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COMPLETED
NCT07640256
PHASE4

Pain Management During Panretinal Photocoagulation for Diabetic Retinopathy: Safety and Efficacy of Peribulbar Anesthesia

Sponsor: Asociación para Evitar la Ceguera en México

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-07-06

Completion Date

2024-06-21

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

DRUG

Peribulbar anesthesia with 0.5% bupivacaine and 2% lidocaine

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.

DRUG

Tetracaine 5% drops

A single drop of topical 5% tetracaine

Locations (1)

Asociacion Para Evitar la Ceguera en Mexico, I.A.P.

Mexico City, Mexico City, Mexico