Clonidine - Ropivacaine in Peribulbar Anesthesia (CRAPO)

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

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.

Study Overview

• Status: Completed
• Conditions: Indication for Surgery of the Posterior Segment Under Locoregional Anaesthesia
• Intervention / Treatment: Drug: 5 ml Ropivacaine 10% + physiological saline; Drug: 5 ml Ropivacaine 10% + Clonidine 1 µg/kg

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21
    • CHU Dijon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ropivacaine alone group	Drug: 5 ml Ropivacaine 10% + physiological saline
EXPERIMENTAL: Ropivacaine/Clonidine group	Drug: 5 ml Ropivacaine 10% + Clonidine 1 µg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose of ropivacaine injected 10 mg/ml: necessary to obtain complete ocular akinesia	up to 1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to achieve akinesia	up to 1 hour

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 16, 2013
• Primary Completion (ACTUAL): October 7, 2013
• Study Completion (ACTUAL): October 7, 2013

Study Registration Dates

• First Submitted: October 10, 2013
• First Submitted That Met QC Criteria: October 11, 2013
• First Posted (ESTIMATE): October 16, 2013

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 9, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Sympatholytics; Ropivacaine; Clonidine
• Other Study ID Numbers: GIRARD-BERTRAND 2013