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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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1 June 2015 |
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Main ID: |
NCT02085902 |
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Date of registration:
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07/03/2014 |
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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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Does the Use of Ropivacaine Facilitates Cholecystectomy by Laparoscopy in Ambulatory Surgery?
VesiRop |
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Scientific title:
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Does the Use of Ropivacaine Facilitates Cholecystectomy by Laparoscopy in Ambulatory Surgery? |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02085902 |
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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, Masking: Single Blind (Outcomes Assessor)
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Phase:
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Phase 4
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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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Emeric ABET, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHD Vendée La Roche sur Yon |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Programmed Cholecystectomy
- Laparoscopy
- Man and woman
- = 18
- ASA 1 or 2
- Not living alone
- Patient receiving social security coverage
- Signature of Informed Consent Form
Exclusion Criteria:
- Cholecystectomy emergency
- Patient minor
- Pregnant woman (pregnancy test) or during breastfeeding
- Conversion to laparotomy
- Patient anticoagulant curative dose
- Living alone
- Patient addict
- Peptic Ulcer
- Refusal to enter the protocol
- Chronic requiring analgesics long-term
- Immunosuppression
- Long-term Treatment with corticosteroids
- Discovery intraoperative calculation in the bile duct
- Contraindication to ropivacaine (see cons-indications to ropivacaine)
- Hypersensitivity to study treatment or concomitant medications anesthesia
- Cardiac or unbalanced epileptic patients (due to the risk of cardiovascular and
neurological local anesthetics)
- Patients ASA = 3
- Patient <50 kg
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cholecystectomy
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Laparoscopy
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Intervention(s)
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Drug: Ropivacaine
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Primary Outcome(s)
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Time to discharge patient after surgery
[Time Frame: 6 hours postoperative]
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Secondary ID(s)
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CHD 079-13
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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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