Clonidine - Ropivacaine in Peribulbar Anesthesia (CRAPO)

University Hospital Center (CHU) Dijon Bourgogne

Status and phase

Completed

Phase 2

Conditions

Indication for Surgery of the Posterior Segment Under Locoregional Anaesthesia

Treatments

Drug: 5 ml Ropivacaine 10% + Clonidine 1 µg/kg

Drug: 5 ml Ropivacaine 10% + physiological saline

Study type

Interventional

Funder types

Other

Identifiers

NCT01963299

GIRARD-BERTRAND 2013

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).