Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain After Total Knee Arthroplasty
Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain on the First Post-operative Day After Total Knee Arthroplasty
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Patients will be included on the first day after TKA surgery and randomized in two groups. Each group will receive 2 ACB with a 1 hour interval, one ACB with an active drug, Ropivacaine, and another ACB with a placebo drug, Saline.
At T0, arm ACB_active/placebo will receive the active ACB with Ropivacaine followed by the placebo ACB at T60 (60 minutes after T0).
At T0, arm ACB_placebo/active will receive the placebo ACB with Saline followed by the active ACB with Ropivacaine at T60 (60 minutes after T0).
Outcome measurements will be made at T60, 1 hour after the first ACB, and the difference in outcome between the groups will be compared.
Baseline values will be measured prior to the first ACB. Final measurements at T120 (120 minutes after the initial ACB), will determine if the differences between the groups are eliminated, since both groups then have received an active ACB.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Hellerup, Dinamarca, 2900
- Gentofte 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:
- Patients who have had a Total Knee Arthroplasty surgery within 2 days (1.postoperative day on inclusion)
- Written informed consent.
- ASA 1-3
Exclusion Criteria:
- Non-cooperative patients
- Patients who have already had a peripheral or central block post surgery.
- Patients who are not able to perform a TUG test pre surgery.
- Patients who do not understand or speak Danish.
- Patient who are allergic to the drugs used in this research.
- Patients with alcohol- or drug abuse - determined by investigator.
- Patients with peripheral sensory neuropathy in their lower extremities.
- Pregnant patients.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: ACB_active/placebo
Patients will receive the first ACB with a active drug, 30 ml bolus Ropivacaine 7,5 mg/ml at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60 (60 minutes after T0), patients will receive their second ACB with the placebo drug, 30 ml bolus Saline and outcome measures performed again at T120(120 minutes after T0). The measurements for baseline and outcome will be made in following order: VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test |
Outros nomes:
Outros nomes:
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Comparador de Placebo: ACB_placebo/active
Patients will receive the first ACB with placebo, 30 ml isotonic saline at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60(60 minutes after T0), patients will receive their second ACB with the ropivacaine 7,5 mg/ml 30 ml and outcome measures performed again at T120(120 minutes after T0). The measurements for baseline and outcome will be made in following order: VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test |
Outros nomes:
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Difference between groups in muscle strength of the quadriceps femoris muscle.
Prazo: 60 minutes after first ACB (T60)
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Muscle strength is assessed as maximum voluntary isometric contraction (MVIC) using a hand-held dynamometer.3
consecutive measurements will be made and the average used.
Results for each group will be presented as percentage of baseline values.
The primary outcome is the difference in MVIC between the groups.
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60 minutes after first ACB (T60)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Difference between groups in muscle strength of the quadriceps femoris muscle.
Prazo: 120 minutes after initial ACB (T120)
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Same as primary outcome
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120 minutes after initial ACB (T120)
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VAS pain scores at rest
Prazo: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)
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Pain at rest (VAS 0-100 mm) one hour after the first and second ACB. Results will be compared between the two groups. VAS pain scores at rest will be inquired before any other outcome measurements. |
60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)
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VAS pain score during TUG test.
Prazo: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
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Highest VAS (0-100 mm) pain score during TUG test will be inquired for each TUG test.
Results will be compared between the two groups.
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60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
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Timed Up and Go(TUG) test
Prazo: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
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Time (seconds) to complete a TUG test measured one hour after the first and second ACB.
Results will be compared between the two groups.
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60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
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VAS pain scores during 45 degrees active flexion of the knee
Prazo: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
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Specification of pain (VAS 0-100 mm) during 45 degrees active flexion of the knee one hour after first and second ACB.
Results will be compared between the two groups.
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60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
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Sub-group analysis of muscle strength and mobility acconding to baseline VAS during active flexion of the knee prior to the first block
Prazo: 60 minutes after first ACB (T60)
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According to their specified VAS (0-100 mm) pain score during active flexion of the knee prior to the first block, patients will be divided into two groups.
Group 1 VAS 0-59 mm and group 2 with VAS 60-100 mm.
Results within the two groups will be compared: e.g is there a difference in MVIC in the subgroup of patients scoring VAS 0-59 during active knee flexion at baseline?
and is this difference larger in the subgroup of patients scoring VAS 60-100?
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60 minutes after first ACB (T60)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ulrik Grevstad, MD, Gentofte Hospital
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
- 2014-002245-21
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