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Comparison of 90° and 120° Arm Positions in Costoclavicular Block (COSTO-RCT)

6 de junho de 2026 atualizado por: ALGAN TURGUT ÇARSANCAKLI, Ankara Etlik City Hospital

Effect of Arm Abduction Degree ( 90° vs. 120° ) on Block Onset Time and Block Success in Costoclavicular Brachial Plexus Block in Patients Undergoing Hand, Wrist and Forearm Surgery: A Prospective Randomized Controlled Trial

The costoclavicular approach of the infraclavicular brachial plexus block is widely used for upper extremity surgeries due to its reliable anatomy and high success rates. Patient positioning, particularly the degree of arm abduction, may influence the spread of local anesthetic and the characteristics of the block. However, the optimal arm abduction angle during this procedure remains unclear.

This prospective randomized controlled trial aims to investigate the effect of two different arm abduction angles (90° and 120°) on block onset time and block success in patients undergoing hand, wrist, and forearm surgery under ultrasound-guided costoclavicular brachial plexus block.

Patients will be randomly assigned to one of two groups according to the degree of arm abduction. The primary outcome is block onset time. Secondary outcomes include block success, sensory and motor block characteristics, perfusion index changes, hemodynamic parameters, readiness for surgery at 15 and 20 minutes, block performance time, need for additional anesthesia, postoperative neurological evaluation at 4 and 24 hours, complications, and patient satisfaction.

The findings of this study are expected to provide evidence on optimal patient positioning to improve the effectiveness and reliability of ultrasound-guided costoclavicular brachial plexus block.

Visão geral do estudo

Descrição detalhada

The costoclavicular approach is a recently described infraclavicular technique for brachial plexus block that provides reliable anesthesia for upper extremity surgeries. Due to the compact arrangement of the cords in the costoclavicular space, this technique has gained popularity for its high success rates and consistent anatomy. However, procedural factors such as patient positioning may influence the distribution of local anesthetic and the effectiveness of the block.

Arm abduction is known to alter the anatomical relationships within the infraclavicular region, potentially affecting needle visualization, spread of local anesthetic, and block characteristics. Despite its clinical relevance, there is limited evidence regarding the optimal degree of arm abduction during ultrasound-guided costoclavicular brachial plexus block.

This prospective randomized controlled study aims to compare two different arm abduction angles 90° and 120° in patients undergoing elective hand, wrist, and forearm surgery. After obtaining written informed consent, eligible patients will be randomly assigned into two groups according to the degree of arm abduction.

All procedures will be performed under ultrasound guidance using a standardized technique. The local anesthetic will be administered in the costoclavicular space, and block characteristics will be assessed systematically. The primary outcome is block onset time, defined as the time from completion of local anesthetic injection to the achievement of adequate sensory block for surgery.

Secondary outcomes include block success, sensory and motor block scores, perfusion index measurements, hemodynamic parameters, readiness for surgery at 15 and 20 minutes, block performance time, need for additional anesthesia or conversion to general anesthesia, early complications, postoperative neurological evaluation at 4 and 24 hours, and patient satisfaction assessed using a Likert scale.

The results of this study are expected to provide valuable evidence regarding optimal patient positioning and contribute to improving the clinical effectiveness and reliability of ultrasound-guided costoclavicular brachial plexus block.

Tipo de estudo

Intervencional

Inscrição (Estimado)

106

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.

Contato de estudo

  • Nome: Algan TURGUT ÇARSANCAKLI, M.D.
  • Número de telefone: +90 532 486 52 69
  • E-mail: alganturgut@gmail.com

Estude backup de contato

  • Nome: Reyhan POLAT, Professor
  • Número de telefone: +90 532 673 43 10
  • E-mail: reyhanp9@gmail.com

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 between 18 and 80 years.
  • Patients scheduled for elective upper extremity surgery (hand, wrist, forearm).
  • Patients classified as ASA I-III.
  • Patients who provide informed consent after being informed about the study.

Exclusion Criteria:

  • History of previous surgery, scar tissue, tumor, or trauma that may alter brachial plexus anatomy.
  • Presence of infection, hematoma, severe edema, burn, or open wound at the block application site.
  • Known allergy to local anesthetics or other medications used in the study.
  • Coagulopathy, use of anticoagulants, or platelet count < 100,000/mm³.
  • History of peripheral neuropathy, neurological deficit, cervical radiculopathy, or CRPS.
  • Pregnancy or breastfeeding.
  • Patients with BMI < 18 kg/m².
  • Patients with BMI > 35 kg/m².
  • Severe cardiac, pulmonary, renal, or hepatic failure.
  • Mental retardation, communication difficulties, or lack of cooperation.
  • Deformity, amputation, or large mass in the surgical extremity that may interfere with sensorimotor assessment.
  • Preoperative significant sensory loss, motor weakness, or signs of neurological disease.
  • Severe anemia (Hb < 9 g/dL) or polycythemia (Hb > 18 g/dL).
  • Psychiatric disorders, substance abuse, or any condition that may interfere with study compliance.

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: Triagem
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 90° Arm Abduction
Patients receive ultrasound-guided costoclavicular brachial plexus block with the arm positioned at 90° abduction.
Ultra-sound Guided costoclavicular brachial plexus block performed for upper extremity surgery using a standard local anesthetic technique
Experimental: 120° Arm Abduction
Patients receive ultrasound-guided costoclavicular brachial plexus block with the arm positioned at 120° abduction.
Ultra-sound Guided costoclavicular brachial plexus block performed for upper extremity surgery using a standard local anesthetic technique

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Block Onset Time
Prazo: Up to 30 minutes after block performance
Time from completion of local anesthetic injection to achievement of adequate sensory block sufficient for surgery, assessed by pinprick test.
Up to 30 minutes after block performance

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Block Success
Prazo: İntraoperative period
Successful completion of surgery without the need for additional anesthesia.
İntraoperative period
Sensory Block Score
Prazo: Baseline and at 5-minute intervals up to 20 minutes after block performance.
Sensory block was assessed using a 3-point pinprick scale ( 0= normal sensation, 1= loss of pinprick sensation, 2= complete sensory block).
Baseline and at 5-minute intervals up to 20 minutes after block performance.
Motor Block Score
Prazo: Baseline and at 5-minute intervals up to 30 minutes after block performance.
Motor block was assessed using a 3-point motor scale (0= normal motor function, 1= reduced motor strength, 20 complete motor block).
Baseline and at 5-minute intervals up to 30 minutes after block performance.
Perfusion Index
Prazo: Baseline and at 5,10,15 and 20 minutes after block performance.
Perfusion index values measured using a Masimo pulse oximeter probe placed on the blocked upper extremity.
Baseline and at 5,10,15 and 20 minutes after block performance.
Readiness for Surgery
Prazo: 15 minutes after block
Proportion of patients ready for surgery at 15 and 20 minutes.
15 minutes after block
Readiness for Surgery
Prazo: 20 minutes after block
Proportion of patients ready for surgery at 15 and 20 minutes
20 minutes after block
Block Performance Time
Prazo: During procedure ( min )
Time required to perform the block.
During procedure ( min )
Need for Additional Anesthesia
Prazo: Intraoperative period
Requirement for supplemental anesthesia or conversion to general anesthesia.
Intraoperative period
Complications
Prazo: Up to 24 hours
Early complications related to block
Up to 24 hours
Postoperative Sensory and Motor Function Assessment
Prazo: 4 hours after surgery
Postoperative neurological evaluation including sensory and motor function examination of the blocked upper extremity to assess for neurological complications.
4 hours after surgery
Postoperative Sensory and Motor Function Assessment
Prazo: 24 hours after surgery
Postoperative neurological evaluation including sensory and motor function examination of the blocked upper extremity to assess for neurological complications.
24 hours after surgery
Patient Satisfaction
Prazo: At the end of the surgery and 24 hours postoperatively
Patient satisfaction assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied.
At the end of the surgery and 24 hours postoperatively
Hemodynamic Parametres
Prazo: Baseline and at 5,10,15 and 20minutes after block performance
Heart rate
Baseline and at 5,10,15 and 20minutes after block performance
Systolic Blood Pressure
Prazo: Baseline and at 5,10,15 and 20 minutes after block performance.
Systolic blood pressure values measured during and after block performance.
Baseline and at 5,10,15 and 20 minutes after block performance.
Diastolic Blood Pressure
Prazo: Baseline and at 5,10,15 and 20 minutes after block performance.
Diastolic blood pressure values measured during and after block performance.
Baseline and at 5,10,15 and 20 minutes after block performance.
Mean Arterial Pressure
Prazo: Baseline and at 5,10,15 and 20 minutes after block performance.
Mean arterial pressure values measured during and after block performance.
Baseline and at 5,10,15 and 20 minutes after block performance.

Colaboradores e Investigadores

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

Investigadores

  • Diretor de estudo: Reyhan Polat, Professor, Ankara Etlik City Hospital

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 (Estimado)

15 de maio de 2026

Conclusão Primária (Estimado)

15 de julho de 2026

Conclusão do estudo (Estimado)

27 de agosto 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

8 de maio de 2026

Primeira postagem (Real)

14 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • AEŞH-EK-2026-07

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

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