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

University of Limoges (UL)

Status and phase: Completed; Phase 3

Conditions: Anesthesia, Epidural

Treatments: Drug: Levobupivacaine; Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia; Device: epidural catheter; Drug: sufentanil; Drug: clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02563821

I14032 (PCEA-IMG)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 37 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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37 participants in 2 patient groups

PCEA-DC

Active Comparator group

Description:

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.

Treatment:

Drug: clonidine

Drug: Levobupivacaine

Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia

Device: epidural catheter

Drug: sufentanil

PCEA-BIP

Active Comparator group

Description:

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).

Treatment:

Drug: clonidine

Drug: Levobupivacaine

Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia

Device: epidural catheter

Drug: sufentanil