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

NCT07640256 | Completed Phase 4

• 1 other identifier: RET-PFC01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Proliferative Diabetic Retinopathy

Keywords

pain management; panretinal photocoagulation; proliferative diabetic retinopathy; peribulbar anesthesia

Outcome Measures

Primary Outcomes (1)

• Pain perception during PRP administration

  patient perception of pain during PRP administration in each eye, measured using the Numerical Rating Scale (NRS). The NRS measures pain intensity on a scale of 0 to 10, where 0 corresponds to the absence of pain and 10 represents the worst pain imaginable.

  Pain on the NRS scale was measured at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.

Secondary Outcomes (3)

• Heart rate

  at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.

• Respiratory rate

  at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.

• Oxygen saturation

  at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.

Study Arms (2)

Peribulbar anesthesia intervention group

EXPERIMENTAL

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% lidocaine; Drug: Tetracaine 5% drops

Control group

SHAM 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% lidocaine DRUG

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.

Peribulbar anesthesia intervention group

Tetracaine 5% drops DRUG

A single drop of topical 5% tetracaine

Control group; Peribulbar anesthesia intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older with proliferative diabetic retinopathy
• Scheduled to undergo their first PRP session
• Able to maintain the required posture at the slit lamp throughout the procedure

You may not qualify if:

• History of phobic anxiety disorder related to needles or injections
• Known allergies or hypersensitivity to lidocaine, bupivacaine, or tetracaine
• Use of analgesics within 24 hours prior to treatment
• Cognitive or motor impairments that could hinder effective communication of pain.

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead

Study Sites (1)

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

Mexico City, Mexico City, 04030, Mexico

Location

Related Publications (29)

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MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine; Lidocaine; Tetracaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• José Gerardo García Aguirre, MD

  Asociación Para Evitar la Ceguera en México, I.A.P.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 10, 2026
• Study Start: July 6, 2023
• Primary Completion: March 21, 2024
• Study Completion: June 21, 2024
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)