At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effect of Retrobulbar Block on Bi-Hemispheric Cerebral Oxygen Saturation and Early Period Postoperative Cognitive Functions With Lidocaine and Levobupivacaine in Elderly Patients With Ophthalmic Surgery
In Brief
A Phase 4 clinical trial evaluating 2% lidocaine hydrochloride and 0.5% levobupivacaine for Vitreoretinal Surgery and 2 related conditions. Completed, enrolled 66 participants across 1 site.
Detailed Summary
The investigators measured changes in cerebral oxygen saturation (rSO2) and MMSE scores after retrobulbar block performed with levobupivacaine and lidocaine in patients undergoing vitreoretinal surgery.A total of 66 patients over the age of 60 undergoing vitreoretinal surgery with a total duration of less than 1 hour were included in this prospective, double-blinded study. The patients were randomly divided into two groups: group L (5ml, 2% lidocaine) and group LB (5ml, 0.5% levobupivacaine). Bilateral rSO2 measurements were recorded before the retrobulbar block and at 1-5 minutes post-block, during the procedure, and at 10-40 minutes post-op. MMSE was performed preoperatively and postoperatively in order to evaluate short term cognitive function. Sensory and motor block durations, pain, akinesia and conjunctival feeling scores, patient-surgeon satisfaction, and complications were also recorded.
Study Details
Timeline
Interventions
Retrobulbar block was performed with 5 ml of 2% lidocaine hydrochloride (AritmalR, Osel, Istanbul, Turkey) in Group L patients. The block was performed by the same practitioner (fourth year assistant of Ophthalmology Department) using inferotemporal approach as described by Sanderson using 27 gage disposable needles (Atkinson Retrobulbar NeedleR, Asico, USA)
and 5ml of 0.5% levobupivacaine (ChirocaineR, Abbvie, Chicago, USA) in Group LB patients. The block was performed by the same practitioner (fourth year assistant of Ophthalmology Department) using inferotemporal approach as described by Sanderson using 27 gage disposable needles (Atkinson Retrobulbar NeedleR, Asico, USA)