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

6 de junio de 2026 actualizado 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.

Descripción general del estudio

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

106

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Algan TURGUT ÇARSANCAKLI, M.D.
  • Número de teléfono: +90 532 486 52 69
  • Correo electrónico: alganturgut@gmail.com

Copia de seguridad de contactos de estudio

  • Nombre: Reyhan POLAT, Professor
  • Número de teléfono: +90 532 673 43 10
  • Correo electrónico: reyhanp9@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Poner en pantalla
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Block Onset Time
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Block Success
Periodo de tiempo: İntraoperative period
Successful completion of surgery without the need for additional anesthesia.
İntraoperative period
Sensory Block Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 15 minutes after block
Proportion of patients ready for surgery at 15 and 20 minutes.
15 minutes after block
Readiness for Surgery
Periodo de tiempo: 20 minutes after block
Proportion of patients ready for surgery at 15 and 20 minutes
20 minutes after block
Block Performance Time
Periodo de tiempo: During procedure ( min )
Time required to perform the block.
During procedure ( min )
Need for Additional Anesthesia
Periodo de tiempo: Intraoperative period
Requirement for supplemental anesthesia or conversion to general anesthesia.
Intraoperative period
Complications
Periodo de tiempo: Up to 24 hours
Early complications related to block
Up to 24 hours
Postoperative Sensory and Motor Function Assessment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Director de estudio: Reyhan Polat, Professor, Ankara Etlik City Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de mayo de 2026

Finalización primaria (Estimado)

15 de julio de 2026

Finalización del estudio (Estimado)

27 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

7 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de mayo de 2026

Publicado por primera vez (Actual)

14 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • AEŞH-EK-2026-07

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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