- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07595471
Proximal Spread in Adductor Canal Block(ACB) (ACB)
12 de maio de 2026 atualizado por: Müge Çakırca, Ankara Etlik City Hospital
The Impact of Injection Level on the Proximal Spread of Local Anesthetic and Clinical Outcomes in Adductor Canal Block
This prospective, randomized clinical study is designed to evaluate the effects of two different injection levels of adductor canal block (ACB) on the proximal spread of local anesthetic and clinical outcomes in patients undergoing total knee arthroplasty.
The study will be conducted at Ankara Etlik City Hospital and will include a total of 68 patients.
All cases are limited to unilateral elective knee replacement surgeries performed under spinal anesthesia.
In this study, the comparison will be based on the application of adductor canal block at two distinct injection levels.
In both groups, blocks will be performed under ultrasound (USG) guidance using the same technical principles and standardized conditions; in the first group, the block will be administered at the level where the vasto-adductor membrane is first visualized, while in the second group, it will be performed at the level where the adductor longus ends.
The type, concentration, and volume of local anesthetic used in both groups will be standardized as 20 mL of 0.25% bupivacaine.
The groups will be compared in terms of the proximal spread of the local anesthetic based on the injection level, the area of spread at the apex of the iliopectineal fossa, the involvement of the femoral nerve, the incidence of postoperative falls, and analgesic consumption.
Visão geral do estudo
Status
Ativo, não recrutando
Descrição detalhada
This prospective, randomized clinical trial is designed to evaluate the effects of two distinct injection levels of ultrasound-guided adductor canal block (ACB) on the proximal spread of local anesthetic and clinical outcomes in patients undergoing total knee arthroplasty (TKA).
The study will be conducted at Ankara Etlik City Hospital with a total of 68 patients.
All cases are limited to unilateral elective knee replacement surgeries performed under spinal anesthesia.
Inclusion and Exclusion Criteria Inclusion criteria are defined as patients aged 18 years and older, with an ASA (American Society of Anesthesiologists) physical status of I-III, scheduled for elective unilateral TKA under spinal anesthesia.
Exclusion criteria include patients scheduled for bilateral knee arthroplasty, known allergy to local anesthetics, chronic pain syndromes or regular opioid use, peripheral neuropathy or neurological diseases affecting femoral nerve function, coagulopathy or use of anticoagulant therapy, infection at the injection site, and patients unable to provide written informed consent.
Randomization and Intervention Patients will be randomized into two groups using the sealed envelope method.
In Group 1, the ACB will be performed under ultrasound (USG) guidance at the level where the vasto-adductor membrane (VAM) is first visualized.
In Group 2, the block will be performed at the level where the adductor longus muscle ends.
All blocks will be administered by experienced anesthesiologists using a standardized dose of 20 mL 0.25% bupivacaine.
Clinicians performing the block will not be involved in the postoperative data collection process.
Procedure and Monitoring All patients will undergo standard monitoring, including electrocardiography (EKG), non-invasive arterial blood pressure, and peripheral oxygen saturation (SpO_2).
Following the administration of spinal anesthesia according to clinical protocols, the ACB will be performed under USG guidance based on the randomization results.
Standard care will be provided throughout the surgical and anesthetic management, and perioperative data will be recorded.
Outcome Measures and Evaluation Following the block, the spread of the local anesthetic will be evaluated in real-time using ultrasound.
The distance between the injection point and the highest proximal point of the anesthetic spread will be measured in centimeters.
Additionally, the spread area of the local anesthetic at the level of the apex of the iliopectineal fossa will be recorded using the planimetric measurement tools of the USG device.
The reach of the local anesthetic to the femoral nerve will also be assessed via USG.
Postoperatively, patients will follow standard clinical monitoring.
Motor block will be evaluated based on the incidence of postoperative falls (yes/no).
Sensory block efficacy will be assessed through total analgesic consumption recorded within the first 24 hours postoperatively.
All collected data will be recorded for statistical analysis and compared based on the injection levels.
Tipo de estudo
Intervencional
Inscrição (Estimado)
68
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
-
-
-
Ankara, Turquia (Türkiye), 06000
- Ankara Etlik City 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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
* Patients aged > 18 years.
- ASA physical status classification I-III.
- Patients scheduled for elective, unilateral total knee arthroplasty (TKA).
- Planned administration of spinal anesthesia.
- Ability to provide written informed consent.
Exclusion Criteria:Scheduled for bilateral knee arthroplasty.
- Known hypersensitivity or allergy to local anesthetics.
- History of chronic pain syndrome or regular opioid consumption.
- Presence of peripheral neuropathy or neurological disorders affecting the femoral nerve.
- Coagulopathy or ongoing anticoagulant therapy.
- Active infection at the site of injection.
- Inability or refusal to provide written informed consent.
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: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Group 1: ACB at the proximal vasto-adductor membrane level (20 mL 0.25% bupivacaine)
Group 1: Patients receiving ultrasound-guided adductor canal block with 20 mL of 0.25% bupivacaine at the level where the vasto-adductor membrane is first visualized.
|
In this study, patients were evaluated using two distinct approaches based on the evolution of anatomical definitions in recent literature: the proximal application, traditionally referred to as the adductor canal block but now more accurately defined as the 'Femoral Triangle Block' in current publications,
|
|
Comparador Ativo: Group 2: Level of the end of the adductor longus
Group 2: Patients receiving ultrasound-guided adductor canal block with 20 mL of 0.25% bupivacaine at the level where the adductor longus muscle ends.
|
In this study, patients were evaluated using two distinct approaches based on the evolution of anatomical definitions in recent literature: the proximal application, traditionally referred to as the adductor canal block but now more accurately defined as the true 'Distal Adductor Canal Block' performed in accordance with contemporary anatomical criteria."
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proximal spread of local anesthetic
Prazo: The first postoperative hour
|
The primary objective of this study is to compare the proximal spread of local anesthetic following ultrasound-guided adductor canal block performed at two distinct injection levels.
In the first group, the injection will be administered at the level where the vastoadductor membrane is first visualized ultrasonographically in the proximal region.
In the second group, the injection will be performed at the level where the adductor magnus and sartorius muscles first intersect.In both patient groups, the area of local anesthetic spread at the apex of the iliopectineal fossa will be measured in $cm^2$ using ultrasonography.
Additionally, the distance between the needle insertion point (injection level) and the apex of the iliopectineal fossa, as well as the distance from the needle insertion point to the most proximal point where the local anesthetic is ultrasonographically visualized, will be recorded in cm.
|
The first postoperative hour
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain Scores (Numeric Rating Scale)
Prazo: post-op hours 6 and 24
|
Evaluation of NRS(Numeric Rating Scale) scores at the 6th and 24th postoperative hours.The Numerical Rating Scale (NRS) is a common subjective clinical tool that requires patients to quantify their pain intensity on a scale ranging from 0 to 10
|
post-op hours 6 and 24
|
|
Assessment of Motor Block
Prazo: Postoperative 24th hours
|
Motor block and falls were evaluated at the 24th hour.Ambulation was assessed within the first 24 hours postoperatively.
Successful ambulation was defined as the ability to walk without falling; patients who failed to ambulate or suffered a fall during the attempt were categorized as 'treatment failure'.
|
Postoperative 24th hours
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
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)
7 de abril de 2026
Conclusão Primária (Estimado)
30 de maio de 2026
Conclusão do estudo (Estimado)
1 de junho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
7 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de maio de 2026
Primeira postagem (Real)
19 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2024-KAEK-40 (Outro identificador: Ankara Etlik City Hospital Clinical Research Ethics Committee)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
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
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 .