Obstetric PainPhase 3DEXAPERNCT02857465
Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome
A Phase 3 study testing Dexamethasone, Ropivacaine and Sufentanil in people with Obstetric Pain and Other Complications of Obstetric Anesthesia - Delivered, run by Centre Hospitalier Universitaire de la Réunion.
Trial summary
To assess the efficacy of epidural dexamethasone administration, compared to placebo, in reducing local anesthetics consumption during labor epidural analgesia in parturient women Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Pain, Other Complications of Obstetric Anesthesia - Delivered
- What is being tested?
- Dexamethasone, Ropivacaine and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2017
- Phase
- Phase 3
- 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
- First and single pregnancy, Full term (> 37 wks amenorrhea), Cephalic presentation, Spontaneous labor, Epidural analgesia requested by the parturient
Who cannot join
- Minor patient, Planned cesarean section, Gestational hypertension and preeclampsia, Gestational diabetes, opioids or ocytocin administration before epidural analgesia preparation, Allergy to dexamethasone, Untreated gastroduodenal ulcer, epidural analgesia contraindications
About this study
Official title: Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome. A Randomized Double Blind Placebo Study
To assess the efficacy of epidural dexamethasone administration, compared to placebo, in reducing local anesthetics consumption during labor epidural analgesia in parturient women
Read the detailed description
It is hypothesized that reducing the consumption of local anesthetics during labor epidural analgesia could lower their side effects (rate of motor block, nausea and emesis during labor, maternal hypotension, maternal fever) and improve the duration of the second part of the labor, and the new-born adaptation to child-birth and during the first 24 hours. The use of instruments for assisted vaginal delivery and the needs to perform emergency cesarean could also be impacted.
The efficacy of the dexamethasone will be assessed by the hourly Ropivacaine consumption (milligrams/hour) measured from randomization time to the end of epidural analgesia.
- Being tested
- Dexamethasone, Placebo, Ropivacaine, Sufentanil
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexamethasone MYLAN
single epidural injection of dexamethasone (8 mg) in addition to local anesthetics used for epidural analgesia
PlaceboDrug
Also called Sodium chloride LAVOISIER 0.9 %
single epidural injection of sodium chloride 0.9% (2 mL) in addition to local anesthetics used for epidural analgesia
RopivacaineDrug
Also called NAROPEINE 7.5 mg/ml, anhydrous ropivacaine chlorhydrate
NAROPEINE 7.5 mg/mL is diluted at the concentration of 1 mg/mL prior to the epidural use. The perfused dose depends on the efficacy of analgesia in reducing the delivery labor pain.
SufentanilDrug
Also called Sufentanil Mylan 0.5 microg/mL
Sufentanil 0.5 mg/L is used as solution for injection for epidural analgesia and used in combination with ropivacaine. The administered dose is bolus of 15 to 20 micrograms diluted into 10 mL.
| Study group | Role | What they receive |
|---|---|---|
| Epidural analgesia + DEXAMETHASONE | Experimental | Single epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil) Receives: Drug: Dexamethasone; Drug: Ropivacaine; Drug: Sufentanil |
| Epidural analgesia + PLACEBO | Placebo comparator | Single epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil) Receives: Drug: Placebo; Drug: Ropivacaine; Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hourly ropivacaine consumption expressed as mg/mL used during epidural analgesia in parturient women
The administered dose of ropivacaine during epidural is used to measure the efficacy of Dexamethasone in reducing local anesthetics during labor analgesia
Measured: From the beginning to the end of epidural analgesia, that could last up to 6 hours
Secondary outcomes (4)
Improvement of epidural analgesia assessed by the reduction of adverse effects induced by local anesthetics
Adverse effects such as nausea and emesis, maternal hypotension, maternal hyperthermia will be recorded during epidural analgesia
Measured: From the beginning to the end of epidural analgesia, that could last up to 6 hours
Dexamethasone effect maternal pain during delivery assessed by Visual Analogic Scale
Evaluation of the lowered maternal pain induced by Dexamethasone
Measured: From the beginning to the end of epidural analgesia, that could last up to 6 hours
Improvement of delivery assessed by recording the number of side events (motor block, emergency cesarean, instrument-assisted delivery)
Rates of motor block, emergency cesarean, instrument-assisted delivery
Measured: From the beginning to the end of epidural analgesia, that could last up to 6 hours
Maternal satisfaction assessed by visual analogic scale
Patient satisfaction visual analogic scale
Measured: On the morning of the next day after delivery, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJan 2017 (estimated)
- Primary completionJun 2017
- Study completionJun 2017
Why it stopped: French Agency for the Safety of Health Products refusal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857465
- Sponsor's protocol ID
- 2015/CHU/12
- Acronym
- DEXAPER
- Status last verified
- Mar 2019
- First submitted
- 26 Jul 2016
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome. A Randomized Double Blind Placebo Study
- ClinicalTrials.gov ID
- NCT02857465
- Acronym / sponsor ID
- DEXAPER / 2015/CHU/12
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: French Agency for the Safety of Health Products refusal
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Jan 2017 (estimated)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 5 Aug 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.
To assess the efficacy of epidural dexamethasone administration, compared to placebo, in reducing local anesthetics consumption during labor epidural analgesia in parturient women
Detailed description
It is hypothesized that reducing the consumption of local anesthetics during labor epidural analgesia could lower their side effects (rate of motor block, nausea and emesis during labor, maternal hypotension, maternal fever) and improve the duration of the second part of the labor, and the new-born adaptation to child-birth and during the first 24 hours. The use of instruments for assisted vaginal delivery and the needs to perform emergency cesarean could also be impacted.
The efficacy of the dexamethasone will be assessed by the hourly Ropivacaine consumption (milligrams/hour) measured from randomization time to the end of epidural analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia + DEXAMETHASONE | Experimental | Drug: Dexamethasone, Drug: Ropivacaine, Drug: SufentanilSingle epidural injection of Dexamethasone Mylan (8 mg) concomitant to epidural analgesia (ropivacaine+ sufentanil) |
| Epidural analgesia + PLACEBO | Placebo comparator | Drug: Placebo, Drug: Ropivacaine, Drug: SufentanilSingle epidural injection of sodium chloride (0.9%) Lavoisier concomitant to epidural analgesia (ropivacaine + sufentanil) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First and single pregnancy, Full term (> 37 wks amenorrhea), Cephalic presentation, Spontaneous labor, Epidural analgesia requested by the parturient
Key exclusion criteria (1 listed)
- Minor patient, Planned cesarean section, Gestational hypertension and preeclampsia, Gestational diabetes, opioids or ocytocin administration before epidural analgesia preparation, Allergy to dexamethasone, Untreated gastroduodenal ulcer, epidural analgesia contraindications
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 |
|---|---|---|
| DexamethasoneAlso: Dexamethasone MYLANsingle epidural injection of dexamethasone (8 mg) in addition to local anesthetics used for epidural analgesia | Drug | Epidural analgesia + DEXAMETHASONE |
| PlaceboAlso: Sodium chloride LAVOISIER 0.9 %single epidural injection of sodium chloride 0.9% (2 mL) in addition to local anesthetics used for epidural analgesia | Drug | Epidural analgesia + PLACEBO |
| RopivacaineAlso: NAROPEINE 7.5 mg/ml, anhydrous ropivacaine chlorhydrateNAROPEINE 7.5 mg/mL is diluted at the concentration of 1 mg/mL prior to the epidural use. The perfused dose depends on the efficacy of analgesia in reducing the delivery labor pain. | Drug | Epidural analgesia + DEXAMETHASONE, Epidural analgesia + PLACEBO |
| SufentanilAlso: Sufentanil Mylan 0.5 microg/mLSufentanil 0.5 mg/L is used as solution for injection for epidural analgesia and used in combination with ropivacaine. The administered dose is bolus of 15 to 20 micrograms diluted into 10 mL. | Drug | Epidural analgesia + DEXAMETHASONE, Epidural analgesia + PLACEBO |
Primary outcome
Hourly ropivacaine consumption expressed as mg/mL used during epidural analgesia in parturient women
Time frame: From the beginning to the end of epidural analgesia, that could last up to 6 hours
The administered dose of ropivacaine during epidural is used to measure the efficacy of Dexamethasone in reducing local anesthetics during labor analgesia
4 secondary outcomes
Improvement of epidural analgesia assessed by the reduction of adverse effects induced by local anesthetics
Time frame: From the beginning to the end of epidural analgesia, that could last up to 6 hours
Dexamethasone effect maternal pain during delivery assessed by Visual Analogic Scale
Time frame: From the beginning to the end of epidural analgesia, that could last up to 6 hours
Improvement of delivery assessed by recording the number of side events (motor block, emergency cesarean, instrument-assisted delivery)
Time frame: From the beginning to the end of epidural analgesia, that could last up to 6 hours
Maternal satisfaction assessed by visual analogic scale
Time frame: On the morning of the next day after delivery, up to 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone, Ropivacaine and Sufentanil in people with Obstetric Pain and Other Complications of Obstetric Anesthesia - Delivered, run by Centre Hospitalier Universitaire de la Réunion.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Hourly ropivacaine consumption expressed as mg/mL used during epidural analgesia in parturient women (time frame: From the beginning to the end of epidural analgesia, that could last up to 6 hours). 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 7 Mar 2019.