Labor PainOptimEpiNCT02809742
Intermittent Ropivacaine Bolus for Epidural Labor Analgesia
An observational study of Labor Pain, run by Pierre and Marie Curie University at 1 site in France.
Trial summary
Enhanced patient safety and satisfaction have contributed to growing use of epidural labor analgesia. Epidural analgesia appears to be currently the most effective technique in reducing pain during labor. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Ropivacaine
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to 4 Jul 2019
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: healthy term primi or second gravid parturients aged 18-30 years with a singleton, live fetus in vertex presentation when in active stage of labor with cervical dilation of 3-5 cm
Who may be able to join
- healthy term primi or second gravid parturients
- aged 18-30 years
- singleton, live fetus
- vertex presentation
- active stage of labor with cervical dilation of 3-5 cm parturients
Who cannot join
- Hypertension
- no vertex presentation
- contraindications to neuraxial blockade
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Bolus Administration of Ropivacaine for Epidural Labor Analgesia : an Observational Study
Enhanced patient safety and satisfaction have contributed to growing use of epidural labor analgesia. Epidural analgesia appears to be currently the most effective technique in reducing pain during labor. However, reduction in total dose of local anesthetic and thus motor blockade is crucial to improve the obstetric outcome. This technique has evolved from intermittent boluses by anesthesiologists to the current standard labor epidural analgesic regimens in many institutions in North America and Europe that consist of a local anesthetic in combination with an opioid delivered via continuous epidural infusion (CEI) with or without patient-controlled epidural analgesia (PCEA) boluses. Recently,a new mode of administration has been used: regular bolus of low concentration local anesthetic + intermittent bolus (PIEB). This technique would offer safe and superior quality labor analgesia and greater maternal satisfaction by reducing total amount of the drug combination.
The primary outcome was to evaluate the analgesic efficacy of PIEB epidural drug delivery in terms of visual analogue scale satisfaction (VAS) score in a large cohort of patients. The secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes, total drug dose and incidence of pain that required top-up administration (breakthrough pain)
Read the detailed description
Patients were explained about the procedure and written informed consent was obtained. Healthy term primi or second gravid parturients (aged >18 years) with a singleton, live fetus in vertex presentation when in active stage of labor with cervical dilation of 3-5 cm were recruited in the study after they requested epidural for pain relief. PIEB epidural analgesia was used.
Primary outcome was maternal satisfaction during labor and delivery. Our hypothesis was that patients would have a greater level of satisfaction when using PIEB technique. The secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes.
- Conditions
- Labor Pain
- Being tested
- Ropivacaine
- Keywords
- Pregnant, Labor, Epidural, Analgesia, Intermittent
- Medical subject headings
- Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called ropivacaine 2 mg/ml
Epidural : automatic intermittent boluses associated with patient controlled bolus using ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Epidural group | Epidural : automatic intermittent boluses ( 8-12 mL per hour) + patient controlled bolus (4 mL evrey 20 min) using ropivacaine Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Analogue Satisfaction Score
VASS: 0-10: 0 = no satisfaction to 10 (total satisfaction)
Measured: 1 day
Secondary outcomes (6)
maternal hypotension
Evaluation of adverse events over epidural infusion (mean arterial pressure< 65 mmHg)
Measured: 1 day
Apgar score
The Apgar test is done by a doctor, midwife, or nurse. The health care provider examines the baby's:
- Breathing effort
- Heart rate
- Muscle tone
- Reflexes
- Skin color
Each category is scored with 0, 1, or 2, depending on the observed condition.
Measured: 1 day
Anesthetic rescue
Evaluation of the rescue performed by anesthesist over infusion
Measured: 1 day
nausea
Number of maternal nausea event
Measured: 1 day
fetal heart rate
Fetal heart sounds were monitored with a continuous Doppler machine
Measured: 1 day
Motor blockade
Bromage score for maternal motor block
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre and Marie Curie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Cuvillon, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809742
- Sponsor's protocol ID
- PMCurrieU2
- Acronym
- OptimEpi
- Status last verified
- Jul 2019
- First submitted
- 31 May 2016
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Bolus Administration of Ropivacaine for Epidural Labor Analgesia : an Observational Study
- ClinicalTrials.gov ID
- NCT02809742
- Acronym / sponsor ID
- OptimEpi / PMCurrieU2
- Conditions
- Labor Pain
- Keywords
- Pregnant, Labor, Epidural, Analgesia, Intermittent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Pierre and Marie Curie UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 22 Jun 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.
Enhanced patient safety and satisfaction have contributed to growing use of epidural labor analgesia. Epidural analgesia appears to be currently the most effective technique in reducing pain during labor. However, reduction in total dose of local anesthetic and thus motor blockade is crucial to improve the obstetric outcome. This technique has evolved from intermittent boluses by anesthesiologists to the current standard labor epidural analgesic regimens in many institutions in North America and Europe that consist of a local anesthetic in combination with an opioid delivered via continuous epidural infusion (CEI) with or without patient-controlled epidural analgesia (PCEA) boluses. Recently,a new mode of administration has been used: regular bolus of low concentration local anesthetic + intermittent bolus (PIEB). This technique would offer safe and superior quality labor analgesia and greater maternal satisfaction by reducing total amount of the drug combination.
The primary outcome was to evaluate the analgesic efficacy of PIEB epidural drug delivery in terms of visual analogue scale satisfaction (VAS) score in a large cohort of patients. The secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes, total drug dose and incidence of pain that required top-up administration (breakthrough pain)
Detailed description
Patients were explained about the procedure and written informed consent was obtained. Healthy term primi or second gravid parturients (aged >18 years) with a singleton, live fetus in vertex presentation when in active stage of labor with cervical dilation of 3-5 cm were recruited in the study after they requested epidural for pain relief. PIEB epidural analgesia was used.
Primary outcome was maternal satisfaction during labor and delivery. Our hypothesis was that patients would have a greater level of satisfaction when using PIEB technique. The secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidural group | – | Drug: RopivacaineEpidural : automatic intermittent boluses ( 8-12 mL per hour) + patient controlled bolus (4 mL evrey 20 min) using ropivacaine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- healthy term primi or second gravid parturients aged 18-30 years with a singleton, live fetus in vertex presentation when in active stage of labor with cervical dilation of 3-5 cm
Key inclusion criteria (5 listed)
- healthy term primi or second gravid parturients
- aged 18-30 years
- singleton, live fetus
- vertex presentation
- active stage of labor with cervical dilation of 3-5 cm parturients
Key exclusion criteria (3 listed)
- Hypertension
- no vertex presentation
- contraindications to neuraxial blockade
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 |
|---|---|---|
| RopivacaineAlso: ropivacaine 2 mg/mlEpidural : automatic intermittent boluses associated with patient controlled bolus using ropivacaine | Drug | Epidural group |
Primary outcome
Verbal Analogue Satisfaction Score
Time frame: 1 day
VASS: 0-10: 0 = no satisfaction to 10 (total satisfaction)
6 secondary outcomes
maternal hypotension
Time frame: 1 day
Apgar score
Time frame: 1 day
Anesthetic rescue
Time frame: 1 day
nausea
Time frame: 1 day
fetal heart rate
Time frame: 1 day
Motor blockade
Time frame: 1 day
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 8 Jul 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Labor Pain, run by Pierre and Marie Curie University 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 3 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 8 Jul 2019. 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?
Verbal Analogue Satisfaction Score (time frame: 1 day). 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 8 Jul 2019.