Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study. (PCEA-IMG)

Study Overview
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Brief Summary
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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
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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).

Official Title
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Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study.

Conditions
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Anesthesia, Epidural

Intervention / Treatment
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* Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia
* Drug: Levobupivacaine
* Drug: sufentanil
* Drug: clonidine
* Device: epidural catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PCEA-DC<br>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. | Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia<br> <br> Drug: Levobupivacaine<br> <br> Drug: sufentanil<br> <br> Drug: clonidine<br> <br> Device: epidural catheter<br> <br> |
| Active Comparator: PCEA-BIP<br>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). | Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia<br> <br> Drug: Levobupivacaine<br> <br> Drug: sufentanil<br> <br> Drug: clonidine<br> <br> Device: epidural catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and intensity of motor block | Incidence of motor block determined by number and intensity | procedure | 
| Number of call of the aneshetist for insufficient analgesia | Number of call of the aneshetist for insufficient analgesia | procedure | 
| Number of doses of complementary manual bolus | Number of doses of complementary manual bolus administered | procedure | 
| Obstetrical informations | time of the intervention, doses of oxytocin and prostin used, instrumental delivery | procedure | 
| Numbers of Adverse events | Numbers of Adverse events (Pruritus, nausea / vomitings, episodes of arterial low blood pressure) | procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Termination of pregancy, Third trimester, Programmed intermittent epidural bolus, Continuous epidural infusion, Epidural analgesia, Legally induced abortion