Saphenous Nerve Block: Single Shot Versus Continuous Infusion to Supplement a Continuous Sciatic Nerve Block After Major Ankle Surgery
A Randomized Comparison of Single Injection vs. Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block in Postoperative Pain Treatment After Major Ankle Surgery: Clinical Outcome and Cost Analysis
The most useful method to manage pain after major ankle surgery is infusion of local analgesics with a catheter close to the sciatic nerve.
Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified in the sciatic nerve) and the saphenous nerve.
Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve catheter provide a better treatment of pain in comparison with a single injection nerve block. In addition cost-effectiveness of the two methods are compared.
The 50 patients of the trial are randomized in clusters of ten. We intend to do a preliminary analysis of the data from the first 40 patients. However, it is not an interim analysis. Fifty patients will be included independent of the result of the preliminary analysis. The random allocation of the last 10 patients will also be double-blinded.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Major ankle surgery are known to be very painful the first 48 hours after the operation due to surgical oedema. This pain is difficult to control with systemic analgesics. Pain relief with systemic analgesics requires high doses of intravenous opioids and is associated with breakthrough pain and adverse effects of opioids (sedation, nausea, vomiting, obstipation, urinary retention, respiratory depression).
Continuous, peripheral nerve block with catheter technique for two days minimizes the need for systemic analgesics. Today such a continuous sciatic nerve block is part of the standard pain treatment after major ankle surgery on Aarhus University Hospital. Despite accurate placement of the catheter many patients are in great pain because the saphenous nerve remain unaffected. A single injection block relieve the pain but a block with Ropivacaine only last 8-15 hours.
Severe postoperative pain leads to high opioid dosages, cognitive blurring, nausea, vomiting, reduced ambulation, increased surgical stress response and increased morbidity. Pain problems and adverse effects prolongs postoperative observation time and maybe also time to discharge.
The aim of the study establish whether continuous saphenous nerve block is efficient (pain relief or reduced opioid consumption) and justified (cost-effectiveness analysis) compared with single injection block.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Aarhus, Dinamarca, 8000
- Aarhus University Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria: Elective major ankle surgery
- total ankle arthroplasty
- subtalar fusion
- ankle fusion (non arthroscopic)
Exclusion Criteria:
- coagulation abnormalities
- infection in the region of needle insertion
- systemic infection
- preoperative consumption of high dose opioid
- preoperative sciatic or femoral nerve neuropathy
- preoperative sensory deficit in either of the lower extremities
- Charcot-Marie-Tooth disorder
- diabetic neuropathy
- severe peripheral vascular disease
- allergy to local anesthetics
- lack of understanding of Numeric Rank Scale (NRS)
- communication problems
- dementia
- body mass index above 35
- bilateral continuous sciatic nerve block
- lack of consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 0,2% Ropivacaine
Patients randomized to the experimental group receive a continuous infusion of 0,2 % Ropivacaine by elastomeric infusion pump at 5 ml/h in the saphenous catheter after major ankle surgery. Infusion for 48 postoperative hours. All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block. |
0,2% Ropivacaine by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
Outros nomes:
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Comparador de Placebo: Control
Patients randomized to the control group receive a continuous infusion of isoton saline by elastomeric infusion pump at 5 ml/h in their catheter after major ankle surgery. Infusion for 48 postoperative hours. All patients receive a preoperative single shot of Ropivacaine around saphenous and sciatic nerve and a postoperative continuous sciatic nerve block. |
Isoton saline by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Accumulated opioid consumption
Prazo: First 48 hours postoperative
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First 48 hours postoperative
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Success rate for saphenous nerve analgesia
Prazo: Postoperative, first 48 hours
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Pain rated by NRS and opioid consumption
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Postoperative, first 48 hours
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Success rate for clinical analgesia of foot and ankle
Prazo: Postoperative, first 48 hours
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Pain rated by NRS and opioid consumption
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Postoperative, first 48 hours
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Success rate for tibial and peroneal nerve block
Prazo: Postoperative, first 48 hours
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Pain rated by NRS and test of sensation on the toes
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Postoperative, first 48 hours
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Localisation of worst pain
Prazo: Postoperative, first 48 hours
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Postoperative, first 48 hours
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Cost-effectiveness
Prazo: 2 first postoperative days
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2 first postoperative days
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Thomas F Bendtsen, ph.d., MD, Aarhus University Hospital
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2011-0184
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