Clinical trial NCT02563821: Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study. (PCEA-IMG)
Official title: Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, Epidural
Keywords: Termination of pregancy
Third trimester
Programmed intermittent epidural bolus
Continuous epidural infusion
Epidural analgesia
Legally induced abortion
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* contraindications to epidural analgesia
* opioids consumption within the last 24 hours
* patient's unwillingness
* inability to comprehend or comply with the procedure

Primary outcomes:
measure: satisfaction visual analog scale (SVAS) measurment
timeFrame: procedure
Secondary outcomes:
measure: Number and intensity of motor block
timeFrame: procedure
measure: Number of call of the aneshetist for insufficient analgesia
timeFrame: procedure
measure: Number of doses of complementary manual bolus
timeFrame: procedure
measure: Obstetrical informations
timeFrame: procedure
measure: Numbers of Adverse events
timeFrame: procedure
Other outcomes:
Locations:
city: Limoges
country: France
facility: Universiy hospital
Study officials:
affiliation: University Hospital, Limoges
name: Patrick SENGES, MD
role: PRINCIPAL_INVESTIGATOR
References: