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
PHASE2
60 participants
INTERVENTIONAL
2013-08-16
2013-10-07
Brief Summary
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The aim of the study is to prove that the association of Clonidine with Ropivacaine is more effective than ropivacaine alone for locoregional anaesthesia of the eye for retinal surgery.
The principal interest of this association of drugs is that it procures faster and longer anaesthesia of the eye with less ropivacaine (therefore fewer injections). This provides greater comfort to the patient during and after the intervention.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ropivacaine alone group
5 ml Ropivacaine 10% + physiological saline
Ropivacaine/Clonidine group
5 ml Ropivacaine 10% + Clonidine 1 µg/kg
Interventions
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5 ml Ropivacaine 10% + physiological saline
5 ml Ropivacaine 10% + Clonidine 1 µg/kg
Eligibility Criteria
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Inclusion Criteria
* any adult patient about to undergo their first operation involving the posterior segment of the eye under peribulbar anaesthesia
Exclusion Criteria
* pregnant or breast-feeding women, patients \< 18, patients who cannot give their consent, patient's refusal of Loco-Regional Anesthesia, patients who cannot remain in dorsal decubitus dorsal for at least 1h
* contra-indication for Loco-Regional Anesthesia
* hypersensitivity to the study drugs (ropivacaine, clonidine), to the corresponding excipients or hypersensitivity to local anaesthetics other than amide-type ropivacaine.
* disorders of periorbital or oculomotor sensitivity, patients with glaucoma, patients with chronic pain and on morphines
* uncontrolled arterial hypertension, clonidine per os at home, arterial hypotension before the intervention (SAP \< 90 mmHg)
* Surgery for diabetic retinopathy, patients with unbalanced diabetes, eye with prior posterior segment surgery
* Contra-indications mentioned on the summary of product characteristics for clonidine (known hypersensitivity to the active ingredients or one of its excipients, Heart rate below 60bpm, severe Bradycardia due to sinoatrial node disease or second or third degree atrioventricular block, Depression, Sultopride).
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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CHU Dijon
Dijon, , France
Countries
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Other Identifiers
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GIRARD-BERTRAND 2013
Identifier Type: -
Identifier Source: org_study_id
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