Anesthesia, Epidural
Conditions
Keywords
Termination of pregancy, Third trimester, Programmed intermittent epidural bolus, Continuous epidural infusion, Epidural analgesia, Legally induced abortion
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).
Interventions
DEVICEepidural catheter
DRUGclonidine
PROCEDUREPatient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia
DRUGLevobupivacaine
DRUGsufentanil
Sponsors
University Hospital, Limoges
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| satisfaction visual analog scale (SVAS) measurment | 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 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and intensity of motor block | procedure | Incidence of motor block determined by number and intensity |
| Number of call of the aneshetist for insufficient analgesia | procedure | Number of call of the aneshetist for insufficient analgesia |
| Number of doses of complementary manual bolus | procedure | Number of doses of complementary manual bolus administered |
| Obstetrical informations | procedure | time of the intervention, doses of oxytocin and prostin used, instrumental delivery |
| Numbers of Adverse events | procedure | Numbers of Adverse events (Pruritus, nausea / vomitings, episodes of arterial low blood pressure) |
Countries
France
Outcome results
None listed