CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 56 enrolled
Drug / intervention
Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03902925
NCT03902925Phase 2Completed
CompareCT.gov

Pain During Pars Plana Vitrectomy Comparing Peribulbar Anesthesia Versus Sub-tenon Injection Plus Topical Jelly Anesthesia

University of Sao Paulo·interventional·Posted Apr 4, 2019·Updated Nov 4, 2019

In Brief

A Phase 2 clinical trial evaluating Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection and Peribulbar injection for Retinal Disease and 2 related conditions. Completed, enrolled 56 participants across 1 site.

Detailed Summary

Vitreoretinal surgery has evolved to less invasive procedures, and it is used to treat a wide range of diseases. So anesthesia for vitreoretinal procedures has evolved, promoting adequate analgesia while reducing risks to the patient. In the present study two types of procedures for anesthesia during vitreoretinal surgery are evaluated regarding the pain referred by the patient during the whole procedure: peribulbar anesthesia versus sub-tenon injection plus topical jelly anesthesia. Through the comparative analysis of the pain scale of the two groups it is expected that the two modalities present the same anesthetic efficacy, showing that the methods used may be equivalent.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetinal Disease, Diabetic Retinopathy, Maculopathy
CountriesBrazil
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 4, 2019
Enrollment StartJan 1, 2019
Primary CompletionAug 31, 2019
Study CompletionOct 31, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.2 years ago

Interventions

Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injectionprocedure

Lidocaine 2% jelly applied to conjunctival fornices for 5 minutes then injection of 2-4 ml of ropivacaine 10% in the sub-tenon space with a blunt cannula through a temporal inferior incision

Peribulbar injectionprocedure

Peribulbar injection of 4-6 ml of ropivacaine 10%