Pain Management During Panretinal Photocoagulation for Diabetic Retinopathy: Safety and Efficacy of Peribulbar Anesthesia
12 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
50
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Mexico City
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Mexico City, Mexico City, Mexique, 04030
- Asociacion Para Evitar la Ceguera en Mexico, I.A.P.
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur factice: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain perception during PRP administration
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Heart rate
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: José Gerardo García Aguirre, MD, Asociacion Para Evitar la Ceguera en Mexico, I.A.P.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
6 juillet 2023
Achèvement primaire (Réel)
21 mars 2024
Achèvement de l'étude (Réel)
21 juin 2024
Dates d'inscription aux études
Première soumission
1 juin 2026
Première soumission répondant aux critères de contrôle qualité
8 juin 2026
Première publication (Réel)
10 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies du système nerveux
- Manifestations neurocomportementales
- Troubles de la perception
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Agnosie
- Produits chimiques organiques
- Hydrocarbures
- Hydrocarbures, cyclique
- Acides carboxyliques
- Hydrocarbures, aromatique
- Anilides
- Amides
- Composés aniline
- Amines
- Acétanilides
- Dérivés de benzène
- Acides, carbocyclique
- para-aminobenzoates
- Aminobenzoates
- Benzoates
- Bupivacaïne
- Lidocaïne
- Tétracaïne
Autres numéros d'identification d'étude
- RET-PFC01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
De-identified participant data will be made available to qualified researchers upon request to the corresponding author.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .