-55mg)
EXPERIMENTALDose-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.
Cohort 3 : HB prilocaine 2%, (30-55mg)
EXPERIMENTALDose-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.
Cohort 4 : HB prilocaine 2%, (30-55mg)
EXPERIMENTALDose-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.
Cohort 5 : HB prilocaine 2%, (30-55mg)
EXPERIMENTALDose-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.
Cohort 6 : HB prilocaine 2%, (30-55mg)
EXPERIMENTALDose-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.
Cohort 7 : HB prilocaine 2%, (30-55mg)
EXPERIMENTALDose-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.
Cohort 8 : HB prilocaine 2%, (30-55mg)
EXPERIMENTALDose-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.
Cohort 9 : HB prilocaine 2%, (30-55mg)
EXPERIMENTALDose-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.
Cohort 10 : HB prilocaine 2%, (30-55mg)
EXPERIMENTALDose-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
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
The dose of 45mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl
2.5µg sufentanyl
100 µg Morphine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)
Brussels Capital Region, 1000, Belgium
Related Publications (3)
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.
PMID: 20529983BACKGROUNDGupta 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.
PMID: 23393153BACKGROUNDGoffard 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.
PMID: 33243149DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Panayota Kapessidou
- Organization
- Centre Hospitalier Universitaire Saint Pierre
Study Officials
- 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)
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2017
First Posted
January 30, 2017
Study Start
March 1, 2016
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
May 6, 2020
Results First Posted
April 20, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share