Clonidine - Ropivacaine in Peribulbar Anesthesia (CRAPO)
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|ClinicalTrials.gov Identifier: NCT01963299|
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : January 10, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Indication for Surgery of the Posterior Segment Under Locoregional Anaesthesia||Drug: 5 ml Ropivacaine 10% + physiological saline Drug: 5 ml Ropivacaine 10% + Clonidine 1 µg/kg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||August 16, 2013|
|Actual Primary Completion Date :||October 7, 2013|
|Actual Study Completion Date :||October 7, 2013|
|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
- Dose of ropivacaine injected 10 mg/ml: necessary to obtain complete ocular akinesia [ Time Frame: up to 1 hour ]
- Time to achieve akinesia [ Time Frame: up to 1 hour ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963299
|Dijon, France, 21|