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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02563821 |
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Date of registration:
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29/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study. |
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Date of first enrolment:
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November 5, 2015 |
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Target sample size:
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37 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02563821 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Patrick SENGES, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Limoges |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Anesthesia, Epidural
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Intervention(s)
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Drug: sufentanil
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Drug: clonidine
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Drug: Levobupivacaine
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Procedure: Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia
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Device: epidural catheter
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Primary Outcome(s)
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satisfaction visual analog scale (SVAS) measurment
[Time Frame: procedure]
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Secondary Outcome(s)
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Obstetrical informations
[Time Frame: procedure]
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Number and intensity of motor block
[Time Frame: procedure]
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Number of doses of complementary manual bolus
[Time Frame: procedure]
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Number of call of the aneshetist for insufficient analgesia
[Time Frame: procedure]
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Numbers of Adverse events
[Time Frame: procedure]
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Secondary ID(s)
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I14032 (PCEA-IMG)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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