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Selective Trunk Block: A Study to Evaluate Block Dynamics, Effects and Efficacy for Upper Limb Surgery

27 de julho de 2021 atualizado por: Prof Manoj K Karmakar, Chinese University of Hong Kong

Selective Trunk Block: A Prospective Non-Randomized Study to Evaluate Block Dynamics, Effects on Ipsilateral Hemidiaphragmatic (Phrenic Nerve) Function and Efficacy for Upper Extremity Surgery

Brachial plexus block (BPB) is frequently used as the sole anesthetic technique for upper extremity surgery. The choice of technique often depends on the site of surgery because the extent of sensory-motor blockade after a BPB varies with the technique used. The investigator is not aware of any single BPB technique described to date that can consistently produce surgical anesthesia of the whole ipsilateral upper extremity. However, occasionally surgery entails that the whole upper extremity, i.e. from the shoulder to the elbow, or even the forearm, wrist or hands. This clinical challenge has been addressed previously using a combination of BPB techniques. The investigator has recently demonstrated that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks, using ultrasound imaging. Since majority of the innervation of the upper extremity, i.e. shoulder, arm, elbow, forearm, wrist and hand, originates from the three trunks of the brachial plexus, the investigator hypothesized that selectively blocking upper, middle, and inferior trunks of the brachial plexus will produce surgical anesthesia of the whole ipsilateral upper extremity. This study is a continuation of a previously approved study with title "Selective Trunk Brachial Plexus Block: A Prospective Non-Randomized Study of Intervention" [NCT04510259] after the amendment (study title, protocol and increased sample size) was rejected by local IRB and suggested to submit as a new protocol. The aim of this study is to assess a novel brachial plexus block technique, the selective trunk block (SeTB), and provide preliminary clinical evidence of its effectiveness in producing surgical anesthesia of the whole ipsilateral upper extremity.

Visão geral do estudo

Status

Concluído

Descrição detalhada

Brachial plexus block (BPB) is frequently used as the sole anesthetic technique for upper extremity surgery. The choice of technique often depends on the site of surgery because the extent of sensory-motor blockade after a BPB varies with the technique used. The investigator is not aware of any single BPB technique described to date that can consistently produce surgical anesthesia of the whole ipsilateral upper extremity (shoulder to fingers). However, occasionally surgery entails that the whole upper extremity is anesthetized, i.e. from the shoulder to the elbow, or even the forearm, wrist or hands. This clinical challenge has been addressed previously using a combination of BPB (hybrid) techniques. The investigator has recently demonstrated that it is feasible to accurately identify majority of the individual components of the brachial plexus above the clavicle, including the three trunks, using ultrasound imaging. Since majority of the innervation of the upper extremity, i.e. shoulder, arm, elbow, forearm, wrist and hand, originates from or pass through the three trunks of the brachial plexus, the investigator hypothesized that selectively blocking the upper, middle, and inferior trunks of the brachial plexus will produce surgical anesthesia of the whole ipsilateral upper extremity, except for the area innervated by the intercostobrachial nerve (T2 - medial aspect of the upper arm). The investigator refers this novel technique as "selective trunk block" (SeTB). Currently there are no published data on block dynamics, safety or efficacy of SeTB. In addition, there may be a potential advantage that phrenic nerve can be spared, so this blockade will not affect the respiratory function as it is common to see phrenic nerve palsy after interscalene BPB (100%) and supraclavicular BPB (50-67%). This study is a continuation of a previously approved study with title "Selective Trunk Brachial Plexus Block: A Prospective Non-Randomized Study of Intervention" [NCT04510259] after the amendment (study title, protocol and increased sample size) was rejected by local IRB and suggested to submit as a new protocol. The aim of this study is to assess a novel brachial plexus block technique, the selective trunk block (SeTB), and provide preliminary clinical evidence of its effectiveness in producing surgical anesthesia of the whole ipsilateral upper extremity.

Tipo de estudo

Intervencional

Inscrição (Real)

30

Estágio

  • Não aplicável

Contactos e Locais

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Locais de estudo

    • Kowloon
      • Shatin, Kowloon, Hong Kong
        • Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

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 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • elective upper extremity surgery
  • emergency upper extremity surgery

Exclusion Criteria:

  • Patient refusal
  • pregnancy
  • local skin site infection
  • allergy to local anesthetics
  • bleeding tendency
  • pre-existing neurological deficit
  • pre-existing neuromuscular disease.

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

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Selective Brachial plexus block
Selective brachial plexus block will be done under ultrasound guidance to patients scheduled for upper extremity surgeries. Local anesthetic agents (a mixture of 2% lidocaine with 1:200,000 epinephrine and 0.5% levobupivacaine in a total of 25ml) will be injected at the superior, middle, and inferior trunks of the brachial plexus in order to anesthetize the whole upper limb.
It is one type of peripheral nerve blocks for upper extremity surgery. In this study, the block will be done under the ultrasound guidance and the local anesthetic agent (a mixture of 2% Xylocaine with 1:200,000 adrenaline and 0.5% Chirocaine in a total of 25ml) will be injected at the trunks of the brachial plexus in order to produce the surgical anesthesia of the whole upper extremity of the patients scheduled for upper limb surgeries.
Outros nomes:
  • Medicamento

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Changes of sensory block of the upper extremity
Prazo: within 45 minutes after the block at 5 minutes interval
Sensation to coldness (ice) will be tested at the median (lateral three and half digits on the palmar side), radial (dorsal side of hand), ulnar (medial one and a half digits), musculocutaneous (lateral side of the forearm) and axillary (skin over the lower deltoid) and graded using a verbal rating scale (VRS:0-100, 100=normal sensation, 0=no sensation). Onset of sensory block for each nerve will be defined as the time that it took to achieve a sensory block score of =<30.
within 45 minutes after the block at 5 minutes interval
Changes of motor block of the upper extremity
Prazo: within 45 minutes after the block at 5 minutes interval
Motor blockade will be graded using a 3-points scale revising from previous study: 2=no block, 1=paresis and 0=paralysis. Motor blockade of each individual nerve in the anesthetized upper extremity will be evaluated by testing for opposition of thumb with the index finger (median nerve), wrist extension (radial nerve), thumb opposition with little finger (ulnar nerve), elbow flexion (musculocutaneous nerve) abduction of shoulder (axillary nerve), and external rotation of the arm with elbow flexed and simulate emptying a can motion and test for power against resistance (Suprascapular nerve). The onset of motor block for each nerve will be defined as motor grading at each nerve =<1. Complete block will be defined as a sensory and motor block score of '0' in all nerves functions.
within 45 minutes after the block at 5 minutes interval
Readiness for surgery
Prazo: within 45 minutes after the block at 5 minutes interval
overall sensory scores =<30 (VRS: 0-100, 100=normal sensation, 0=no sensation) and motor score =<1 (3-points scale, 2=no block, 1=paresis, 0=paralysis) in all the nerves tested.
within 45 minutes after the block at 5 minutes interval

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Changes of the Diaphragmatic function
Prazo: Baseline (before brachial plexus block) and at 30 minutes after block
Excursion of the right hemidiaphragm will be measured by ultrasound machine in supine position via the anterior subcostal route. The movement of the diaphragm will be measured in centimetres. The range of diaphragmatic excursion will be recorded from the resting expiratory position to deep inspiration (sigh test) as will be range of diaphragmatic movement from resting expiratory position when quickly inspiring through the nose (sniff test). The decrease in diaphragmatic excursion will be calculated as the difference (in percentage) in diaphragmatic excursion measured before and 30 minutes after SeTB. Reduction in diaphragmatic excursion of more than 75% of baseline, or no movement, or paradoxical movement will be considered as complete paresis. Reduction in diaphragmatic excursion of between 25% and 75% will be considered as partial paresis and diaphragmatic excursion of less than 25% will be considered as 'no paresis'.
Baseline (before brachial plexus block) and at 30 minutes after block

Colaboradores e Investigadores

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Publicações e links úteis

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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 (Real)

19 de fevereiro de 2021

Conclusão Primária (Real)

27 de julho de 2021

Conclusão do estudo (Real)

27 de julho de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

9 de fevereiro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de fevereiro de 2021

Primeira postagem (Real)

12 de fevereiro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de julho de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de julho de 2021

Última verificação

1 de julho de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • Updated SeTB (CREC.2020.308)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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