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Determining the Minimum Effective Volume of Local Anesthetic for Ultrasound-guided Axillary Brachial Plexus Block

16 de novembro de 2012 atualizado por: Leonardo Henrique Cunha Ferraro, Federal University of São Paulo
This is a study to calculate the minimum effective volume of bupivacaine 0,5% with epinephrine for successful axillary brachial plexus block for hand surgery in 50% of the patients (MEV50).

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

Study Design All patients had their demographic data recorded upon inclusion in the study. Routine preoperative monitoring was subsequently performed using ECG, non-invasive blood pressure measurements and pulse oximetry. Intravenous access was established and maintained with a crystalloid infusion.

The axillary approach using ultrasound (M-Turbo ® System with HFL 38x linear transducer 13-6 MHz, SonoSite, Bothell, WA, USA) and peripheral nerve stimulation (Stimuplex ® DIG RC, B. Braun, Melsung, Germany) guidance was performed to obtain brachial plexus block with the patient lying in the supine position. The needle used was a 22G x 50 mm (AEQ2250, BMD Group, Venezia, Italy). The puncture site was infiltrated with lidocaine 1% after asepsis and antisepsis skin treatment with chlorhexidine. After that, the ulnar, radial, median and musculocutaneous nerves were visualized by ultrasound (Figure 1) and had their identity confirmed by nerve stimulation. An initial dose of 5 mL of bupivacaine 0.5% with adrenaline (1:200,000) was injected in the proximity of each nerve. If severe pain at the injection was referred or, if nerve diameter changed during injection, injection was immediately interrupted, patient was removed form study and followed postoperatively for possible intraneural injection. The needle was repositioned during injection and perineural injected was ensured by ultrasound.

The efficacy of the block was assessed by an assessor blinded to injected volume. Assessments were conducted every 5 min up to a total of 30 min following the end of the injection of the local anaesthetic. Block assessment was finished either after surgical anaesthesia was achieved or,after 30 min had elapsed.

Success or failure of the block was used to dynamically reduce or increase, respectively, the volume of local anaesthetic that was used for the subsequent patient. When a block was achieved, the subsequent patient received a 0.5 mL reduction in the total volume of local anaesthetic per nerve. Upon failure of the block, the patient received a complementation of nerve blocks at a point distal to the axilla, and the volume of local anaesthetic delivered to the next patient was increased by 0.5 mL. After the block was assessed, the patients were cleared for surgery. During surgery, an infusion of 25-50 mcg.kg-1.min-1 of propofol was used to achieve proper sedation. Also, if during the procedure pain was referred, the block was considered failure and a conversion to general anaesthesia was performed.

After surgery, the patients were admitted to the post-anaesthetic recovery room, where they were continuously monitored using ECG as well as non-invasive blood pressure and pulse oximetry until the requirements for discharge were met. Postoperative analgesia was evaluated in the recovery room using a visual analogue pain scale (VAS) three hours after the block.

Tipo de estudo

Intervencional

Inscrição (Real)

19

Estágio

  • Não aplicável

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

      • São Paulo, Brasil, 04024-002
        • Federal University of São Paulo

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

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • ASA 1 and 2 adult patients scheduled for ambulatorial hand surgery were included

Exclusion Criteria:

  • cognitive impairment,
  • coagulopathy,
  • allergy to bupivacaine,
  • infection at the puncture site,
  • body mass index > 35 kg/m2.

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

  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: Bupivacaine 0,5%
Single arm study
The study method was a step-up/step-down sequence model where the dose for following patients was determined by the outcome of the preceding block. The starting dose of bupivacaine was 5 mL per nerve. In the case of block failure, the dose was increased by 0.5 mL per nerve. Conversely, block success resulted in a reduction in dose by 0.5 mL per nerve. Each of the three nerves was treated as a separate entity. Dose adjustments were made to each nerve individually. The volume dose was increased in 0.5 mL at every 5 consecutive cases regardless of the result of the previous block in order to minimize bias occurence. A blinded assistant assessed sensory and motor blockade at 5-min intervals up to 30 min.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Determining the minimum effective volume of bupivacaine 0,5% with epinephrine For successful axillary brachial plexus block for hand surgery
Prazo: A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 30 minutes.
Assessment of the success of ABPB A motor function score of 2 or less on the modified Bromage scale and also a lack of thermal sensitivity and response to a pinprick in the regions of the median, ulnar, radial and musculocutaneous nerves were considered characteristics of a successful block. Moreover, the surgery should be concluded without any complementary analgesia to confirm the success of the anaesthetic procedure.
A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 30 minutes.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Leonardo HC Ferraro, MD, Federal University of São Paulo

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

1 de dezembro de 2010

Conclusão Primária (Real)

1 de novembro de 2011

Conclusão do estudo (Real)

1 de agosto de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

21 de agosto de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de agosto de 2011

Primeira postagem (Estimativa)

23 de agosto de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

19 de novembro de 2012

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de novembro de 2012

Última verificação

1 de novembro de 2012

Mais Informações

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 .

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