Pain Management During Panretinal Photocoagulation for Diabetic Retinopathy: Safety and Efficacy of Peribulbar Anesthesia
8 de junho de 2026 atualizado por: Asociación para Evitar la Ceguera en México
Safety and Efficacy of Peribulbar Anesthesia for Pain Management in Patients With Proliferative Diabetic Retinopathy During Panretinal Photocoagulation
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.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
50
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Mexico City
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Mexico City, Mexico City, México, 04030
- Asociacion Para Evitar la Ceguera en Mexico, I.A.P.
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Peribulbar anesthesia intervention group
The intervention administered was topical anesthesia with peribulbar anesthesia consisting of a lidocaine and bupivacaine injection.
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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.
A single drop of topical 5% tetracaine
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Comparador Falso: Control group
The control group received only topical anesthesia and a sham peribulbar injection.
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A single drop of topical 5% tetracaine
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain perception during PRP administration
Prazo: Pain on the NRS scale was measured at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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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.
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Pain on the NRS scale was measured at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Heart rate
Prazo: at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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Heart rate measured as beats per minute using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China)
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at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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Respiratory rate
Prazo: at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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Respiratory rate measured as breaths per minute using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China)
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at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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Oxygen saturation
Prazo: at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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Oxygen saturation was measured as SpO2 using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China)
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at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: José Gerardo García Aguirre, MD, Asociacion Para Evitar la Ceguera en Mexico, I.A.P.
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):766-85.
- Preliminary report on effects of photocoagulation therapy. The Diabetic Retinopathy Study Research Group. Am J Ophthalmol. 1976 Apr;81(4):383-96. doi: 10.1016/0002-9394(76)90292-0.
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- Yau JW, Rogers SL, Kawasaki R, Lamoureux EL, Kowalski JW, Bek T, Chen SJ, Dekker JM, Fletcher A, Grauslund J, Haffner S, Hamman RF, Ikram MK, Kayama T, Klein BE, Klein R, Krishnaiah S, Mayurasakorn K, O'Hare JP, Orchard TJ, Porta M, Rema M, Roy MS, Sharma T, Shaw J, Taylor H, Tielsch JM, Varma R, Wang JJ, Wang N, West S, Xu L, Yasuda M, Zhang X, Mitchell P, Wong TY; Meta-Analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012 Mar;35(3):556-64. doi: 10.2337/dc11-1909. Epub 2012 Feb 1.
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- Richardson C, Waterman H. Pain relief during panretinal photocoagulation for diabetic retinopathy: a national survey. Eye (Lond). 2009 Dec;23(12):2233-7. doi: 10.1038/eye.2008.421.
- Wu WC, Hsu KH, Chen TL, Hwang YS, Lin KK, Li LM, Shih CP, Lai CC. Interventions for relieving pain associated with panretinal photocoagulation: a prospective randomized trial. Eye (Lond). 2006 Jun;20(6):712-9. doi: 10.1038/sj.eye.6701989. Epub 2005 Jul 8.
- Ko BW, Shim JH, Lee BR, Cho HY. Analgesic effects of tramadol during panretinal photocoagulation. Korean J Ophthalmol. 2009 Dec;23(4):273-6. doi: 10.3341/kjo.2009.23.4.273. Epub 2009 Dec 4.
- Zakrzewski PA, O'Donnell HL, Lam WC. Oral versus topical diclofenac for pain prevention during panretinal photocoagulation. Ophthalmology. 2009 Jun;116(6):1168-74. doi: 10.1016/j.ophtha.2009.01.022. Epub 2009 Apr 19.
- Tesha PE, Giavedoni LR, Berger AR, Altomare F, Chow DR, Navajas EV, Yoganathan P, Wong DT, Principe A. Subconjunctival lidocaine before laser treatment: a randomized trial. Ophthalmology. 2010 Sep;117(9):1810-4. doi: 10.1016/j.ophtha.2010.01.036. Epub 2010 Jun 8.
- Stitt AW, Curtis TM, Chen M, Medina RJ, McKay GJ, Jenkins A, Gardiner TA, Lyons TJ, Hammes HP, Simo R, Lois N. The progress in understanding and treatment of diabetic retinopathy. Prog Retin Eye Res. 2016 Mar;51:156-86. doi: 10.1016/j.preteyeres.2015.08.001. Epub 2015 Aug 18.
- Teo ZL, Tham YC, Yu M, Chee ML, Rim TH, Cheung N, Bikbov MM, Wang YX, Tang Y, Lu Y, Wong IY, Ting DSW, Tan GSW, Jonas JB, Sabanayagam C, Wong TY, Cheng CY. Global Prevalence of Diabetic Retinopathy and Projection of Burden through 2045: Systematic Review and Meta-analysis. Ophthalmology. 2021 Nov;128(11):1580-1591. doi: 10.1016/j.ophtha.2021.04.027. Epub 2021 May 1.
- Tan TE, Wong TY. Diabetic retinopathy: Looking forward to 2030. Front Endocrinol (Lausanne). 2023 Jan 9;13:1077669. doi: 10.3389/fendo.2022.1077669. eCollection 2022.
- GBD 2019 Blindness and Vision Impairment Collaborators; Vision Loss Expert Group of the Global Burden of Disease Study. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. Lancet Glob Health. 2021 Feb;9(2):e144-e160. doi: 10.1016/S2214-109X(20)30489-7. Epub 2020 Dec 1.
- Gawecki M, Kicinski K, Bianco L, Battaglia Parodi M. Regression of Neovascularization after Panretinal Photocoagulation Combined with Anti-VEGF Injection for Proliferative Diabetic Retinopathy-A Review. Diagnostics (Basel). 2023 Dec 22;14(1):31. doi: 10.3390/diagnostics14010031.
- Kumar CM. Orbital regional anesthesia: complications and their prevention. Indian J Ophthalmol. 2006 Jun;54(2):77-84. doi: 10.4103/0301-4738.25826.
- Schobel HP, Ringkamp M, Behrmann A, Forster C, Schmieder RE, Handwerker HO. Hemodynamic and sympathetic nerve responses to painful stimuli in normotensive and borderline hypertensive subjects. Pain. 1996 Aug;66(2-3):117-24. doi: 10.1016/0304-3959(96)03079-5.
- McGrath PA. Psychological aspects of pain perception. Arch Oral Biol. 1994;39 Suppl:55S-62S. doi: 10.1016/0003-9969(94)90189-9.
- Duker JS, Belmont JB, Benson WE, Brooks HL Jr, Brown GC, Federman JL, Fischer DH, Tasman WS. Inadvertent globe perforation during retrobulbar and peribulbar anesthesia. Patient characteristics, surgical management, and visual outcome. Ophthalmology. 1991 Apr;98(4):519-26. doi: 10.1016/s0161-6420(91)32262-0.
- Malik A, Fletcher EC, Chong V, Dasan J. Local anesthesia for cataract surgery. J Cataract Refract Surg. 2010 Jan;36(1):133-52. doi: 10.1016/j.jcrs.2009.10.025.
- Johari M, Moallem M, Amini A, Sanie-Jahromi F. Pain Management Strategies before Pan-Retinal Photocoagulation for Diabetic Retinopathy: A Systematic Review. J Ophthalmol. 2024 Aug 20;2024:6662736. doi: 10.1155/2024/6662736. eCollection 2024.
- Gonzalez VH, Wang PW, Ruiz CQ. Panretinal Photocoagulation for Diabetic Retinopathy in the RIDE and RISE Trials: Not "1 and Done". Ophthalmology. 2021 Oct;128(10):1448-1457. doi: 10.1016/j.ophtha.2019.08.010. Epub 2019 Aug 21.
- Mafrici M, Fragiotta S, Tarsitano MG, Lorenzi U, Toscani L. Topical anesthesia versus topical and subconjunctival anesthesia combined in diabetic retinopathy photocoagulation. Eur J Ophthalmol. 2024 Mar;34(2):529-533. doi: 10.1177/11206721231199206. Epub 2023 Aug 31.
- Arruda MP, Hira S, Lima RV, Barbosa LIT, Zinher MT, Al-Sharif L, Leal Moreira JLM, Del Valle GS. Pharmacological therapy for relieving pain in panretinal photocoagulation: A network meta-analysis of randomized controlled trials. Surv Ophthalmol. 2025 Jul-Aug;70(4):645-652. doi: 10.1016/j.survophthal.2025.01.018. Epub 2025 Feb 5.
- Wang S, Hua R, Zhao Y, Liu L. Laser Treatment for Diabetic Retinopathy: History, Mechanism, and Novel Technologies. J Clin Med. 2024 Sep 13;13(18):5439. doi: 10.3390/jcm13185439.
- Shahraki T, Arabi A, Nourinia R, Beheshtizadeh NF, Entezari M, Nikkhah H, Karimi S, Ramezani A. PANRETINAL PHOTOCOAGULATION VERSUS INTRAVITREAL BEVACIZUMAB VERSUS A PROPOSED MODIFIED COMBINATION THERAPY FOR TREATMENT OF PROLIFERATIVE DIABETIC RETINOPATHY: A Randomized Three-Arm Clinical Trial (CTPDR Study). Retina. 2022 Jun 1;42(6):1065-1076. doi: 10.1097/IAE.0000000000003450.
- Chaudhary S, Zaveri J, Becker N. Proliferative diabetic retinopathy (PDR). Dis Mon. 2021 May;67(5):101140. doi: 10.1016/j.disamonth.2021.101140. Epub 2021 Feb 3. No abstract available.
- Moshfeghi A, Garmo V, Sheinson D, Ghanekar A, Abbass I. Five-Year Patterns of Diabetic Retinopathy Progression in US Clinical Practice. Clin Ophthalmol. 2020 Oct 29;14:3651-3659. doi: 10.2147/OPTH.S275968. eCollection 2020.
- Graue-Hernandez EO, Rivera-De-La-Parra D, Hernandez-Jimenez S, Aguilar-Salinas CA, Kershenobich-Stalnikowitz D, Jimenez-Corona A. Prevalence and associated risk factors of diabetic retinopathy and macular oedema in patients recently diagnosed with type 2 diabetes. BMJ Open Ophthalmol. 2020 Mar 10;5(1):e000304. doi: 10.1136/bmjophth-2019-000304. eCollection 2020.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
6 de julho de 2023
Conclusão Primária (Real)
21 de março de 2024
Conclusão do estudo (Real)
21 de junho de 2024
Datas de inscrição no estudo
Enviado pela primeira vez
1 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de junho de 2026
Primeira postagem (Real)
10 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Manifestações Neurocomportamentais
- Distúrbios Perceptivos
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Agnosia
- Produtos químicos orgânicos
- Hidrocarbonetos
- Hidrocarbonetos, cíclicos
- Ácidos carboxílicos
- Hidrocarbonetos, aromáticos
- Anilides
- Amidas
- Compostos de anilina
- Aminas
- Acetanilidas
- Derivados de benzeno
- Ácidos, carbocíclicos
- para-aminobenzóatos
- Aminobenzoates
- Benzoates
- Bupivacaína
- Lidocaína
- Tetracaína
Outros números de identificação do estudo
- RET-PFC01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
De-identified participant data will be made available to qualified researchers upon request to the corresponding author.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .