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

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ClinicalTrials.gov Identifier: NCT02563821
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

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.


Condition or disease Intervention/treatment Phase
Anesthesia, Epidural Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia Drug: Levobupivacaine Drug: sufentanil Drug: clonidine Device: epidural catheter Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study.
Actual Study Start Date : November 5, 2015
Actual Primary Completion Date : December 11, 2018
Actual Study Completion Date : December 11, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia
Drug: Levobupivacaine
Drug: sufentanil
Drug: clonidine
Device: epidural catheter
Active Comparator: 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).
Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia
Drug: Levobupivacaine
Drug: sufentanil
Drug: clonidine
Device: epidural catheter



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563821


Locations
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France
Universiy hospital
Limoges, France, 87000
Sponsors and Collaborators
University Hospital, Limoges
Investigators
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Principal Investigator: Patrick SENGES, MD University Hospital, Limoges
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02563821    
Other Study ID Numbers: I14032 (PCEA-IMG)
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019
Keywords provided by University Hospital, Limoges:
Termination of pregancy
Third trimester
Programmed intermittent epidural bolus
Continuous epidural infusion
Epidural analgesia
Legally induced abortion
Additional relevant MeSH terms:
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Clonidine
Sufentanil
Levobupivacaine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local