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Completed

NCT Number: NCT02563821

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Universiy hospital

Limoges, 87000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia

Procedure

Levobupivacaine

Drug

Sufentanil

Drug

Clonidine

Drug

Epidural catheter

Device

Primary outcomes

  1. satisfaction visual analog scale (SVAS) measurment

    Time frame: 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 outcomes

  1. Number and intensity of motor block

    Time frame: procedure

    Incidence of motor block determined by number and intensity

  2. Number of call of the aneshetist for insufficient analgesia

    Time frame: procedure

    Number of call of the aneshetist for insufficient analgesia

  3. Number of doses of complementary manual bolus

    Time frame: procedure

    Number of doses of complementary manual bolus administered

  4. Obstetrical informations

    Time frame: procedure

    time of the intervention, doses of oxytocin and prostin used, instrumental delivery

  5. Numbers of Adverse events

    Time frame: procedure

    Numbers of Adverse events (Pruritus, nausea / vomitings, episodes of arterial low blood pressure)

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Acronym: PCEA-IMG

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 30, 2015
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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