Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery
NCT ID: NCT02353702
Last Updated: 2017-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
31 participants
INTERVENTIONAL
2014-07-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Infusion of Ropivacaine during 48 hours
Evaluation of diaphragmatic function with Sniff test after 48h continuous parietal infiltration of Ropivacaine using parietal catheter at the following dose :
20 ml Bolus (7,5 mg/ml) then continuous administration of 10 ml per hour (2 mg/ml)
Sniff test
Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo
Infusion of Ropivacaine during 48 hours
20 ml Bolus (7,5 mg/ml) then continuous administration of 10 ml per hour (2 mg/ml) during 48 hours of Ropivacaine.
20 ml Bolus (NaCl 0.9 %) then continuous administration of 10 ml per hour, during 48 hours of NaCl 0.9 %.
Continuous parietal infusion with parietal catheter
Continuous parietal infiltration of Ropivacaine or placebo
NaCl
Infusion of placebo during 48 hours
Evaluation of diaphragmatic function with Sniff test after 48h continuous parietal infiltration of placebo using parietal catheter at the following dose :
20 ml Bolus (NaCl 0.9 %) then continuous administration of 10 ml per hour (NaCl 0.9 %)
Sniff test
Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo
Continuous parietal infusion with parietal catheter
Continuous parietal infiltration of Ropivacaine or placebo
Infusion of placebo during 48 hours
NaCl
Interventions
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Sniff test
Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo
Infusion of Ropivacaine during 48 hours
20 ml Bolus (7,5 mg/ml) then continuous administration of 10 ml per hour (2 mg/ml) during 48 hours of Ropivacaine.
20 ml Bolus (NaCl 0.9 %) then continuous administration of 10 ml per hour, during 48 hours of NaCl 0.9 %.
Continuous parietal infusion with parietal catheter
Continuous parietal infiltration of Ropivacaine or placebo
Infusion of placebo during 48 hours
NaCl
Eligibility Criteria
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Inclusion Criteria
* More than 18 years old , less than 80 years old
* ASA score between 1 and 3
* Effective contraception for more than 3 months in women of childbearing age
* Patients signed an informed consent
* Affiliation to a social security regimen
Exclusion Criteria
* Nasal obstruction during inclusion
* Preoperative treatment with morphine
* Need for a postoperative nasogastric tube
* Difficulty to understand the use of the PCA and/or the sniff-test
* Impossibility to place the catheter in preperitoneal position
* Pregnant women or breasting women
* Patients under guardianship
* Contraindication to use of ropivacaine
* Inclusion in another clinical trial
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Michel SCOTTE, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Rouen University Hospital
Rouen, , France
Countries
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Other Identifiers
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2012/176/HP
Identifier Type: -
Identifier Source: org_study_id
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