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Completed

NCT Number: NCT07640256

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

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.

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Key information

Conditions

Proliferative Diabetic Retinopathy Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Mexico City, 04030, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Tetracaine 5% drops

Drug

A single drop of topical 5% tetracaine

Primary outcomes

  1. Pain perception during PRP administration

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

    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.

Secondary outcomes

  1. Heart rate

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

    Heart rate measured as beats per minute using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China)

  2. Respiratory rate

    Time frame: 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 measured as breaths per minute using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China)

  3. Oxygen saturation

    Time frame: 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 was measured as SpO2 using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China)

Sponsors and collaborators

Lead sponsor

Asociación para Evitar la Ceguera en México

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 10, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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