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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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3 August 2015 |
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Main ID: |
NCT02505841 |
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Date of registration:
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22/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Transversus Abdominis Plane Block for Laparoscopic Appendicectomy in Children
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Scientific title:
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Transversus Abdominis Plane (TAP) Block for Laparoscopic Appendicectomy in Children: Opioid Saving and Alternative in the Curarization |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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240 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02505841 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
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Phase:
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N/A
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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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Maud MM Maniora, 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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Montpellier University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient hospitalized in surgery and infantile anesthesia unit or admitted in
emergencies for an laparoscopic appendectomy surgery.
- Patient whose general state corresponds to the classification of the American Society
of Anesthesiologists (ASA) I to II
- Patient member in a national insurance scheme
Exclusion Criteria:
- Patient with drilled appendicitis or peritonitis
- Patient with a contraindication to local anesthesics
- Patient with a contraindication to TAP block
- Patient with allergies or known hypersensitivity to curare
Age minimum:
1 Year
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Laparoscopic Appendectomy
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Intervention(s)
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Other: TAP block with Ropivacaine
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Drug: Curare
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Primary Outcome(s)
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Painkiller of help consumption
[Time Frame: up to 24 hours after surgery]
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Secondary Outcome(s)
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First demand of analgesic of help
[Time Frame: up to 12 hours]
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Pain intensity after surgery
[Time Frame: up to 24 hours]
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Secondary ID(s)
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2014-A01431-46
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9488
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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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