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
PHASE4
64 participants
INTERVENTIONAL
2017-01-04
2018-03-31
Brief Summary
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OIH in the surgical setting is debated, and may predispose patients to higher analgesic consumption in the preoperative period, and peripheral and central sensitization. The aim of the study is to compare remifentanil-based vs non opioid analgesia (clonidine, lidocaine, ketamine) for intraoperative management of patients undergoing laparoscopic left hemicolectomy, with the hypothesis that non- opiod treated patients will have lower morphine consumption in the first 24 hours after surgery. Peripheral and central hyperalgesia will be tested with Von Frey hairs and pin-prick to evaluate acute CNS (Central Nervous System) sensitization after surgery. Acute and persistent (1 and 3 months) pain will be registered, together with any side effect and parameters of surgical rehabilitation.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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opioid
remifentanil 0,15-0,25 mcg/kg/h
Remifentanil
continuous infusion intraop
opioid free
ketamine bolus 0,5 mg/kg + infusion 0,25 mg/kg/h lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h clonidine 4 mcg/kg
Ketamine
bolus 0,5 mg/kg + infusion 0,25 mg/kg/h
Lidocaine
lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h
Clonidine
clonidine 4 mcg/kg
Interventions
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Remifentanil
continuous infusion intraop
Ketamine
bolus 0,5 mg/kg + infusion 0,25 mg/kg/h
Lidocaine
lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h
Clonidine
clonidine 4 mcg/kg
Eligibility Criteria
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Inclusion Criteria
* signed informed consent
* \>18 ys
Exclusion Criteria
* no consent
* pregnancy
* psychiatric disease
* cardiac failure, aortic or mitral valve severe stenosis
* kidney or hepatic failure
* atrio-ventricular type II block
* immunodepression
* emergency surgery
* ICU admittance
* drug or alcohol abuse
* chronic pain
18 Years
90 Years
ALL
No
Sponsors
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University of Parma
OTHER
Responsible Party
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Massimo Allegri
MD, Assistant Professor
Locations
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University Hospital
Parma, Parma, Italy
Countries
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Central Contacts
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Facility Contacts
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Bugada Dario, MD
Role: primary
Other Identifiers
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34477
Identifier Type: -
Identifier Source: org_study_id
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