Prilocaine or Bupivacaine for Spinal Anesthesiain Pregnant (Césarcaïne)

December 10, 2018 updated by: University Hospital, Montpellier

Comparison of the Duration of Motor Block After Spinal Anesthesia for Planned Cesarean Sections: Hyperbaric Prilocaïne Versus Hyperbaric Bupivacaine

The planned cesarean section is an intervention with a standard operating time of less than 40 minutes in trained teams. Hyperbaric Bupivacaine is the local anesthetic (LA) reference for these operations. But the duration of its motor block is generally greater than 3 hours. The purpose of this study is to show a reduction in motor block time with hyperbaric Prilocaine by at least 30 minutes, which would allow mothers and their children to return to the maternity ward earlier and thus improve the circulation of patients within the maternity's PACU.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prospective study, randomized into two parallel groups (Hyperbaric Prilocaïne versus hyperbaric Bupivacaine), double-blind, monocentric (Clinique Saint Roch in Montpellier).

The number of subjects required is 50 patients, 25 per group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Normal pregnancy
  • Scheduled caesarean section
  • Non-multiple pregnancy
  • Age of patient: 18 years and over
  • Height of patient: between 155 and 175 cm
  • Affiliated patients or beneficiaries of a Social Security System
  • Signature of the patient's consent

Exclusion criteria:

  • Patient <18 years
  • Pathological pregnancy
  • Multiple pregnancy
  • Emergency caesarean
  • Patients who cannot give informed consent (not French speaking)
  • Refusal of the patient
  • Contraindications to spinal anesthesia
  • Contraindications to Prilocaine
  • Contraindications to Bupivacaine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Hyperbaric Bupivacaine
spinal anesthesia for planned cesarean sections control group
Drug: spinal anesthesia
spinal anesthesia for planned cesarean sections
Active Comparator: Hyperbaric Prilocaïne
spinal anesthesia for planned cesarean sections
Drug: spinal anesthesia
spinal anesthesia for planned cesarean sections

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
duration of motor block
Time Frame: up to 6 hours
To compare the duration of motor block after spinal anesthesia with hyperbaric Prilocaïne versus hyperbaric Bupivacaine This evaluation is done every 15 min from the entrance to the recovery room (PACU); the motor block stops being evaluated when the modified bromination score reaches 4
up to 6 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The upper sensory level
Time Frame: 15 minutes after the LA injection
The upper sensory level obtained 15 minutes after the LA injection
15 minutes after the LA injection
Hypotensive episodes
Time Frame: 1 day
Hypotensive episodes
1 day
The time between injection and incision
Time Frame: 1 day
The time between injection and incision
1 day
The duration of the intervention
Time Frame: 1 day
The duration of the intervention
1 day
The time to return to the standard maternity ward
Time Frame: 1 day
The time to return to the standard maternity ward
1 day
APGAR score of newborns at birth
Time Frame: 1 day

APGAR score of newborns at birth. L'APGAR Apgar score is a method to quickly summarize the health of newborn children.

The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are summarized using words chosen to form a backronym (Appearance, Pulse, Grimace, Activity, Respiration).

The test is generally done at one and five minutes after birth, and may be repeated later if the score is and remains low. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.
1 day
The delay between spinal anesthesia and the first emergency analgesic injection
Time Frame: 1 day
The delay between spinal anesthesia and the first emergency analgesic injection
1 day
Assessment of pain (VAS)
Time Frame: 1 day
Pain on arrival and departure of PACU and at 24 hours. Pain will be assessedby VAS (Visual Analogue Scale); Patients rate pain on VAS from 0-10, 0 being no pain and 10 being the worst pain imaginable..
1 day
The delay between spinal anesthesia and the first injection of second-line analgesia
Time Frame: 1 day
The delay between spinal anesthesia and the first injection of second-line analgesia : delay between spinal anesthesia ans the need of rescue analgesia
1 day
The presence of neuro-sensory disorders within 24 hours postoperatively
Time Frame: 1 day
The presence of neuro-sensory disorders within 24 hours postoperatively
1 day
The presence of post lumbar puncture syndrome
Time Frame: 1 day
The presence of post lumbar puncture syndrome
1 day
score de satisfaction
Time Frame: 1 day
Patient satisfaction score at 24 hours will be assessed by VAS (Visual Analogue Scale); Patients rate satisfaction on VAS from 0-10, 0 being no satisfaction and 10 being total satisfaction
1 day
Statifaction of the Surgeon
Time Frame: 1 day
The surgeon assessed his satisfaction while the cesarien section. The surgeon satisfaction score at 24 hours will be assessed by VAS (Visual Analogue Scale); Surgeon rate satisfaction on VAS from 0-10, 0 being no satisfaction and 10 being total satisfaction.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hopital Saint Roch

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: christophe DADURE, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UF9859

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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