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

Anesthesia, Epidural Clinical Trial

— PCEA-IMG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563821
• Other study ID #: I14032 (PCEA-IMG)
• Status: Completed
• Phase: Phase 3
• Start date: November 5, 2015
• Est. completion date: December 11, 2018

Study information

• Verified date: January 2019
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 11, 2018
• Est. primary completion date: December 11, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Epidural

Intervention

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

Drug:
• Levobupivacaine

• sufentanil

• clonidine

Device:
• epidural catheter

Locations

Country	Name	City	State
France	Universiy hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

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