CompletedPhase 2

Clonidine - Ropivacaine in Peribulbar Anesthesia

France60 participantsStarted 2013-08-16

Plain-language summary

This is a study conducted in 60 patients, randomly assigned to one of two groups of 30: the first will receive ropivacaine alone and the second will receive the association ropivacaine/clonidine. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients who have given written informed consent * any adult patient about to undergo their first operation involving the posterior segment of the eye under peribulbar anaesthesia Exclusion Criteria: * persons without National Health Insurance * 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose of ropivacaine injected 10 mg/ml: necessary to obtain complete ocular akinesia

Timeframe: up to 1 hour

Trial details

NCT IDNCT01963299

SponsorCentre Hospitalier Universitaire Dijon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-10-07

View on ClinicalTrials.gov More Indication for Surgery of the Posterior Segment Under Locoregional Anaesthesia trials