Anesthesia, EpiduralDOPABIEBNCT03690271
Study PIEB vs PIEB: the Dose is it Variable According to the Patients
An observational study of Anesthesia, Epidural and Pregnancy, run by Rennes University Hospital at 1 site in France.
Trial summary
the main objective of this study is to compare the effectiveness of three groups of epidurals with three different programmed intermittent epidural bolus (PIEB)settings. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anesthesia, Epidural, Pregnancy
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 17 Jan 2018
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Pregnant patient, during labor, for whom a PIEB is desired / programmed.
Who may be able to join
- Patient over 18 years old.
- Pregnant patient, during labor, live fetus, for whom a PIEB is desired / programmed.
- Patient not objecting to their participation in the study.
Who cannot join
- Hemostasis disorder contraindicated the epidural
- Eclampsia
- Caesarean section straightaway
- Patient under legal protection (guardianship, curatorship, safeguard of justice).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Programmed Intermittent Epidural Bolus (PIEB) vs PIEB: the Dose is it Variable According to the Patients
the main objective of this study is to compare the effectiveness of three groups of epidurals with three different programmed intermittent epidural bolus (PIEB)settings.
Read the detailed description
In a PIEB, the concentration of local anesthetics administered is standardized in the services according to the recommendations. What is left to the judgement of the clinician, taking care of the patient during the work, is the administered dose. This often varies according to clinician deductions that take notice of height, weight, previous pregnancies In the CHU of Rennes, three dosages are used in common practice. The objective by comparing these three dosages is to show if there is a significant difference between the groups.
- Conditions
- Anesthesia, Epidural, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Groupe 5-5 | Patients for whom the clinician has prescribed local anesthetics in the epidural: * fixed dose administered every hour in a systematic way : 5 ml * dose to be administered every hour by the patient : 5 ml | |
| groupe 6-6 | Patients for whom the clinician has prescribed local anesthetics in the epidural: * fixed dose administered every hour in a systematic way : 6 ml * dose to be administered every hour by the patient : 6 ml | |
| groupe 7-7 | Patients for whom the clinician has prescribed local anesthetics in the epidural: * fixed dose administered every hour in a systematic way :7 ml * dose to be administered every hour by the patient :7 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of additional injections during work.
Measured: two days after infclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Dec 2017
- Primary completion15 Jan 2018
- Study completion17 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, EpiduralStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric WODEY, MD, PHD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690271
- Sponsor's protocol ID
- 35RC17_3083_DOPABIEB
- Acronym
- DOPABIEB
- Status last verified
- Sep 2018
- First submitted
- 21 Sep 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Programmed Intermittent Epidural Bolus (PIEB) vs PIEB: the Dose is it Variable According to the Patients
- ClinicalTrials.gov ID
- NCT03690271
- Acronym / sponsor ID
- DOPABIEB / 35RC17_3083_DOPABIEB
- Conditions
- Anesthesia, Epidural, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 17 Jan 2018 (actual)
- First posted
- 1 Oct 2018 (actual)
- 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 main objective of this study is to compare the effectiveness of three groups of epidurals with three different programmed intermittent epidural bolus (PIEB)settings.
Detailed description
In a PIEB, the concentration of local anesthetics administered is standardized in the services according to the recommendations. What is left to the judgement of the clinician, taking care of the patient during the work, is the administered dose. This often varies according to clinician deductions that take notice of height, weight, previous pregnancies In the CHU of Rennes, three dosages are used in common practice. The objective by comparing these three dosages is to show if there is a significant difference between the groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Groupe 5-5 | – | –Patients for whom the clinician has prescribed local anesthetics in the epidural: * fixed dose administered every hour in a systematic way : 5 ml * dose to be administered every hour by the patient : 5 ml |
| groupe 6-6 | – | –Patients for whom the clinician has prescribed local anesthetics in the epidural: * fixed dose administered every hour in a systematic way : 6 ml * dose to be administered every hour by the patient : 6 ml |
| groupe 7-7 | – | –Patients for whom the clinician has prescribed local anesthetics in the epidural: * fixed dose administered every hour in a systematic way :7 ml * dose to be administered every hour by the patient :7 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Pregnant patient, during labor, for whom a PIEB is desired / programmed.
Key inclusion criteria (3 listed)
- Patient over 18 years old.
- Pregnant patient, during labor, live fetus, for whom a PIEB is desired / programmed.
- Patient not objecting to their participation in the study.
Key exclusion criteria (4 listed)
- Hemostasis disorder contraindicated the epidural
- Eclampsia
- Caesarean section straightaway
- Patient under legal protection (guardianship, curatorship, safeguard of justice).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of additional injections during work.
Time frame: two days after infclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
Related trials for Anesthesia, Epidural
Not yet recruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingPhase 2/3
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
Postdural Puncture Headache (PDPH)
Recruiting
Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient
Pregnancy
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
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.
Eric WODEY, MD, PHD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Epidural and Pregnancy, run by Rennes University Hospital 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 3 inclusion and 4 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 1 Oct 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?
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?
number of additional injections during work. (time frame: two days after infclusion). 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 1 Oct 2018.