CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled / 50 target
Drug / intervention
Peribulbar anesthesia with 0.5% bupivacaine and 2% lidocaine +1 moredrug
Likely dose
Peribulbar anesthesia with 0.5% bupivacaine and 2% lidocaine 1.5 mLfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07640256
NCT07640256Phase 4CompletedOn Track (1.4/mo)Completion was 27mo ago
CompareCT.gov

Safety and Efficacy of Peribulbar Anesthesia for Pain Management in Patients With Proliferative Diabetic Retinopathy During Panretinal Photocoagulation

Asociación para Evitar la Ceguera en México·interventional·Posted Jun 10, 2026·Updated Jun 10, 2026

In Brief

A Phase 4 clinical trial evaluating Peribulbar anesthesia with 0.5% bupivacaine and 2% lidocaine and Tetracaine 5% drops for Proliferative Diabetic Retinopathy. Completed, enrolled 50 participants across 1 site.

Detailed Summary

The purpose of this study was to compare two different anesthesia methods for pain control during panretinal photocoagulation (PRP), a type of laser surgery that treats proliferative diabetic retinopathy (PDR). The study included eyes from patients with diabetes and proliferative diabetic retinopathy who were scheduled to undergo their first PRP session. Participants were split into two groups to receive either peribulbar anesthesia, which is a type of anesthesia injected through the eyelid, or a sham injection with topical anesthesia only. Pain on a numerical scale and vital signs were recorded before and for 15 minutes during PRP. These results were compared between the two groups to determine which method delivers superior pain control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProliferative Diabetic Retinopathy
CountriesMexico
Collaborators--

Timeline

Phase 4CompletedFinished
202420252026
First PostedJun 10, 2026
Enrollment StartJul 6, 2023
Primary CompletionMar 21, 2024
Study CompletionJun 21, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 22 days ago

Arms & Interventions

Peribulbar anesthesia intervention groupexperimental

The intervention administered was topical anesthesia with peribulbar anesthesia consisting of a lidocaine and bupivacaine injection.

Drug: Peribulbar anesthesia with 0.5% bupivacaine and 2% lidocaineDrug: Tetracaine 5% drops
Control groupsham_comparator

The control group received only topical anesthesia and a sham peribulbar injection.

Drug: Tetracaine 5% drops

Interventions

Peribulbar anesthesia with 0.5% bupivacaine and 2% lidocainedrug

A mixture of 1.5 mL of 0.5% bupivacaine and 1.5 mL of 2% lidocaine was prepared in a 3 mL syringe. The peribulbar injection was administered using a 25G needle inserted horizontally through the inferior palpebral conjunctiva, directed axially over the infraorbital rim, and then angled upward to deliver the anesthetic into the orbit.

Tetracaine 5% dropsdrug

A single drop of topical 5% tetracaine