Anesthesia, EpiduralPhase 3PCEA-IMGNCT02563821
Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study. (PCEA-IMG)
A Phase 3 study testing Levobupivacaine, sufentanil and clonidine in people with Anesthesia, Epidural, run by University Hospital, Limoges at 1 site in France.
Trial summary
Background : Recently, delivery of local anaesthetics via Programmed Intermittent Epidural Bolus (PIEB) has been shown to improve labour epidural analgesia compared to delivery via Continuous Epidural Infusion (CEI). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anesthesia, Epidural
- What is being tested?
- Levobupivacaine, sufentanil and clonidine
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2015to 11 Dec 2018
- 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
- age ≥ 18 years
- ASA 1 or 2 (healthy women)
- pregnancy at third trimester
- willingness of voluntary interrupt the pregnancy
- women affiliated to french health social system
- written informed consent from every patient
Who cannot join
- contraindications to epidural analgesia
- opioids consumption within the last 24 hours
- patient's unwillingness
- inability to comprehend or comply with the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study.
Background : Recently, delivery of local anaesthetics via Programmed Intermittent Epidural Bolus (PIEB) has been shown to improve labour epidural analgesia compared to delivery via Continuous Epidural Infusion (CEI).
Purpose : However, the superiority of PIEB compared to CEI has not been investigated for third trimester voluntary termination of pregnancy.
We hypothesized that PIEB administration would result in a better degree of satisfaction of the patients compared with CEI for third trimester legally induced abortion analgesia.
Read the detailed description
Abstract : The recent technical advances in antenatal diagnosis have led to an increase number of legally induced abortion at the third trimester of pregnancy. Psychological pain is frequently associated to physical pain in these kinds of interventions. So anaesthetists are more and more involved in voluntary termination of pregnancy analgesia.
In France, Patient Controlled Epidural Analgesia (PCEA) with CEI mode is usually used for voluntary termination of pregnancy analgesia. But recent studies have shown that PIEB mode as compared to CEI mode increases maternal satisfaction during labour. This may be attributed to a more extensive spread of epidural solution when delivered as a bolus rather than continuous infusion.
Few trials have been interested in investigating the best mode of PCEA for legally induced abortion analgesia.
This study includes women who undergo voluntary third semester termination of pregnancy. Patients are randomized to PIEB or CEI for pain analgesia. In this randomized, double-blind study, the investigators assess the degree of satisfaction of the patients (primary outcome), the incidence of motor block, total drug consumption and adverse events (secondary outcomes) between the two study groups.
The different values are collected during the intervention on a specific paper for each patient and the degree of satisfaction is reported on this paper just before the patient leaves the birth room (approximatively 2 hours after the expulsion).
- Conditions
- Anesthesia, Epidural
- Being tested
- Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia, Levobupivacaine, sufentanil, clonidine, epidural catheter
- Keywords
- Termination of pregancy, Third trimester, Programmed intermittent epidural bolus, Continuous epidural infusion, Epidural analgesia, Legally induced abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesiaProcedure or surgery
LevobupivacaineDrug
sufentanilDrug
clonidineDrug
epidural catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| PCEA-DC | Active comparator | Injection of a 2 mL initial epidural loading dose consisting of a blend (10 mL) of levobupivacaine 20 mg, sufentanil 10 µg to assure the absence of motor block and so exclude intrathecal placement of the epidural catheter.
* Injection of the rest of the loading dose (8mL).
* In this group the pump is programmed to deliver a continuous infusion at 10 mL /h consisting of levobupivacaine 0,573 mg/mL, sufentanil 0,37 µg/mL, clonidine 1,38 µg/ mL. Additional 5 mL patient-activated boluses will be allowed with a lockout interval of 10 minutes.
* If the parturient feels she has inadequate analgesia after having activated the PCEA bolus twice in a thirty minutes period, an additional manual bolus of 6 mL of levobupivacaine 2,5 mg/mL will be administered until the Pain Visual Analog Scale (PVAS) is < 3/10. Receives: Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia; Drug: Levobupivacaine; Drug: sufentanil; Drug: clonidine; Device: epidural catheter |
| PCEA-BIP | Active comparator | Injection of a 2 mL initial epidural loading dose consisting of a blend (10 mL) of levobupivacaine 20 mg, sufentanil 10 µg to assure the absence of motor block and so exclude intrathecal placement of the epidural catheter.
* Injection of the rest of the loadind dose (8 mL)
* In this group the pump is programmed to deliver automated mandatory boluses of 5 mL consisting of levobupivacaine 0,573 mg/mL, sufentanil 0,37 µg/mL, clonidine 1,38 µg/mL every 30 minutes. Additional 5 mL patient-activated boluses will be allowed with a lockout interval of 10 minutes.
* If the parturient feels she has inadequate analgesia after having activated the PCEA bolus twice in a thirty minutes period, an additional manual bolus of 6 mL of levobupivacaine 2,5 mg/mL will be administered until the Pain Visual Analog Scale (PVAS) is < 3/10 (0 = no pain and 10 = insufferable pain). Receives: Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia; Drug: Levobupivacaine; Drug: sufentanil; Drug: clonidine; Device: epidural catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
satisfaction visual analog scale (SVAS) measurment
The degree of satisfaction is assessed using a satisfaction visual analog scale (SVAS) where 0 corresponded to " completely unsatisfied " and 100 to " completely satisfied ".
Measured: procedure
Secondary outcomes (5)
Number and intensity of motor block
Incidence of motor block determined by number and intensity
Measured: procedure
Number of call of the aneshetist for insufficient analgesia
Number of call of the aneshetist for insufficient analgesia
Measured: procedure
Number of doses of complementary manual bolus
Number of doses of complementary manual bolus administered
Measured: procedure
Obstetrical informations
time of the intervention, doses of oxytocin and prostin used, instrumental delivery
Measured: procedure
Numbers of Adverse events
Numbers of Adverse events (Pruritus, nausea / vomitings, episodes of arterial low blood pressure)
Measured: procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study start5 Nov 2015
- Primary completion11 Dec 2018
- Study completion11 Dec 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 University Hospital, LimogesThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick SENGES, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563821
- Sponsor's protocol ID
- I14032 (PCEA-IMG)
- Acronym
- PCEA-IMG
- Status last verified
- Jan 2019
- First submitted
- 29 Sep 2015
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study.
- ClinicalTrials.gov ID
- NCT02563821
- Acronym / sponsor ID
- PCEA-IMG / I14032 (PCEA-IMG)
- Conditions
- Anesthesia, Epidural
- Keywords
- Termination of pregancy, Third trimester, Programmed intermittent epidural bolus, Continuous epidural infusion, Epidural analgesia, Legally induced abortion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 5 Nov 2015 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 30 Sep 2015 (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.
Background : Recently, delivery of local anaesthetics via Programmed Intermittent Epidural Bolus (PIEB) has been shown to improve labour epidural analgesia compared to delivery via Continuous Epidural Infusion (CEI).
Purpose : However, the superiority of PIEB compared to CEI has not been investigated for third trimester voluntary termination of pregnancy.
We hypothesized that PIEB administration would result in a better degree of satisfaction of the patients compared with CEI for third trimester legally induced abortion analgesia.
Detailed description
Abstract : The recent technical advances in antenatal diagnosis have led to an increase number of legally induced abortion at the third trimester of pregnancy. Psychological pain is frequently associated to physical pain in these kinds of interventions. So anaesthetists are more and more involved in voluntary termination of pregnancy analgesia.
In France, Patient Controlled Epidural Analgesia (PCEA) with CEI mode is usually used for voluntary termination of pregnancy analgesia. But recent studies have shown that PIEB mode as compared to CEI mode increases maternal satisfaction during labour. This may be attributed to a more extensive spread of epidural solution when delivered as a bolus rather than continuous infusion.
Few trials have been interested in investigating the best mode of PCEA for legally induced abortion analgesia.
This study includes women who undergo voluntary third semester termination of pregnancy. Patients are randomized to PIEB or CEI for pain analgesia. In this randomized, double-blind study, the investigators assess the degree of satisfaction of the patients (primary outcome), the incidence of motor block, total drug consumption and adverse events (secondary outcomes) between the two study groups.
The different values are collected during the intervention on a specific paper for each patient and the degree of satisfaction is reported on this paper just before the patient leaves the birth room (approximatively 2 hours after the expulsion).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCEA-DC | Active comparator | Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia, Drug: Levobupivacaine, Drug: sufentanil, Drug: clonidine, Device: epidural catheterInjection of a 2 mL initial epidural loading dose consisting of a blend (10 mL) of levobupivacaine 20 mg, sufentanil 10 µg to assure the absence of motor block and so exclude intrathecal placement of the epidural catheter. * Injection of the rest of the loading dose (8mL). * In this group the pump is programmed to deliver a continuous infusion at 10 mL /h consisting of levobupivacaine 0,573 mg/mL, sufentanil 0,37 µg/mL, clonidine 1,38 µg/ mL. Additional 5 mL patient-activated boluses will be allowed with a lockout interval of 10 minutes. * If the parturient feels she has inadequate analgesia after having activated the PCEA bolus twice in a thirty minutes period, an additional manual bolus of 6 mL of levobupivacaine 2,5 mg/mL will be administered until the Pain Visual Analog Scale (PVAS) is < 3/10. |
| PCEA-BIP | Active comparator | Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia, Drug: Levobupivacaine, Drug: sufentanil, Drug: clonidine, Device: epidural catheterInjection of a 2 mL initial epidural loading dose consisting of a blend (10 mL) of levobupivacaine 20 mg, sufentanil 10 µg to assure the absence of motor block and so exclude intrathecal placement of the epidural catheter. * Injection of the rest of the loadind dose (8 mL) * In this group the pump is programmed to deliver automated mandatory boluses of 5 mL consisting of levobupivacaine 0,573 mg/mL, sufentanil 0,37 µg/mL, clonidine 1,38 µg/mL every 30 minutes. Additional 5 mL patient-activated boluses will be allowed with a lockout interval of 10 minutes. * If the parturient feels she has inadequate analgesia after having activated the PCEA bolus twice in a thirty minutes period, an additional manual bolus of 6 mL of levobupivacaine 2,5 mg/mL will be administered until the Pain Visual Analog Scale (PVAS) is < 3/10 (0 = no pain and 10 = insufferable pain). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥ 18 years
- ASA 1 or 2 (healthy women)
- pregnancy at third trimester
- willingness of voluntary interrupt the pregnancy
- women affiliated to french health social system
Key exclusion criteria (4 listed)
- contraindications to epidural analgesia
- opioids consumption within the last 24 hours
- patient's unwillingness
- inability to comprehend or comply with the procedure
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 |
|---|---|---|
| Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia | Procedure or surgery | PCEA-BIP, PCEA-DC |
| Levobupivacaine | Drug | PCEA-BIP, PCEA-DC |
| sufentanil | Drug | PCEA-BIP, PCEA-DC |
| clonidine | Drug | PCEA-BIP, PCEA-DC |
| epidural catheter | Device | PCEA-BIP, PCEA-DC |
Primary outcome
satisfaction visual analog scale (SVAS) measurment
Time frame: procedure
The degree of satisfaction is assessed using a satisfaction visual analog scale (SVAS) where 0 corresponded to " completely unsatisfied " and 100 to " completely satisfied ".
5 secondary outcomes
Number and intensity of motor block
Time frame: procedure
Number of call of the aneshetist for insufficient analgesia
Time frame: procedure
Number of doses of complementary manual bolus
Time frame: procedure
Obstetrical informations
Time frame: procedure
Numbers of Adverse events
Time frame: procedure
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 22 Jan 2019.
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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.
Patrick SENGES, MD principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levobupivacaine, sufentanil and clonidine in people with Anesthesia, Epidural, run by University Hospital, Limoges 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 6 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 22 Jan 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.
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 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?
satisfaction visual analog scale (SVAS) measurment (time frame: procedure). 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 22 Jan 2019.