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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UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2017-08-01
2019-05-01
Brief Summary
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Investigators hypothesized that peroperative intravenous lidocaine could decrease postoperative opioid consumption and improve postoperative recovery
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Detailed Description
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Exclusion: contra-indications for any aminoamide local anesthetic (allergy, severe hepatic disease) and for intravenous lidocaine (porphyria, atrioventricular conduction disturbances, uncontrolled seizure disease), long term opioid consumption, need for a post-operative follow-up in an intensive care unit, combined surgical procedure excepting cholecystectomy, pregnancy.
Patients will be randomly allocated to receive either a saline placebo or lidocaine continuous infusions during surgery. Morphinic consumption will be assessed from the end of the procedure until the third day after surgery. Secondary criteria will concern post-operative recovery, pain and postoperative nausea and vomiting, other medical and surgical complications, and toxicity. Plasma lidocaine concentrations will be measured in patients who had received lidocaine in order to determine the safety and efficiency of our infusion protocol.
Our analysis will be a superiority one, alpha risk is 5% and beta risk is 20%, in intention to treat, with no intermediate analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control
intravenous isotonic saline administration : bolus of 0.075 ml/kg (adjusted body weight) at induction of anesthesia followed by a continuous infusion (0.1 ml/kg/h, adjusted body weight) until the end of surgery decrease to 0.05 ml/kg (adjusted body weight) during 60 min in post anesthesia care unit.
Speed of infusion were calculated to be equivalent to that of lidocaine speed of injection.
isotonic saline
intravenous isotonic saline
Lidocaine
Intravenous Lidocaine (20mg/ml) : bolus of 1.5 mg/kg (adjusted body weight) at induction of anesthesia followed by a continuous infusion (2.0 mg/kg/h, adjusted body weight) until the end of surgery decrease to 1.0 mg/kg (adjusted body weight) during 60 min in post anesthesia care unit.
Lidocaine
intravenous lidocaine versus placebo
Interventions
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Lidocaine
intravenous lidocaine versus placebo
isotonic saline
intravenous isotonic saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* pregnancy
* ASA class 4
* psychiatric disorder
* chronic opioid consumption
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Caen
OTHER
Responsible Party
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Locations
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University Hospital of Caen
Caen, , France
Countries
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Central Contacts
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fabien chaillot
Role: CONTACT
Other Identifiers
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17-014
Identifier Type: -
Identifier Source: org_study_id
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