Use of gabapentin in management of postoperative pain after crosslinking / Uso da gabapentina no manejo da dor pós-operatória do crosslinking

ABSTRACT Objective: The objective was to evaluate the efficacy of gabapentin in the management of neuropathic pain in patients with keratoconus, who were treated with fast (10 minutes) epi-off corneal crosslinking (CXL). Methods: This was a prospective, double-blind, randomized study. The sample comprised patients with bilateral progressive keratoconus, aged 12 years or older, who underwent a bilateral epi-off corneal CXL (fast - 10 minutes) procedure. One group was given placebo orally, and the other group received gabapentin 600 mg orally, both preoperatively. The visual analogue scale (VAS) was applied to record postoperative pain up to 48 hours after procedure. The study was conducted at the Belotto Stock Centro Oftalmológico, in the city of Joaçaba, Santa Catarina, Brazil, from June 2018 to September 2019. Results: At no point in the study significant differences were observed between groups, in terms of pain intensity measured by means of the VAS questionnaire, or of opioid use (Paco®), though opioid consumption was 21% lower in the group receiving gabapentin. Conclusion: We concluded gabapentin has no efficacy in postoperative pain control after epi-off corneal CXL (fast - 10 minutes). Although there was no statistically significant difference, the group that received gabapentin suffered less pain, resulting in lower opioid consumption. UTN number: U1111-1256-0330.

RESUMO Objetivo: Avaliar a eficácia do uso da gabapentina no manejo da dor neuropática em pacientes portadores de ceratocone submetidos ao tratamento de crosslinking corneano epi-off fast de 10 minutos. Métodos: Tratou-se de pesquisa prospectiva, duplo-cega, randomizada. A amostra foi composta de pacientes com ceratocone progressivo bilateral, a partir dos 12 anos de idade, submetidos ao procedimento de crosslinking corneano acelerado epi-off fast de 10 minutos bilateral. Um grupo recebeu placebo via oral e o outro, gabapentina 600mg, via oral, ambos no pré-operatório. A Escala Visual Analógica foi aplicada para registrar a dor pós-operatória até 48 horas após o procedimento. A pesquisa foi realizada no período de junho de 2018 a setembro de 2019 em um centro oftalmológico. Resultados: Não foram observadas diferenças estatísticas significativas para ambos os grupos, tanto na intensidade da dor medida pela Escala Visual Analógica, como na redução do uso do opioide (Paco®), em qualquer horário analisado durante um período de 48 horas. No entanto, houve redução de 21% no consumo de opioides pelo grupo que fez uso da gabapentina. Conclusão: A gabapentina não demonstrou eficácia no controle da dor no pós-operatório do crosslinking corneano epi-off fast de 10 minutos. No entanto, observou-se que, mesmo não havendo diferença estatisticamente significativa, houve diminuição da dor no grupo em que foi usada a gabapentina, resultando na redução do consumo de opioides. Número UTN: U1111-1256-0330.

Codeine Plus Acetaminophen for Pain After Photorefractive Keratectomy: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial.

BACKGROUND: Pain after photorefractive keratectomy (PRK) is significant, and the analgesic efficacy and safety of oral opioids in combination with acetaminophen has not been fully investigated in PRK trials. PURPOSE: To assess the efficacy and safety of the combination of codeine plus acetaminophen (paracetamol) versus placebo as an add-on therapy for pain control after PRK. STUDY DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Single tertiary center. METHODS: One eye was randomly allocated to the intervention, whereas the fellow eye was treated with a placebo. Eyes were operated 2 weeks apart. The participants were adults older than 20 years with refractive stability for ≥1 year, who underwent PRK for correction of myopia or myopic astigmatism. Codeine (30 mg) plus acetaminophen (500 mg) was given orally 4 times per day for 4 days after PRK. The follow-up duration was 4 months. The study outcomes included pain scores at 1 to 72 hours, as measured by the visual analog scale, McGill Pain Questionnaire, and Brief Pain Inventory, as well as adverse events and corneal wound healing. RESULTS: Of the initial 82 eyes, 80 completed the trial (40 intervention, 40 placebo). Median (interquartile range) pain scores as measured by the visual analog scale were statistically and clinically lower during treatment with codeine/acetaminophen compared with the placebo: 1 hour: 4 (2-4) versus 6 (3-6), P < 0.001; 24 hours: 4 (3-6) versus 7 (6-9), P < 0.001; 48 hours: 1 (0-2) versus 3 (2-5), P < 0.001; and 72 hours: 0 (0-0) versus 0 (0-2), P = 0.001. Virtually identical results were obtained by the McGill Pain Questionnaire and Brief Pain Inventory scales. The most common adverse events with codeine/acetaminophen were drowsiness (42%), nausea (18%), and constipation (5%). No case of delayed epithelial healing was observed in both treatment arms. CONCLUSIONS: When added to the usual care therapy, the oral combination of codeine/acetaminophen was safe and significantly superior to the placebo for pain control after PRK. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02625753.

Efficacy of a fixed combination of 0.09 % xanthan gum/0.1 % chondroitin sulfate preservative free vs polyethylene glycol/propylene glycol in subjects with dry eye disease: a multicenter randomized controlled trial.

BACKGROUND: Dry eye disease (DED) is multifactorial, affecting 5-34 % of the global adult population and reducing quality of life. The artificial tears or lubricants are the therapy most used for the treatment of DED, due to their low side effect profile, which attempt to modify the properties of the tear film. The aim of the present study was to evaluate the clinical efficacy of a fixed combination of xanthan gum and chondroitin sulfate preservative free on the ocular surface of patients with dry eye disease during 60 days of intervention. METHODS: A phase III, double-blind, masked, controlled, multicenter, clinical trial of 148 subjects, randomized to either a fixed combination of xanthan gum 0.09 % and chondroitin sulfate 0.1 % (XG/CS) ophthalmic solution (n = 76) or a fixed combination of polyethylene glycol 400 0.4 % and propylene glycol 0.3 % (PEG/PG) (n = 72). Subjects self-dosed four times daily during 60 days. Follow-up was set on days 2, 7, 15, 30 and 60. Assessments of anterior/posterior segment ocular signs were performed. The outcome measures included Schirmer test, tear film break-up time and OSDI score. Security variables included intraocular pressure, lisamine green and fluorescein ocular surface stains. RESULTS: The primary efficacy endpoints were similar between groups at baseline. After intervention time Schirmer test increased in both groups compared to baseline, XG/CS (6.4 ± 2.2 vs 11.0 ± 6.6; p = 0.002) and PEG/PG (6.5 ± 2.5 vs 10.5 ± 5.6; p = 0.019) respectively. Similar results were reported in the tear film break-up time in XG/CS (5.5 ± 2.1 vs 7.4 ± 2.9; p = 0.027) and PEG/PG (5.2 ± 2.0 vs 7.4 ± 2.7; p = 0.046) respectively. The OSDI score decreased to normal values in both groups, XG/CS (19.3 ± 7.4 vs 7.3 ± 5.9; p = 0.001) and PEG/PG (19.3 ± 7.5 vs 7.9 ± 8.2; p = 0.001) respectively. There was no significant difference between treatments for any parameter. Moreover, both groups decreased the presence of burning sensation, tearing, foreign body sensation, conjunctival hyperemia and photophobia. The adverse events were not related to the interventions. CONCLUSIONS: Xanthan gum/chondroitin sulfate preservative free showed similar clinical efficacy, evaluated with OSDI score, TBUT and Schirmer test compared to polyethylene glycol/propylene glycol in the treatment of dry eye disease. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01657253 . Date of registration May 19, 2014.

Triancinolona intra-vítrea e clorpromazina retrobulbar como alternativas ao manejo do olho cego doloroso / Intravietrea trianciclone and retotubulbar chlorpromazine as alternative to blind paintful eye manegement

RESUMO Objetivo: O objetivo desde estudo foi avaliar a efetividade da triancinolona intra-vítrea e da clorpromazina retrobulbar como alternativas no manejo da dor ocular em olhos cegos. Métodos: Este foi um estudo prospectivo intervencionista não-randomizado de pacientes com olho cego doloroso não responsivo ao tratamento tópico e sem indicação de evisceração atendidos no Serviço de Oftalmologia do Hospital Governador Celso Ramos no ano de 2010. Após exame oftalmológico e ultrassonografia ocular modo B, os pacientes foram divididos em dois grupos. Pacientes do Grupo 1 possuíam glaucoma intratável e receberam injeção retrobulbar de clorpromazina 2,5ml, e pacientes do Grupo 2 possuíam olhos phthisicos com componente inflamatório e receberam injeção intra-vítrea de triancinolona 0,3ml. Foram realizadas avaliações com 1, 3 e 6 meses após o procedimento e a dor quantificada de forma subjetiva em uma escala de 0 a 10 (sem dor e com o máximo de dor, respectivamente). Resultados: Foram incluídos 38 olhos, sendo 15 no Grupo 1 e 21 no Grupo 2. Houve predomínio do sexo masculino e idade média de 54 anos. A causa mais prevalente de olho cego doloroso foi o glaucoma neovascular. Tanto a injeção de clorpromazina retrobulbar quanto a de triancinolona intra-vítrea mostraram-se eficazes no controle da dor ocular em olhos cegos no período do estudo (p<0,001). Ocorreu uma redução de 77,1% no uso de colírios (p<0,01) após a aplicação das medicações. Conclusão: Tanto a injeção de clorpromazina retrobulbar quanto a de triancinolona intra-vítrea mostraram resultados significativos no controle da dor ocular em olhos cegos, além de uma redução no uso de colírios. A clorpromazina é um medicamento de baixo custo, com melhor perfil de efeitos adversos e mostrou resultados discretamente melhores relação à triancinolona. Possíveis viéses identificados no estudo são o de tempo e seleção.

ABSTRACT Objective: The objective of this study was to evaluate the efficacy of intravitreal triamcinolone and retrobulbar chlorpromazine as alternatives in the management of ocular pain in blind eyes. Methods: This was a non-randomized interventional prospective study of patients with painful blind eye unresponsive to topical treatment and without indication of evisceration treated at the Hospital Governador Celso Ramos Ophthalmology Service in 2010. After ocular examination and ocular B mode ultrasound, patients were divided into two groups. Group 1 patients had intractable glaucoma and received retrobulbar injection of chlorpromazine 2.5ml, and Group 2 patients had phthisics eyes with inflammatory component and received intravitreal triamcinolone injection 0.3ml. Evaluations were performed at 1, 3 and 6 months after the procedure and quantified pain subjectively on a scale from 0 to 10 (no pain and maximum pain, respectively). Results: 38 eyes were included, 15 in Group 1 and 21 in Group 2. There was a predominance of males with a mean age of 54 years. The most prevalent cause of painful blind eye was the neovascular glaucoma. Any retrobulbar injection of chlorpromazine as the intravitreal triamcinolone shown to be effective in the control of ocular pain in the eye blind study period (p <0.001). There was a 77.1% reduction in eye drops (p <0.01) after application of medication. Conclusion: Both the retrobulbar injection chlorpromazine as the intravitreal triamcinolone showed significant results in the control of ocular pain in blind eyes, and a reduction in the use of eye drops. Chlorpromazine is a low cost product, with a better adverse effect profile and showed slightly better results compared to triamcinolone. Potential bias identified in the study are the time and selection.

Treatment of patients with painful blind eye using stellate ganglion block / Tratamento de pacientes portadores de olho cego doloroso por meio de bloqueio de gânglio estrelado

BACKGROUND AND OBJECTIVES: management of pain in painful blind eyes is still a challenge. Corticosteroids and hypotensive agents, as well as evisceration and enucleation, are some of the strategies employed so far that are not always effective and, depending on the strategy, cause a deep emotional shock to the patient. Given these issues, the aim of this case report is to demonstrate a new and viable option for the management of such pain by treating the painful blind eye with the stellate ganglion block technique, a procedure that has never been described in the literature for this purpose. CASE REPORT: six patients with painful blind eye, all caused by glaucoma, were treated; in these patients, VAS (visual analogue scale for pain assessment, in which 0 is the absence of pain and 10 is the worst pain ever experienced) ranged from 7 to 10. We opted for weekly sessions of stellate ganglion block with 4 mL of bupivacaine (0.5%) without vasoconstrictor and clonidine 1 mcg/kg. Four patients had excellent results at VAS, ranging between 0 and 3, and two remained asymptomatic (VAS = 0), without the need for additional medication. The other two used gabapentin 300 mg every 12 h. CONCLUSION: currently, there are several therapeutic options for the treatment of painful blind eye, among which stand out the retrobulbar blocks with chlorpromazine, alcohol and phenol. However, an effective strategy with low rate of serious complications, which is non-mutilating and improves the quality of life of the patient, is essential. Then, stellate ganglion block arises as a demonstrably viable and promising option to meet this demand.

JUSTIFICATIVA E OBJETIVOS: o manejo da dor em olhos cegos dolorosos ainda é um desafio. Corticosteroides e hipotensores, bem como evisceração e enucleação, são algumas das estratégias até então empregadas, nem sempre eficazes e que, a depender da estratégia, causam um profundo abalo emocional no paciente. Dadas essas questões, o objetivo deste relato de caso é demonstrar uma nova e viável opção para o manejo desse tipo de dor por meio do tratamento do olho cego doloroso com bloqueios de gânglio cervicotorácico, técnica nunca descrita na literatura para esse fim. RELATO DE CASO: foram tratados seis pacientes portadores de olho cego doloroso, todos por glaucoma, nos quais a EVA (escala visual analógica para avaliação da dor em que 0 é ausência de dor e 10 é a maior dor já experimentada) variava de 7 a 10. Optou-se por sessões semanais de bloqueio de gânglio cervicotorácico com 4 mL de bupivacaína (0,5%) sem vasoconstritor e clonidina 1 mcg/Kg. Quatro pacientes apresentaram excelente resultado EVA, com variação entre 0 e 3, e dois permaneceram assintomáticos (EVA = 0), sem necessidade de medicação suplementar. Os outros dois usaram gabapentina 300 mg de 12 em 12 horas. CONCLUSÃO: atualmente, várias são as opções terapêuticas para o tratamento do olho cego doloroso, entre as quais se destacam os bloqueios retrobulbares com clorpromazina, álcool e fenol. No entanto, uma estratégia eficaz, com pequeno índice de complicações graves, não mutilante e que melhore a qualidade de vida do paciente é imprescindível. O bloqueio do gânglio cervicotorácico surge, pois, como uma opção comprovadamente viável e promissora para atender a essa demanda.

Analgesia preemptiva com dipirona versus ibuprofeno na fotocoagulação a laser da retina / Preemptive analgesia of metamizole versus ibuprofen in retinal laser photocoagulation

RESUMO Objetivo: Comparar a efetividade da dipirona versus o ibuprofeno para a redução da dor na fotocoagulação da retina (FR). Método: Foi realizado um estudo controlado, duplo cego e randomizado englobando trinta e quatro pacientes com retinopatia diabética separados em dois grupos. Grupo A recebeu 1000mg de dipirona e o grupo B recebeu 600mg de ibuprofeno. A dor foi avaliada pela escala visual analógica. Resultado: A média do escore da dor nos grupos A e B foi de 5,2 ± 2.6 e 4,5 ± 1,4, respectivamente. Não houve diferença estatística entre os grupos (p=0,34). O mesmo foi observado quanto à analise entre dor leve, moderada e grave (p=0,09). Os grupos foram semelhantes quanto à idade e sexo. Conclusão: Os medicamentos foram equivalentes ou equipotentes em reduzir a dor ocular durante a fotocoagulação a laser da retina.

ABSTRACT Objective: To compare the effectiveness of metamizole versus ibuprofen for the reduction of pain in retinal photocoagulation (RP). Method: A double-masked randomized controlled study was performed. Thirty-four patients with diabetic retinopathy were enrolled. The patients were randomized into two groups. Group A received oral 1000 mg metamizole. Group B received an oral intake of 600 mg ibuprofen. Pain during RP was assessed using a visual analog scale. Results: The mean pain scores for groups A and B were 5.2±2.6 and 4.5±1.4 (p=0.34). There were no significant differences in the mean pain scores between the two groups. The same is observed when analyzing by low, medium and high pain (p=0.09). The groups were similar in age and gender. Conclusion: Both drugs were equivalents or equipotent in reduce ocular pain during retinal photocoagulation.

Treatment of patients with painful blind eye using stellate ganglion block.

BACKGROUND AND OBJECTIVES: management of pain in painful blind eyes is still a challenge. Corticosteroids and hypotensive agents, as well as evisceration and enucleation, are some of the strategies employed so far that are not always effective and, depending on the strategy, cause a deep emotional shock to the patient. Given these issues, the aim of this case report is to demonstrate a new and viable option for the management of such pain by treating the painful blind eye with the stellate ganglion block technique, a procedure that has never been described in the literature for this purpose. CASE REPORT: six patients with painful blind eye, all caused by glaucoma, were treated; in these patients, VAS (visual analogue scale for pain assessment, in which 0 is the absence of pain and 10 is the worst pain ever experienced) ranged from 7 to 10. We opted for weekly sessions of stellate ganglion block with 4 mL of bupivacaine (0.5%) without vasoconstrictor and clonidine 1 mcg/kg. Four patients had excellent results at VAS, ranging between 0 and 3, and two remained asymptomatic (VAS=0), without the need for additional medication. The other two used gabapentin 300 mg every 12h. CONCLUSION: currently, there are several therapeutic options for the treatment of painful blind eye, among which stand out the retrobulbar blocks with chlorpromazine, alcohol and phenol. However, an effective strategy with low rate of serious complications, which is non-mutilating and improves the quality of life of the patient, is essential. Then, stellate ganglion block arises as a demonstrably viable and promising option to meet this demand.

Improved Evaluation of Postoperative Pain After Photorefractive Keratectomy.

PURPOSE: Postoperative pain remains an important limiting factor to the selection of photorefractive keratectomy (PRK). There is a consensus in neurology pain research that pain should be evaluated as a multidimensional concept, which differs from current practice in ophthalmology. The purpose of this paper was to validate the use of multidimensional questionnaires, such as the Brief Pain Inventory (BPI) and the McGill Pain Questionnaire (MPQ), to provide an improved analysis of pain after PRK and to better describe its temporal profile. METHODS: This prospective study included 43 eyes of 43 myopic patients who underwent unilateral PRK. After surgery, usual pain treatment was administered. All of the participants responded to the Visual Analogue Scale (VAS), the BPI and the MPQ 1, 24, 48, 72, and 96 hours after surgery. The internal consistency was evaluated, different postoperative periods were compared, and convergent validity was assessed using correlation testing. RESULTS: The Cronbach alpha test showed high internal consistency for each of the questionnaire subscales. Patients reported higher postoperative pain values at the first measurement of the VAS (4.93 ± 2.38), MPQ-pain rating index (26.95 ± 10.58), BPI-pain severity index (14.53 ± 7.36), and BPI-pain interference index (22.30 ± 15.13). Almost all of the scales and subscales showed a statistically significant direct correlation with the VAS at all of the evaluation periods. CONCLUSIONS: This study validated the utility of multidimensional questionnaires to expand the assessment of the PRK postoperative pain profile, including intensity and other qualitative aspects.

Analgesic effect of etoricoxib (Arcoxia®) 120 mg during retinal laser photocoagulation.

PURPOSE: Panphotocoagulation reduces the risk of vision loss in proliferative diabetic retinopathy. However, not many patients tolerate this treatment well due to pain. Therefore, we evaluated the analgesic effect of etoricoxib during photocoagulation in patients with proliferative diabetic retinopathy. METHODS: A prospective, randomized, double-blind study was conducted on 44 consecutive patients eligible for panphotocoagulation due to proliferative diabetic retinopathy. During the first panphotocoagulation session, both groups were treated without medication. During the following session, the control group received a placebo pill while the other group received etoricoxib 120 mg. Both groups took the medicines 1 hour before the treatment. After each session, the patients quantified the level of pain on a subjective visual scale. RESULTS: A total of 52 patients were selected for the study and the data of 44 patients were analyzed. In the control group, the average level of pain in the first session was 7.68 (standard deviation 1.70), dropping to an average of 7.32 (standard deviation 1.39) after ingestion of placebo. Therefore, there was no statistical difference (p = 0.1187). In contrast, the average level of pain without the drug in the group taking etoricoxib 120 mg was 7.95 (standard deviation 1.46) vs 5.18 (standard deviation 1.65) with the drug, a significant statistical difference (p<0.001). CONCLUSIONS: Etoricoxib 120 mg reduces pain and can be used before panphotocoagulation. Data show that the medication is more effective against pain during photocoagulation than placebo.

Gabapentin for postoperative pain after photorefractive keratectomy: a prospective, randomized, double-blind, placebo-controlled trial.

PURPOSE: To determine whether treatment with oral gabapentin reduces postoperative pain after photorefractive keratectomy (PRK). METHODS: This prospective, randomized, double-blind, placebo-controlled study comprised 40 patients scheduled for bilateral PRK. Exclusion criteria were previous refractive surgery; diseases that could affect epithelial healing; use of antihistamines, nonsteroidal anti-inflammatory drugs, or steroids; and use of mitomycin C during PRK. Patients were divided into two groups: 20 patients received gabapentin capsules (300 mg) and 20 patients received identical placebo capsules. Visual acuity, slit-lamp examination, and a 12-question, 10-point visual numerical scale questionnaire were evaluated at each postoperative follow-up. Main outcome measures were the severity of pain at each follow-up and during the previous 24 hours. Secondary outcome measures were maximum and minimum severity of pain, healing time, uncorrected distance visual acuity, and the rating of other symptoms and potential side effects. RESULTS: The gabapentin group had less pain during the first 72 hours (P=.024 to .001). A significant difference in favor of gabapentin was found for the first 48 hours regarding minimum pain severity (P=.005 and .01 for 24 and 48 hours, respectively) and for the first 72 hours for maximum pain severity (P=.014, .007, and .001 for 24, 48, and 72 hours, respectively). No significant differences were observed for side effects, symptoms, or healing time except discomfort in favor of gabapentin during the first 24 hours (P=.043). CONCLUSIONS: Gabapentin significantly reduced postoperative pain after PRK compared to placebo, with no increase in reported side effects.