Clonidine - Ropivacaine in Peribulbar Anesthesia

Condition(s) targeted: Indication for Surgery of the Posterior Segment Under Locoregional Anaesthesia

Intervention: 5 ml Ropivacaine 10% + physiological saline (Drug); 5 ml Ropivacaine 10% + Clonidine 1 µg/kg (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Centre Hospitalier Universitaire Dijon

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.

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome: Time to achieve akinesia

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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).

CHU Dijon, Dijon 21, France

Starting date: August 2013
Last updated: October 11, 2013