Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 29, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date January 22, 2019
Actual Study Start Date  ICMJE November 5, 2015
Actual Primary Completion Date December 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
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 ".
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • Number and intensity of motor block [ Time Frame: procedure ]
    Incidence of motor block determined by number and intensity
  • Number of call of the aneshetist for insufficient analgesia [ Time Frame: procedure ]
    Number of call of the aneshetist for insufficient analgesia
  • Number of doses of complementary manual bolus [ Time Frame: procedure ]
    Number of doses of complementary manual bolus administered
  • Obstetrical informations [ Time Frame: procedure ]
    time of the intervention, doses of oxytocin and prostin used, instrumental delivery
  • Numbers of Adverse events [ Time Frame: procedure ]
    Numbers of Adverse events (Pruritus, nausea / vomitings, episodes of arterial low blood pressure)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study. (PCEA-IMG)
Official Title  ICMJE Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study.
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia, Epidural
Intervention  ICMJE
  • Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia
  • Drug: Levobupivacaine
  • Drug: sufentanil
  • Drug: clonidine
  • Device: epidural catheter
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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).
    Interventions:
    • Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia
    • Drug: Levobupivacaine
    • Drug: sufentanil
    • Drug: clonidine
    • Device: epidural catheter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2019)
37
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2015)
34
Actual Study Completion Date  ICMJE December 11, 2018
Actual Primary Completion Date December 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02563821
Other Study ID Numbers  ICMJE I14032 (PCEA-IMG)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Limoges
Study Sponsor  ICMJE University Hospital, Limoges
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrick SENGES, MD University Hospital, Limoges
PRS Account University Hospital, Limoges
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP