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Public trial
 

                                        

                    

                        

                            

                            

                        

                        

                            

                                
RBR-5jszxw Analysis of the effective dose for analgesia in knee surgery with saphenous nerve block by ultrasound


                                Date of registration:
                                
                                    04/30/2019                                    (mm/dd/yyyy)
                                
                                

                                Last approval date :
                                
                                    04/30/2019                                    (mm/dd/yyyy)
                                
                                
Study type:


                                
Interventional


                                
 


                                
 


                                
Scientific title:


                                

                                                                        

                                        
en

                                        
Evaluation of the Minimum Effective Concentration (CEM) analgesic of ropivacaine in ultrasound guided safeno block for knee arthroscopy Randomized, double blind study

                                        

                                        
pt-br

                                        
Avaliação da Concentração Eficaz Mínima (CEM) analgésica de ropivacaína em bloqueio safeno guiado por ultrassom para artroscopia de joelho Estudo randomizado, duplo cego

                                        
                                


                                
 



                                
Trial identification

                                
    
                                    
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                                        UTN code: 
                                        U1111-1223-6103
                                    
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    Public title:
    
                                        
    
                                                                                        
    
                                                    
    en
    
                                                    
    Analysis of the effective dose for analgesia in knee surgery with saphenous nerve block by ultrasound
    
                                                
    
                                                    
    pt-br
    
                                                    
    Análise da dose efetiva para analgesia em cirurgia de joelho com bloqueio do nervo safeno por ultrassom
    
                                                
                                            
    
                                    
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    Scientific acronym:
    
                                        
    
                                                                                                                                
    
                                    
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    Public acronym:
    
                                        
    
                                                                                                                                
    
                                    
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                                        Secondaries identifiers:
                                                                                                                            
      
                                                
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                                                    65396017.3.1001.5505 CAAE
      
                                                    Issuing authority:
                                                    Plataforma Brasil
                                                
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                                                    2.035.097
      
                                                    Issuing authority:
                                                    Comitê de Ética em Pesquisa da UNIFESP - Hospital São Paulo
                                                
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Sponsors

                                
    
                                    
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                                        Primary sponsor:
                                        Universidade Federal de São Paulo
                                    
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                                        Secondary sponsor:
                                                                                                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Universidade Federal de São Paulo
                                                
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                                                    Institution:
                                                    Hospital São Domingos
                                                
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                                        Supporting source:
                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Universidade Federal de São Paulo
                                                
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                                                    Institution:
                                                    Hospital São Domingos
                                                
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Health conditions

                                
    
                                    
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    Health conditions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Individuals with knee meniscopathy
    
                                                
    
                                                
    pt-br
    
                                                
    Indivíduos com lesão de menisco de joelho
    
                                                
                                            
    
                                    
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    General descriptors for health conditions:
    
                                                                                
    
                                                
    en
    
                                                
    
                                                    C05
                                                    Musculoskeletal diseases
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    C05
                                                    Doenças musculoesqueléticas
                                                
    
                                                
    
                                                
    es
    
                                                
    
                                                    C05
                                                    Enfermedades musculoesqueléticas
                                                
    
                                                
    
                                                
    en
    
                                                
    
                                                    M00-M99
                                                    XIII - Diseases of the musculoskeletal system and connective tissue
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    M00-M99
                                                    XIII - Doenças do sistema osteomuscular e do tecido conjuntivo
                                                
    
                                                
                                            
     
    
                                    
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    Specific descriptors:
    
                                                                                
     
    
                                    
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Interventions

                                
    








                                    
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    Interventions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Blockade of the saphenous nerve will be performed with injection of local anesthetic ropicaina guided by ultrasound. The dose will be based on the up and down method in which the previous patient is the next patient's control. Accepted method for procedures to discover the effective dose. For the purpose of the study the first patient will use the 0.5% dose of ropivacaine. This type of study has no patient who uses placebo. This methodology provides a number of 45 participants for the 95% confidence interval.
    
                                                
    
                                                
    pt-br
    
                                                
    Será realizado o bloqueio do nervo safeno com injeção de anestésico local ropicaina guiado por ultrassom. A dose será baseado no metodo up and down na qual o paciente anterior é o controle do próximo paciente. Método aceito para procedimentos que visam descobrir a dose efetiva. Para efeito do estudo o primeiro paciente usará a dose de 0,5% de ropivacaína. Este tipo de estudo não tem paciente que usa placebo. Esta metodologia prevê um número de 45 participantes para o intervalo de 95% de confiança.
    
                                                
                                            
    
                                    
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    Descriptors:
    
                                        
    
                                                    
    en
    
                                                    
    
                                                        E03.155.086.711
                                                        Nerve Block
                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        E03.155.086.711
                                                        Bloqueio Nervoso
                                                    
    
                                                    
    
                                                    
    es
    
                                                    
    
                                                        E03.155.086.711
                                                        Bloqueo Nervioso
                                                    
    
                                                    
    
                                                    
    en
    
                                                    
    
                                                        F44.6
                                                        Dissociative anaesthesia and sensory loss 
                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        F44.6
                                                        Anestesia e perda sensorial dissociativas
                                                    
    
                                                    
    
                                                    
    es
    
                                                    
    
                                                        F44.6
                                                        Anestesia disociativa y pérdida sensorial 
                                                    
    
                                                    
                                            
     
    
                                    
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Recruitment

                                
    
                                    
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                                        Study status:
                                                                                Recruiting
                                    
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                                        Countries
                                        
      
                                            
    • Brazil
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                                        Date first enrollment:
                                        
                                                                                        02/10/2018                                            (mm/dd/yyyy)
                                        

                                    
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                                        Date last enrollment:
                                        
                                            06/10/2019                                            (mm/dd/yyyy)
                                        
                                    
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                                                Target sample size:
                                                Gender:
                                                Minimum age:
                                                Maximum age:
                                            
    
                                            
    
                                                45
                                                -
                                                16 Y
                                                75 Y
                                            
    
                                            
    
                                    
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    Inclusion criteria:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Knee meniscopathy; meniscectomy surgery
    
                                                
    
                                                
    pt-br
    
                                                
    Meniscopatia de joelho; cirurgia de meniscectomia de joelho
    
                                                
                                            
    
                                    
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    Exclusion criteria:
    
                                        
    
                                                                                        
    
                                                
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    Patient refusal; coagulopathy; pregnancy; local infection.
    
                                                
    
                                                
    pt-br
    
                                                
    Recusa do paciente; coagulopatia; gravidez; infecção local.
    
                                                
                                            
    
                                    
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Study type

                                
    
                                    
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    Study design:
    
                                        
    
                                                                                    
    
                                    
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                                                    Expanded access program
                                                    Purpose
                                                    Intervention assignment
                                                    Number of arms
                                                    Masking type
                                                    Allocation
                                                    Study phase
                                                
    
                                                
                                            
                                            
    
                                                
                                                Treatment
                                                Single-group
                                                1
                                                Double-blind
                                                Single-arm-study
                                                N/A
                                            
    
                                                
                                        
    
                                    
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Outcomes

                                
    
                                    
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    Primary outcomes:
    
                                        
    
                                                    
    en
    
                                                    
    
                                                        It is expected to find the lowest effective dose of the local anesthetic ropivacaine in the saphenous blockade guided by ultrasound using the up and down method of Dixon. In this method the previous patient is control of the next patient. Diffused and accepted method for effective dose calculations. Analgesia will be verified by the visual analgesic scale and analgesic consumption in the postoperative period and the motor block will be evaluated by the Bromage scale and the use of the force dynamometer. Thus it is expected to find the minim dose that does not promote motor blockade and that allows the patient to go to hospital on the same day, without pain and without motor block.
                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        Espera-se encontrar a menor dose efetiva do anestésico local ropivacaina no bloqueio safeno guiado por ultrassom atraves do método up and down de Dixon. Neste método o paciente anterior é controle do próximo paciente. Método difundido e aceito para cálculos de dose efetiva. A analgesia será verificada pela escala analgésica visual e consumo de analgésicos no pós operatório e o bloqueio motor sera avaliado pela escala de Bromage e pelo uso do dinamometro de força. Assim espera-se achar a dose minim que não promova bloqueio  motor e que permita que o paciente vá de alta hospitalar no mesmo dia, sem dor e sem bloqueio motor. 
                                                    
    
                                                    
                                            
     
    
                                    
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    Secondary outcomes:
    
                                        
    
                                                
    en
    
                                                
    
                                                    Secondary outcomes are not expected
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    Não espera-se desfechos secundários
                                                
    
                                                
                                            
     
    
                                    
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Contacts

                                
    

                                    
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                                        Public contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Monica  Noleto
                                                
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                                                            Address:
                                                            rua napoleao de barros 610
                                                        
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                                                            City: 
                                                            sao paulo / Brazil
                                                        
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                                                            Zip code:
                                                            04024-002
                                                        
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                                                    Phone:
                                                    551150847551
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    universidade federal de sao paulo
                                                
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                                        Scientific contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Ed Carlos Moura
                                                
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                                                            Address:
                                                            Rua Turiaçu 800 Edifício Horizonte Residence apartamento 800
                                                        
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                                                            City:
                                                            São Luís / Brazil
                                                        
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                                                            Zip code:
                                                            65075810
                                                        
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                                                    Phone:
                                                    +5598984046958
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Universidade Federal de São Paulo
                                                
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                                                    Full name:
                                                    Monica  Noleto
                                                
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                                                            Address:
                                                            rua napoleao de barros 610
                                                        
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                                                            City:
                                                            sao paulo / Brazil
                                                        
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                                                            Zip code:
                                                            04024-002
                                                        
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                                                    Phone:
                                                    551150847551
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    universidade federal de sao paulo
                                                
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                                        Site contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Monica  Noleto
                                                
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                                                            Address:
                                                            rua napoleao de barros 610
                                                        
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                                                            City:
                                                            sao paulo / Brazil
                                                        
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                                                            Zip code:
                                                            04024-002
                                                        
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                                                    Phone:
                                                    551150847551
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    universidade federal de sao paulo
                                                
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                                                    Full name:
                                                    Plinio cunha leal
                                                
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                                                            Address:
                                                            avenida jeronimo de albuquerque 540
                                                        
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                                                            City:
                                                            sao luis / Brazil
                                                        
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                                                            Zip code:
                                                            65060-645
                                                        
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                                                    Phone:
                                                    559832264328
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Hospital São Domingos
                                                
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Additional links:

                                                                
                            

                        

                    

                    
 

                            

        

        
 

        
    




            
    

    

        


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