Completed

NCT Number: NCT01963299

Clonidine - Ropivacaine in Peribulbar Anesthesia

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.

Completed

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Key information

Conditions

Indication for Surgery of the Posterior Segment Under Locoregional Anaesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Dijon

Dijon, 21, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

5 ml Ropivacaine 10% + physiological saline

Drug

5 ml Ropivacaine 10% + Clonidine 1 µg/kg

Drug

Primary outcomes

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

Time frame: up to 1 hour

Secondary outcomes

Time to achieve akinesia

Time frame: up to 1 hour

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Prospective Randomised Double-blind Study to Compare Ropivacaine 10mg/mL Alone Versus Ropivacaine 10mg/mL Associated With Clonidine 1µg/kg for Peribulbar Anesthesia in Posterior Eye Surgery

Acronym: CRAPO

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Oct 16, 2013
Registry last updated: Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.