Pregnant Women>37SAEpiConCESNCT02895022
EpiConCES - Epidural Lidocaine for Conversion to CaEsarean Section
A study testing Lidocaine 2% adrénalinée, Epidural catheter and Caesarean section in people with Pregnant Women>37SA, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The need to resort to a midwifery course work in cesarean is a common practice. Epidural analgesia for labor analgesia is practiced in 90% of women in obstetric work, as when the cesarean decision is taken course work in practice and the recommendations are to use the epidural catheter in place to convert the epidural… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Women>37SA
- What is being tested?
- Lidocaine 2% adrénalinée, Epidural catheter and Caesarean section
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2016to 31 Dec 2018
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant > 37SA
- Between 150 and 190cm
- IMC between 20 and 40
- Single pregnancy
- Elective cesarean indication during obstetric labor
Who cannot join
- Presentation of siege
- Extreme and semi emergency caesarean indication
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Martine BONNIN
About this study
Official title: Determination of ED95 of 2% Lidocaine With Epinephrine for Converting Analgesia Epidural Anesthesia in Surgical Epidural in the Labor Current Cesarean
The need to resort to a midwifery course work in cesarean is a common practice. Epidural analgesia for labor analgesia is practiced in 90% of women in obstetric work, as when the cesarean decision is taken course work in practice and the recommendations are to use the epidural catheter in place to convert the epidural analgesia in epidural anesthesia by re-injecting a local anesthetic on the catheter. General anesthesia is reserved only cases of extreme urgency and cons-indications for regional anesthesia as a purveyor of high maternal morbidity and mortality.
The initial assumption is that the 2% lidocaine with epinephrine is the optimal and recommended local anesthetic solution.
Read the detailed description
There is a real variability in the volume administered by practitioners repository fault.
The main objective is to determine the ED95 dose of 2% lidocaine with epinephrine injected into the epidural catheter for which it does not arise from failure to surgical anesthesia for cesarean during labor.
The secondary objectives are to determine the failure risk factors, the hemodynamic consequences related to the volume administered and evaluate maternal satisfaction.
- Conditions
- Pregnant Women>37SA
- Being tested
- Lidocaine 2% adrénalinée, Epidural catheter, Caesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% adrénalinéeDrug
Epidural catheterDevice
Caesarean sectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine 2% adrénalinée | Experimental | The main objective is to determine the ED95 dose of 2% lidocaine with epinephrine injected into the epidural catheter for which it does not arise from failure to surgical anesthesia for cesarean during labor. Receives: Drug: Lidocaine 2% adrénalinée; Device: Epidural catheter; Procedure: Caesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or failure of lidocaine 2% with epinephrine dose administered
Measured: at day 1
Secondary outcomes (11)
Study tolerance of epidural anesthesia for caesarean section
Study tolerance - including hemodynamics - of epidural anesthesia for caesarean section depending on the dose of 2% lidocaine with epinephrine administered.
Measured: at day 1
maternal pain (Visual Analog Scale)
Measured: at day 1
maternal satisfaction
Measured: at day 1
nausea and vomiting intraoperatively
Measured: at day 1
blood pressure (PAM, PAS (mmHg))
Measured: at day 1
fluid replacement (ml)
Measured: at day 1
hypotension
Measured: at day 1
necessary to use vasopressors
Measured: at day 1
Apgar score
Measured: at day 1
fetal arterial and venous cord pH
Measured: at day 1
Intravenous sedation for inadequate anesthesia
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start5 Sep 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant Women>37SAStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine BONNIN, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895022
- Sponsor's protocol ID
- CHU-0271
- Other IDs
- 2016-000224-26, 2016
- Acronym
- EpiConCES
- Status last verified
- Feb 2018
- First submitted
- 4 Jul 2016
- Last updated
- 28 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of ED95 of 2% Lidocaine With Epinephrine for Converting Analgesia Epidural Anesthesia in Surgical Epidural in the Labor Current Cesarean
- ClinicalTrials.gov ID
- NCT02895022
- Acronym / sponsor ID
- EpiConCES / CHU-0271
- Conditions
- Pregnant Women>37SA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 5 Sep 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The need to resort to a midwifery course work in cesarean is a common practice. Epidural analgesia for labor analgesia is practiced in 90% of women in obstetric work, as when the cesarean decision is taken course work in practice and the recommendations are to use the epidural catheter in place to convert the epidural analgesia in epidural anesthesia by re-injecting a local anesthetic on the catheter. General anesthesia is reserved only cases of extreme urgency and cons-indications for regional anesthesia as a purveyor of high maternal morbidity and mortality.
The initial assumption is that the 2% lidocaine with epinephrine is the optimal and recommended local anesthetic solution.
Detailed description
There is a real variability in the volume administered by practitioners repository fault.
The main objective is to determine the ED95 dose of 2% lidocaine with epinephrine injected into the epidural catheter for which it does not arise from failure to surgical anesthesia for cesarean during labor.
The secondary objectives are to determine the failure risk factors, the hemodynamic consequences related to the volume administered and evaluate maternal satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lidocaine 2% adrénalinée | Experimental | Drug: Lidocaine 2% adrénalinée, Device: Epidural catheter, Procedure: Caesarean sectionThe main objective is to determine the ED95 dose of 2% lidocaine with epinephrine injected into the epidural catheter for which it does not arise from failure to surgical anesthesia for cesarean during labor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant > 37SA
- Between 150 and 190cm
- IMC between 20 and 40
- Single pregnancy
- Elective cesarean indication during obstetric labor
Key exclusion criteria (2 listed)
- Presentation of siege
- Extreme and semi emergency caesarean indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 2% adrénalinée | Drug | Lidocaine 2% adrénalinée |
| Epidural catheter | Device | Lidocaine 2% adrénalinée |
| Caesarean section | Procedure or surgery | Lidocaine 2% adrénalinée |
Primary outcome
Success or failure of lidocaine 2% with epinephrine dose administered
Time frame: at day 1
11 secondary outcomes
Study tolerance of epidural anesthesia for caesarean section
Time frame: at day 1
maternal pain (Visual Analog Scale)
Time frame: at day 1
maternal satisfaction
Time frame: at day 1
nausea and vomiting intraoperatively
Time frame: at day 1
blood pressure (PAM, PAS (mmHg))
Time frame: at day 1
fluid replacement (ml)
Time frame: at day 1
hypotension
Time frame: at day 1
necessary to use vasopressors
Time frame: at day 1
Apgar score
Time frame: at day 1
fetal arterial and venous cord pH
Time frame: at day 1
Intravenous sedation for inadequate anesthesia
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine BONNIN principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 2% adrénalinée, Epidural catheter and Caesarean section in people with Pregnant Women>37SA, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Feb 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 France. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success or failure of lidocaine 2% with epinephrine dose administered (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2018.