Pain Management During Panretinal Photocoagulation for Diabetic Retinopathy: Safety and Efficacy of Peribulbar Anesthesia
8 de junio de 2026 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
50
Fase
- Fase 4
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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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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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain perception during PRP administration
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Heart rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: José Gerardo García Aguirre, MD, Asociacion Para Evitar la Ceguera en Mexico, I.A.P.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- Tsoumani AT, Asproudis IC, Damigos D. Tetracaine 0.5% eyedrops with or without lidocaine 2% gel in topical anesthesia for cataract surgery. Clin Ophthalmol. 2010 Sep 7;4:967-70. doi: 10.2147/opth.s11755.
- 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.
- Ripart J, Lefrant JY, de La Coussaye JE, Prat-Pradal D, Vivien B, Eledjam JJ. Peribulbar versus retrobulbar anesthesia for ophthalmic surgery: an anatomical comparison of extraconal and intraconal injections. Anesthesiology. 2001 Jan;94(1):56-62. doi: 10.1097/00000542-200101000-00013.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
6 de julio de 2023
Finalización primaria (Actual)
21 de marzo de 2024
Finalización del estudio (Actual)
21 de junio de 2024
Fechas de registro del estudio
Enviado por primera vez
1 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de junio de 2026
Publicado por primera vez (Actual)
10 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Manifestaciones neuroconductuales
- Trastornos de la percepción
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Agnosia
- Químicos orgánicos
- Hidrocarburos
- Hidrocarburos, cíclico
- Ácidos carboxílicos
- Hidrocarburos, aromáticos
- Aniluros
- Amidas
- Compuestos anilina
- Amina
- Acetanilidas
- Derivados de benceno
- Ácidos, carbocíclicos
- paraa-aminobenzoates
- Aminobenzoatos
- Benzoates
- Bupivacaína
- Lidocaína
- Tetracaína
Otros números de identificación del estudio
- RET-PFC01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
De-identified participant data will be made available to qualified researchers upon request to the corresponding author.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .