DeliveryFREE BOLINCT03407209
Compared Efficacy of Patient-controlled Epidural Analgesia With or Without Automatic Boluses
A study testing consumption of local anesthetic measurement in people with Delivery, run by University Hospital, Caen at 1 site in France.
Trial summary
Epidural analgesia is a significant feature of the everyday experience of the delivery room. Its benefits on the maternal experience and in terms of security has been widely demonstrated. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Delivery
- What is being tested?
- consumption of local anesthetic measurement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 462 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2016to 1 Jan 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
- Informed consent
- Age >/= 18 years
- Nulliparous
- >35 weeks of amenorrhea
- In spontaneous or triggered labor
Who cannot join
- Contraindication for epidural analgesia (pre-partum hemostasis troubles, infection)
- Multiple pregnancy
- Fetal death in utero
- Programmed or in emergency caesarian
Trial locations and contacts
1 site in 1 country.
About this study
Epidural analgesia is a significant feature of the everyday experience of the delivery room. Its benefits on the maternal experience and in terms of security has been widely demonstrated.
However, some women under epidural analgesia have experienced motor block, which has been found to contribute in the lengthening of the duration of labor, dystocia and instrumental delivery. Therefore, in recent years, reducing these side effects by modifying local anesthetics, concentration of local anesthetic and injected volume has been a priority, with one aim: optimize analgesia without motor blockage.
Read more
Although epidural analgesia was first provided by continuous epidural infusion, the efficacy of intermittent epidural bolus has been demonstrated. Small regularly spaced intermittent boluses lead to a more extensive and symmetrical spread of local anesthetic in the epidural space. These findings have led to a new kind of administration combining epidural intermittent boluses with patient-controlled boluses called PEIB (Patient Epidural Intermittent Bolus). On clinical grounds, PEIB is associated with reduced local anesthetic consumption and higher maternal satisfaction.
While PEIB is experimentally and clinically approved, incidence of maternal motor block and instrumental vaginal delivery don't decrease significantly with this programming. We hypothesized that automatic intermittent boluses can lead to an accumulation of local anesthetic overlapping with patient bolus. This accumulation can be the source of motor block, dystocia and instrumental delivery. Therefore, we propose to lead a monocentric prospective randomized study upon 308 patients in order to compare PEIB to epidural analgesia totally controlled by the patient. We expect a lower consumption of local anesthetic and a lower incidence of motor block, dystocia and instrumental delivery with the free automatic bolus programming.
Read the detailed description
Local anesthetic used: levobupivacaine 0,625mg/ml
Solution prepared with 200 ml of levobupivacaine 0,625mg/ml associated with analgesic adjuvants: sufentanyl 50 micrograms and clonidine 75 micrograms.
Randomization between:
- PEIB:
- automatic hourly bolus: 8ml (5mg) on 3 min
- patient controlled bolus: 8ml (5mg) on 3 min
- refractory period: 8min
- continuous infusion: 0
- maximum dose: 65mg/4h or
- FREE programming: epidural analgesia totally controlled by the patient
- automatic hourly bolus: 0
- patient controlled bolus: 8ml (5mg) on 3 min
- refractory period: 8min
- continuous infusion: 0
- maximum dose: 65mg/4h
Supervision and care consistent with french expert conference of the SFAR (Société Française d'Anesthésie-Réanimation) on management of women under epidural analgesia.
- Conditions
- Delivery
- Being tested
- consumption of local anesthetic measurement
- Keywords
- Epidural analgesia, Patient Controlled Epidural Analgesia (PCEA), Patient Epidural Intermittent Bolus (PEIB), Local anesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consumption of local anesthetic measurementOther
consumption of local anesthetic measurement in both groups
| Study group | Role | What they receive |
|---|---|---|
| PEIB - Use of local levobupivacaine anesthetics: 0.625 mg / ml | Sham comparator | * automatic hourly bolus: 8ml (5mg) on 3 min
* patient controlled bolus: 8ml (5mg) on 3 min
* refractory period: 8min
* continuous infusion: 0
* maximum dose: 65mg/4h Receives: Other: consumption of local anesthetic measurement |
| FREE programming - levobupivacaine anesthetics: 0.625 mg / ml | Experimental | Epidural analgesia totally controlled by the patient
* automatic hourly bolus: 0
* patient controlled bolus: 8ml (5mg) on 3 min
* refractory period: 8min
* continuous infusion: 0
* maximum dose: 65mg/4h Receives: Other: consumption of local anesthetic measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of local anesthetic
Measured: during delivery
Secondary outcomes (7)
Incidence of motor block
Measured: during delivery
Incidence of dystocia
Measured: during delivery
Incidence of instrumental delivery
Measured: during delivery
Incidence of caesarian
Measured: during delivery
Incidence of oxytocin administration
Measured: during delivery
the evaluation of pain by a numerical scale rated from 0 to 10
Measured: during delivery
Patient satisfaction with Likert type scale from A: excellent to E: catastrophic for the overall experience
Measured: during delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start6 Nov 2016
- Primary completion16 Aug 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliveryStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407209
- Sponsor's protocol ID
- 2016-A01346-45
- Acronym
- FREE BOLI
- Status last verified
- Jan 2018
- First submitted
- 7 Mar 2017
- Last updated
- 23 Jan 2018
- 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 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compared Efficacy of Patient-controlled Epidural Analgesia With or Without Automatic Boluses
- ClinicalTrials.gov ID
- NCT03407209
- Acronym / sponsor ID
- FREE BOLI / 2016-A01346-45
- Conditions
- Delivery
- Keywords
- Epidural analgesia, Patient Controlled Epidural Analgesia (PCEA), Patient Epidural Intermittent Bolus (PEIB), Local anesthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 6 Nov 2016 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 23 Jan 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.
Epidural analgesia is a significant feature of the everyday experience of the delivery room. Its benefits on the maternal experience and in terms of security has been widely demonstrated.
However, some women under epidural analgesia have experienced motor block, which has been found to contribute in the lengthening of the duration of labor, dystocia and instrumental delivery. Therefore, in recent years, reducing these side effects by modifying local anesthetics, concentration of local anesthetic and injected volume has been a priority, with one aim: optimize analgesia without motor blockage.
Although epidural analgesia was first provided by continuous epidural infusion, the efficacy of intermittent epidural bolus has been demonstrated. Small regularly spaced intermittent boluses lead to a more extensive and symmetrical spread of local anesthetic in the epidural space. These findings have led to a new kind of administration combining epidural intermittent boluses with patient-controlled boluses called PEIB (Patient Epidural Intermittent Bolus). On clinical grounds, PEIB is associated with reduced local anesthetic consumption and higher maternal satisfaction.
While PEIB is experimentally and clinically approved, incidence of maternal motor block and instrumental vaginal delivery don't decrease significantly with this programming. We hypothesized that automatic intermittent boluses can lead to an accumulation of local anesthetic overlapping with patient bolus. This accumulation can be the source of motor block, dystocia and instrumental delivery. Therefore, we propose to lead a monocentric prospective randomized study upon 308 patients in order to compare PEIB to epidural analgesia totally controlled by the patient. We expect a lower consumption of local anesthetic and a lower incidence of motor block, dystocia and instrumental delivery with the free automatic bolus programming.
Detailed description
Local anesthetic used: levobupivacaine 0,625mg/ml
Solution prepared with 200 ml of levobupivacaine 0,625mg/ml associated with analgesic adjuvants: sufentanyl 50 micrograms and clonidine 75 micrograms.
Randomization between:
- PEIB:
- automatic hourly bolus: 8ml (5mg) on 3 min
- patient controlled bolus: 8ml (5mg) on 3 min
- refractory period: 8min
- continuous infusion: 0
- maximum dose: 65mg/4h or
- FREE programming: epidural analgesia totally controlled by the patient
- automatic hourly bolus: 0
- patient controlled bolus: 8ml (5mg) on 3 min
- refractory period: 8min
- continuous infusion: 0
- maximum dose: 65mg/4h
Supervision and care consistent with french expert conference of the SFAR (Société Française d'Anesthésie-Réanimation) on management of women under epidural analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEIB - Use of local levobupivacaine anesthetics: 0.625 mg / ml | Sham comparator | Other: consumption of local anesthetic measurement* automatic hourly bolus: 8ml (5mg) on 3 min * patient controlled bolus: 8ml (5mg) on 3 min * refractory period: 8min * continuous infusion: 0 * maximum dose: 65mg/4h |
| FREE programming - levobupivacaine anesthetics: 0.625 mg / ml | Experimental | Other: consumption of local anesthetic measurementEpidural analgesia totally controlled by the patient * automatic hourly bolus: 0 * patient controlled bolus: 8ml (5mg) on 3 min * refractory period: 8min * continuous infusion: 0 * maximum dose: 65mg/4h |
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)
- Informed consent
- Age >/= 18 years
- Nulliparous
- >35 weeks of amenorrhea
- In spontaneous or triggered labor
Key exclusion criteria (4 listed)
- Contraindication for epidural analgesia (pre-partum hemostasis troubles, infection)
- Multiple pregnancy
- Fetal death in utero
- Programmed or in emergency caesarian
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 |
|---|---|---|
| consumption of local anesthetic measurementconsumption of local anesthetic measurement in both groups | Other | FREE programming - levobupivacaine anesthetics: 0.625 mg / ml, PEIB - Use of local levobupivacaine anesthetics: 0.625 mg / ml |
Primary outcome
consumption of local anesthetic
Time frame: during delivery
7 secondary outcomes
Incidence of motor block
Time frame: during delivery
Incidence of dystocia
Time frame: during delivery
Incidence of instrumental delivery
Time frame: during delivery
Incidence of caesarian
Time frame: during delivery
Incidence of oxytocin administration
Time frame: during delivery
the evaluation of pain by a numerical scale rated from 0 to 10
Time frame: during delivery
Patient satisfaction with Likert type scale from A: excellent to E: catastrophic for the overall experience
Time frame: during delivery
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 23 Jan 2018.
- 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?
A study testing consumption of local anesthetic measurement in people with Delivery, run by University Hospital, Caen 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 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 23 Jan 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. 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.
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?
consumption of local anesthetic (time frame: during delivery). 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 23 Jan 2018.