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Pregnant WomenPhase 2NCT03607916

Estimation of the Effective Dose (ED) 95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery.

A Phase 2 study testing Hyperbaric prilocaine 2% and Morphine in people with Pregnant Women, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prilocaine is a local anesthetic drug which as an intermediate duration of action shorter than bupivacaine 0,5% that is usually used for spinal anesthesia in scheduled cesarean section. No study has yet investigated the use of hyperbaric (HB) prilocaine 2% for intrathecal anesthesia in cesarean section. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Pregnant Women
What is being tested?
Hyperbaric prilocaine 2% and Morphine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBelgium
Study dates
Feb 2014to Aug 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • American Society of Anesthesiologists physical status (ASA) < III
  • Age 18-40 year
  • Body Weight <100 kg
  • Height between 160 and 175 cm
  • Gestational age>37 SA
  • Elective cesarean delivery
Show all 9Show fewer
  • Singleton pregnancy
  • Non complicated pregnancy
  • Signed informed consent obtained prior to any study specific assessments and procedures

Who cannot join

  • Twin pregnancy
  • History of 2 cesarean section or more
  • Diabetes and gestational diabetes
  • Placenta praevia
  • Congenital foetal abnormality
  • Patient in labour
Show all 11Show fewer
  • Membrane rupture
  • Known allergy to local anaesthetics
  • Disagreement of the patient
  • Pregnancy-induced hypertension
  • Pre eclampsia and eclampsia

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • University Hospital Saint-Pierre, Université Libre de Bruxelles

    Brussels Capital Region, 1000

Other trials in Belgium

About this study

Official title: Estimation of the Effective Dose (ED) 95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery : a Dose-finding Study Based on the Continual Reassessment.

Prilocaine is a local anesthetic drug which as an intermediate duration of action shorter than bupivacaine 0,5% that is usually used for spinal anesthesia in scheduled cesarean section. No study has yet investigated the use of hyperbaric (HB) prilocaine 2% for intrathecal anesthesia in cesarean section. The aim of this study is to determine the Effective Dose (ED) 95 of hyperbaric (HB) prilocaine 2% by using the Continual Reassessment Method (CRM)

Conditions
Pregnant Women
Being tested
Hyperbaric prilocaine 2%, Morphine
Keywords
Scheduled cesarean delivery,spinal anesthesia,local anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperbaric prilocaine 2%Drug

    Also called Tachipri

    Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine

  • Hyperbaric prilocaine 2%Drug

    Also called Tachipri

    The dose of 60 mg of Hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine

  • MorphineDrug

    100µg morphine

Study groups in NCT03607916
Study groupRoleWhat they receive
Cohort 1 : HB Prilocaine 2%,(60mg)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% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.
Receives: Drug: Hyperbaric prilocaine 2%; Drug: Morphine
Cohort 2 : HB Prilocaine 2%,(45-70mg)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% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.
Receives: Drug: Hyperbaric prilocaine 2%; Drug: Morphine
Cohort 3 : HB Prilocaine 2%,(45-70mg)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% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.
Receives: Drug: Hyperbaric prilocaine 2%; Drug: Morphine
Cohort 4 : HB Prilocaine 2%,(45-70mg)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% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.
Receives: Drug: Hyperbaric prilocaine 2%; Drug: Morphine
Cohort 5 : HB Prilocaine 2%,(45-70mg)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% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.
Receives: Drug: Hyperbaric prilocaine 2%; Drug: Morphine
Cohort 6 : HB Prilocaine 2%,(45-70mg)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% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.
Receives: Drug: Hyperbaric prilocaine 2%; Drug: Morphine
Cohort 7 : HB Prilocaine 2%,(45-70mg)ExperimentalDose-finding study with 4 subjects per dose and a maximum of 40 paturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2% will be adminitrated at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.
Receives: Drug: Hyperbaric prilocaine 2%; Drug: Morphine
Cohort 8 : HB Prilocaïne 2%,(45-70mg)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% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.
Receives: Drug: Hyperbaric prilocaine 2%; Drug: Morphine
Cohort 9 : HB Prilocaine 2%,(45-70mg)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% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.
Receives: Drug: Hyperbaric prilocaine 2%; Drug: Morphine
Cohort 10 : HB Prilocaine 2%,(45-70mg)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% will be administered at the dose initial of 60 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). The dose range will be from 45 to 70mg.
Receives: Drug: Hyperbaric prilocaine 2%; Drug: Morphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: during surgery (average 1 hour)

Secondary outcomes (6)

  1. Level of Sensory block assessed as loss of sensation to pinprick, cold and pressure

    Every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once every hour until total regression of sensory block (T12-S1).

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

  2. Side-effects (nausea, vomiting,pruritus)

    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)

    Measured: up to 24 hours after surgery

  3. Transient neurologic symptoms (TNS)

    TNS are defined as pain and/or dysesthesia occured after complete release of sensory block at the gluteal level, at the tights and at the legs. At Day 0, Day 1, day 3 and Day 5

    Measured: up to 5 Days

  4. Pain as assessed by Visual Analogue Scale (VAS)

    Pain levels will be determined every 5 minutes during surgery. The Visual Analogue score (scale : 0 = no pain; 10= worst pain imaginable)

    Measured: during surgery (average 1 hour)

  5. Number of participants with low blood pressure

    Arterial blood pressure will be measured at every 2.5 minute during the first 15 minutes, then at every 5 minutes until the end of surgery. 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)

    Measured: during surgery (average 1 hour)

  6. Methemoglobinemia

    Methemoglobin level measured in umbilical cord blood of new born at the delivery

    Measured: at delivery (average 1 hour)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2018
  2. Study startFeb 2014
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03607916
Sponsor's protocol ID
B076201524085
Status last verified
Aug 2018
First submitted
24 Jul 2018
Last updated
21 Aug 2018
Results posted
No
Individual data sharing
No

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.

    PubMed 20529983

  • 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.

    PubMed 23393153

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hyperbaric prilocaine 2% and Morphine in people with Pregnant Women, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success of anesthesia (time frame: during surgery (average 1 hour)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03607916, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.

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