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Volumen mínimo efectivo de anestésico local para bloqueo de tronco superior guiado por ecografía

4 de noviembre de 2026 actualizado por: Prof Manoj K Karmakar, Chinese University of Hong Kong

Volumen mínimo efectivo de anestésico local de levobupivacaína al 0,5 % necesario para el bloqueo del tronco superior guiado por ecografía para la cirugía de hombro

The objective of this study is to identify the minimum effective dosage of a commonly used local anaesthetic drug "levobupivacaine" required to produce an effective ultrasound guided (USG) superior trunk block (STB) in at least 90% of patients for shoulder arthroscopic surgeries.

Descripción general del estudio

Estado

Reclutamiento

Intervención / Tratamiento

Descripción detallada

Shoulder arthroscopic surgery is one of the most commonly performed procedures worldwide, and associated with significant postoperative pain. Currently, such surgery is performed either under general anaesthesia or under Interscalene brachial plexus block (ISBPB), which is a regional anaesthesia technique. However, ISBPB is associated with the highest incidence of hemi-diaphragmatic palsy of the operative side. Since majority of the innervation to the shoulder arises from or passes through the superior trunk of the brachial plexus, superior trunk block has been shown to have lesser impact on the phrenic nerve and it has been gaining popularity worldwide. Ultrasound is widely used for brachial plexus block and current evidence indicates that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks (superior, middle, and inferior trunks). However, there are no data describing an optimal volume of local anaesthetic for superior trunk block. The aim of this study is to identify the minimum effective dosage of a commonly used local anaesthetic drug "levobupivacaine" required to produce an effective ultrasound guided (USG) superior trunk block (STB) in at least 90% of patients for shoulder arthroscopic surgeries.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

25

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: Ayla Wong, RN, BN
  • Número de teléfono: +85235056157
  • Correo electrónico: aylawong@cuhk.edu.hk

Ubicaciones de estudio

    • New Territories
      • Shatin, New Territories, Hong Kong
        • Reclutamiento
        • Department of Anaesthesia & Intensive Care, Prince of Wales Hospital
        • Contacto:
          • Winnie Samy, RN, BN, MSc
          • Número de teléfono: +85235052734
          • Correo electrónico: wsamy@cuhk.edu.hk

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

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status I-III scheduled to undergo elective upper shoulder arthroscopic rotator cuff repair procedure

Exclusion Criteria:

  • Patient refusal
  • pregnancy
  • skin infection at the site of block placement
  • history of allergy to local anaesthetic drugs
  • bleeding tendency or with evidence of coagulopathy
  • pre-existing neurological deficit or neuromuscular disease.

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: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: Levobupivacaine

Superior trunk nerve block will be done under ultrasound guidance to patients scheduled for shoulder surgeries. Local anesthetic agent (0.5% levobupivacaine) 8ml will be injected at the superior trunk of the brachial plexus in order to produce surgical anesthesia or analgesia for shoulder surgeries.

This study adopts a "Modified Narayana rule (MNR)", a sequential up-and-down pharmacodynamics method (UDM) to estimate the minimum effective local anesthetic volume of 90% (MELVA90) of cases of the aforementioned local anesthetic (LA), in order to produce the surgical anesthesia of the patients scheduled for shoulder surgeries. Based on the principal investigator's clinical experience, the initial volume of 8ml will be used. Depending on the success or failure of the superior trunk block, which is defined as the readiness for surgery at 30 minutes after the block, the volume for the next patient will be adjusted up or down by 2ml. The upper dose limit of the study to minimize the potential for local anesthetic systemic toxicity will be 16ml and the lower dose limit will be 4ml, which will be of no clinical importance.

Otros nombres:
  • Bloqueo de nervios periféricos

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes of sensory & motor blockade (Readiness for surgery) of the upper extremity
Periodo de tiempo: within 45 minutes after the block at 5 minutes interval

The first exact timing (in minutes) [Readiness for surgery] that an Overall sensory score =<30 (NRS: 0-100; 100=normal sensation, 0=no sensation) using ice test and a motor grade =<1 (3 point scale: 2=no block, 1=paresis, 0=paralysis) in the nerves (C5 to C6) tested that are supplied by superior trunk of brachial plexus. Sensation to coldness (ice) will be tested at C5 - Lateral (radial) side of the antecubital fossa (just proximal to elbow crease); C6 - Thumb, dorsal surface, proximal phalanx. Motor block will be graded using a 3-points scale: 2=no block, 1=paresis and 0=paralysis, and will be test at C5 - elbow flexors and C6 - wrist extensors. "Block failure" will be defined as inability to achieve "readiness for surgery" at 30 minutes after the completion of the block.

within 45 minutes after the block at 5 minutes interval
Minimum effective volume (ml) of local anesthetic agent
Periodo de tiempo: after nerve block till end of surgery

The lowest volume (in milliliters) of local anesthetic agent that can produce an effective superior trunk block for surgery. Effective superior trunk block is defined as an overall sensory score of NRS =<30 and a motor grade of =<1 during the assessment after the nerve block that can undergo surgery. Sensory assessment will be done by using ice (cold sensation) test in both dermatomes (C5, C6) and a motor grade of =<1 in both myotome (C5, C6) tested. Sensory block will be graded as 0 to 100 where 100 represents normal sensation and 0=no sensation to coldness (ice cube).

after nerve block till end of surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes of motor blockade of the upper extremity
Periodo de tiempo: within 45 minutes after the block at 5 minutes interval

Motor blockade will be graded using a 3-point scale: 2=no block, 1=paresis and 0=paralysis. Motor blockade of each individual nerve in the anaesthetized upper extremity will be evaluated by testing C5 - elbow flexors, C6 - Wrist extensors, C7 - Elbow extensors, C8 - Finger flexors to the middle finger, and T1 - small finger abductors. Onset of Motor block for each nerve will be defined as the time it took to achieve motor score =<1.

within 45 minutes after the block at 5 minutes interval
Changes of sensory block of the upper extremity
Periodo de tiempo: within 45 minutes after the block at 5 minutes interval

Sensation to coldness (ice) will be test at C5- lateral (radial) side of the antecubital fossa (just proximal to elbow crease), C6 - Thumb, dorsal surface, proximal phalanx, C7 - middle finger, dorsal surface, proximal phalanx, C8 - Little finger, dorsal surface, proximal phalanx, and T1 - medial (ulnar) side of the antecubital) fossa, just proximal to the medial epicondyle of the humerus. Sensory block, defined as loss of sensation to cold (ice), will be graded using a numeric rating scale (NRS: 0-100, 100=normal sensation, 0=no sensation).

Onset of sensory block for each nerve will be defined as the time that it took to achieve a sensory block score of NRS =<30.

within 45 minutes after the block at 5 minutes interval
Percentage changes of the Diaphragmatic function
Periodo de tiempo: Baseline (before block) and at 30 minutes after block

Excursion of the ipsilateral hemidiaphragm will be measured by ultrasound machine in supine position via the anterior subcostal route. The movement of the diaphragm will be measured in centimetres. The range of diaphragmatic excursion will be recorded from the resting expiratory position to deep inspiration (sigh test) as will be the range of diaphragmatic movement from resting expiratory position when quickly inspiring through the nose (sniff test). The decrease in diaphragmatic excursion will be calculated as the difference (in %) in diaphragmatic excursion measured before and 30 minutes after superior trunk block (STB).

Baseline (before block) and at 30 minutes after block
Changes of the Extensiveness of Diaphragmatic function
Periodo de tiempo: calculated after block

After obtaining the percentage changes of the diaphragmatic function, if the reduction in diaphragmatic excursion of more than 75%, or no movement, or paradoxical movement will be considered as complete paresis. Reduction in diaphragmatic excursion of both sigh and sniff test between 25% and 75% will be considered as partial paresis and diaphragmatic excursion of less than 25% will be considered as 'no paresis'.

calculated after block
Block performance time
Periodo de tiempo: assess once before surgery

The time taken from the start of the local anesthetic skin infiltration to the end of the injection of study drug for the nerve block.

assess once before surgery
Discomfort score
Periodo de tiempo: assess once before surgery

the degree of discomfort during the nerve block (NRS: 0-100; 0= no discomfort, 100 = very uncomfortable)

assess once before surgery
Paresthesia
Periodo de tiempo: during the period of undergoing the nerve block

Any incidence of paresthesia during the nerve block

during the period of undergoing the nerve block
Complications
Periodo de tiempo: during the nerve block till the end of surgery

Any complications during and right after the nerve block directly related to local anesthetic toxicity, vascular or pleural puncture,intraneural injection with nerve swelling.

during the nerve block till the end of surgery

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Manoj K Karmakar, MD, Chinese University of Hong Kong

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 (Actual)

19 de enero de 2023

Finalización primaria (Estimado)

31 de marzo de 2027

Finalización del estudio (Estimado)

31 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

9 de junio de 2021

Primero enviado que cumplió con los criterios de control de calidad

23 de junio de 2021

Publicado por primera vez (Actual)

28 de junio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

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

4 de noviembre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • CREC.2021.184-T

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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