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

NCT ID: NCT02563821

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-05
• Study Completion Date: 2018-12-11

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).

Conditions

Anesthesia, Epidural

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PCEA-DC

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.

Group Type: ACTIVE_COMPARATOR

Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia

Intervention Type: PROCEDURE

Levobupivacaine

Intervention Type: DRUG

sufentanil

Intervention Type: DRUG

clonidine

Intervention Type: DRUG

epidural catheter

Intervention Type: DEVICE

PCEA-BIP

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).

Group Type: ACTIVE_COMPARATOR

Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia

Intervention Type: PROCEDURE

Levobupivacaine

Intervention Type: DRUG

sufentanil

Intervention Type: DRUG

clonidine

Intervention Type: DRUG

epidural catheter

Intervention Type: DEVICE

Interventions

Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia

Intervention Type: PROCEDURE

Levobupivacaine

Intervention Type: DRUG

sufentanil

Intervention Type: DRUG

clonidine

Intervention Type: DRUG

epidural catheter

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick SENGES, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

Universiy hospital

Limoges, , France

Countries

France

Other Identifiers

I14032 (PCEA-IMG)

Identifier Type: -

Identifier Source: org_study_id