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Effect of Adding a Biceps Femoris Short Head Block to Adductor Canal Block for Analgesia After Total Knee Arthroplasty (BiFeS-TKA)

31 de agosto de 2026 actualizado por: Antalya Training and Research Hospital

Analgesic Efficacy of Adding a Short Head of the Biceps Femoris Muscle Block to the Adductor Canal Block in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial

Total knee arthroplasty (TKA) is frequently associated with moderate to severe postoperative pain, which may delay mobilization, increase opioid consumption, and impair functional recovery. Ultrasound-guided adductor canal block (ACB) is widely used as part of multimodal analgesia because it provides effective analgesia while preserving quadriceps muscle strength. However, ACB alone may provide insufficient analgesia for the posterior aspect of the knee. The biceps femoris short head (BiFeS) block is a novel ultrasound-guided regional anesthesia technique targeting the posterolateral sensory innervation of the knee and may enhance postoperative analgesia when combined with ACB. However, clinical evidence regarding its analgesic efficacy in patients undergoing total knee arthroplasty remains limited. This prospective, randomized, controlled trial aims to compare postoperative analgesia between ultrasound-guided adductor canal block alone and adductor canal block combined with a biceps femoris short head block in adult patients undergoing primary total knee arthroplasty under spinal anesthesia. Participants will be randomly assigned in a 1:1 ratio to receive either ACB alone or combined ACB plus BiFeS block. The primary outcome is cumulative opioid consumption during the first 48 postoperative hours. Secondary outcomes include postoperative pain intensity, time to first analgesic request, quadriceps muscle strength, functional recovery, postoperative recovery quality, postoperative nausea and vomiting, patient and surgeon satisfaction, length of hospital stay, and block-related complications.

Descripción general del estudio

Descripción detallada

Background

Total knee arthroplasty (TKA) is the definitive surgical treatment for end-stage knee osteoarthritis and is one of the most frequently performed orthopedic procedures worldwide. Despite advances in multimodal analgesic strategies, postoperative pain following TKA remains a major clinical challenge. Inadequate pain control may delay early mobilization, impair functional recovery, prolong hospitalization, increase opioid consumption, and reduce patient satisfaction. Therefore, optimization of regional anesthesia techniques continues to be an important component of enhanced recovery protocols after TKA.

Ultrasound-guided adductor canal block (ACB) has become a widely accepted motor-sparing regional analgesic technique for TKA because it provides effective analgesia to the anteromedial aspect of the knee while largely preserving quadriceps muscle strength. Nevertheless, the posterior compartment of the knee receives sensory innervation from branches of the sciatic nerve that are not consistently anesthetized by ACB alone. Consequently, residual posterior knee pain remains a common limitation of this technique.

The ultrasound-guided biceps femoris short head (BiFeS) block is a recently described regional anesthesia technique that targets the posterolateral sensory innervation of the knee through deposition of local anesthetic within the fascial plane adjacent to the short head of the biceps femoris muscle. Anatomical and preliminary clinical investigations suggest that this technique may provide additional analgesic coverage of the posterior knee while preserving motor function. However, evidence regarding its clinical efficacy as an adjunct to ACB in patients undergoing primary TKA remains limited.

Study Objectives

The objective of this study is to determine whether the addition of an ultrasound-guided BiFeS block to a standard ultrasound-guided ACB provides superior postoperative analgesia compared with ultrasound-guided ACB alone in patients undergoing primary unilateral TKA under spinal anesthesia.

Study Design

This is a prospective, single-center, parallel-group, randomized controlled clinical trial. Eligible participants will be randomly assigned in a 1:1 ratio to receive either an ultrasound-guided adductor canal block or an ultrasound-guided adductor canal block combined with a biceps femoris short head block before surgery. All patients underwent total knee arthroplasty under single-shot spinal anesthesia with 15 mg of hyperbaric bupivacaine. No periarticular local infiltration analgesia was performed by the surgical team. Postoperatively, all patients received a standardized multimodal analgesic regimen consisting of intravenous paracetamol (1 g) administered every 8 hours. Rescue analgesia consisted of intravenous tramadol (100 mg), which was administered when the Numeric Rating Scale (NRS) pain score was ≥4.

Outcome Assessment

The primary endpoint is cumulative intravenous morphine consumption (mg) from arrival in the post-anesthesia care unit until 48 hours after surgery. Secondary endpoints include postoperative pain intensity assessed using the Numeric Rating Scale (NRS), time to first rescue analgesic administration, quadriceps muscle strength, functional recovery assessed by the Timed Up and Go test and knee range of motion, quality of postoperative recovery (QoR-15), postoperative nausea and vomiting, patient and surgeon satisfaction, length of hospital stay, and block-related adverse events.

Clinical Significance

This study is designed to provide high-quality evidence regarding the potential clinical benefit of incorporating the BiFeS block into contemporary multimodal analgesic protocols for total knee arthroplasty. If the combined regional analgesic approach demonstrates improved postoperative analgesia while preserving motor function, it may represent an effective strategy to facilitate enhanced recovery after surgery and reduce perioperative opioid requirements.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

122

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: Nilgun Kavrut Ozturk, MD,Professor
  • Número de teléfono: +905334196049
  • Correo electrónico: kavrut@yahoo.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Antalya
      • Antalya, Antalya, Turquía (Türkiye), 07100
        • Antalya Training and Research Hospital
        • Contacto:
          • Nilgun Kavrut Ozturk, MD, Professor
          • Número de teléfono: +95334196049
          • Correo electrónico: kavrut@yahoo.com
        • Contacto:
        • Investigador principal:
          • Serhat Gulersen, MD,

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:

  • Scheduled for elective primary unilateral total knee arthroplasty under spinal -anesthesia.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Body mass index (BMI) <40 kg/m².
  • Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

  • Refusal to participate or inability to provide informed consent.
  • Body mass index 40 kg/m2 or higher.
  • ASA physical status IV or V.
  • Known allergy or hypersensitivity to local anesthetics, opioids, or other study -medications.
  • Pregnancy or breastfeeding.
  • Uncontrolled psychiatric disease or severe anxiety interfering with study participation.
  • Pre-existing neuromuscular disease or peripheral neuropathy involving the operative limb.
  • Chronic opioid use or opioid dependence.
  • Chronic pain syndrome requiring regular analgesic therapy.
  • Severe hepatic or renal insufficiency.
  • Contraindications to spinal anesthesia or peripheral nerve block, including -coagulopathy, thrombocytopenia, local infection at the injection site, or patient refusal.
  • Planned bilateral or revision total knee arthroplasty.

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Ultrasound-Guided Adductor Canal Block
Participants assigned to this arm will receive an ultrasound-guided adductor canal block before the induction of spinal anesthesia for primary unilateral total knee arthroplasty. All regional blocks will be performed according to a standardized study protocol. Perioperative anesthetic management, surgical procedures, and postoperative multimodal analgesia will be standardized for all participants.
An ultrasound-guided adductor canal block will be performed before the induction of spinal anesthesia using a standardized technique. Following ultrasound identification of the adductor canal, 30 mL of 0.25% bupivacaine will be injected into the adductor canal adjacent to the femoral artery to provide perioperative analgesia for primary unilateral total knee arthroplasty.
Experimental: Ultrasound-Guided Adductor Canal Block Combined With Biceps Femoris Short Head Block
Participants assigned to this arm will receive an ultrasound-guided adductor canal block combined with an ultrasound-guided biceps femoris short head block before spinal anesthesia for primary unilateral total knee arthroplasty. Both regional blocks will be performed according to a standardized study protocol. Perioperative anesthetic management, surgical procedures, and postoperative multimodal analgesic regimens will be standardized for all participants.
An ultrasound-guided adductor canal block will be performed before the induction of spinal anesthesia using a standardized technique. Following ultrasound identification of the adductor canal, 30 mL of 0.25% bupivacaine will be injected into the adductor canal adjacent to the femoral artery to provide perioperative analgesia for primary unilateral total knee arthroplasty.
An ultrasound-guided biceps femoris short head block will be performed before the induction of spinal anesthesia using a standardized technique. Following ultrasound identification of the fascial plane adjacent to the short head of the biceps femoris muscle, 20 mL of 0.25% bupivacaine will be administered to provide additional posterolateral knee analgesia as an adjunct to the adductor canal block.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cumulative Opioid Consumption
Periodo de tiempo: From arrival in the post-anesthesia care unit until 48 hours after surgery
Cumulative opioid consumption during the first 48 postoperative hours, recorded as intravenous morphine equivalent dose (mg).
From arrival in the post-anesthesia care unit until 48 hours after surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative Pain Intensity
Periodo de tiempo: 4, 8, 12, 24, and 48 hours after surgery
Postoperative pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS). Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain will be evaluated both at rest and during knee flexion. Lower scores indicate better postoperative analgesia.
4, 8, 12, 24, and 48 hours after surgery
Time to First Rescue Analgesic Administration
Periodo de tiempo: During the first 48 postoperative hours
Time from completion of surgery to the first administration of rescue analgesic medication, recorded in hours. Longer time intervals indicate prolonged postoperative analgesic effectiveness.
During the first 48 postoperative hours
Quadriceps Muscle Strength
Periodo de tiempo: Preoperatively and at 8, 24, and 48 hours after surgery
Quadriceps muscle strength will be assessed using the Manual Muscle Testing (MMT) Scale, ranging from 0 to 5, where 0 represents no visible muscle contraction and 5 represents normal muscle strength against full resistance. Higher scores indicate greater quadriceps muscle strength.
Preoperatively and at 8, 24, and 48 hours after surgery
Functional Mobility
Periodo de tiempo: 24 and 48 hours after surgery
Functional mobility will be evaluated using the Timed Up and Go (TUG) Test. The total time (seconds) required to stand from a seated position, walk 3 meters, turn, return, and sit down will be recorded. Shorter completion times indicate better functional mobility. Participants who were unable to perform the TUG test independently at 24 hours after surgery were withdrawn from the study according to the study protocol.
24 and 48 hours after surgery
Knee Range of Motion
Periodo de tiempo: Preoperatively and at 12 and 24 hours after surgery
Active knee flexion range of motion will be measured in the supine position using a standard goniometer. The maximum active knee flexion angle will be recorded in degrees.
Preoperatively and at 12 and 24 hours after surgery
Quality of Recovery at 24 Hours Assessed Using QoR-15
Periodo de tiempo: 24 hours after surgery
Recovery quality will be evaluated using the Quality of Recovery-15 (QoR-15) questionnaire. Total scores range from 0 to 150, with higher scores indicating better postoperative recovery.
24 hours after surgery
Postoperative Nausea and Vomiting
Periodo de tiempo: Incidence of postopereative nausea and/ or vomiting within 48 hours
The severity of postoperative nausea and vomiting will be assessed using a 4-point ordinal scale (0-3), where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Lower scores indicate fewer postoperative symptoms.
Incidence of postopereative nausea and/ or vomiting within 48 hours
Patient Satisfaction
Periodo de tiempo: 48 hours after surgery
Patient satisfaction with postoperative pain management will be assessed using a 5-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater patient satisfaction.
48 hours after surgery
Surgeon Satisfaction
Periodo de tiempo: At completion of surgery
Surgeon satisfaction with perioperative conditions will be assessed using a 5-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater surgeon satisfaction.
At completion of surgery
Length of Hospital Stay
Periodo de tiempo: From end of surgery to hospital discharge, assessed up to 10 days
Length of hospital stay will be defined as the time from completion of surgery until hospital discharge and will be recorded in hours. Shorter hospital stay indicates earlier postoperative recovery.
From end of surgery to hospital discharge, assessed up to 10 days
Block-Related Adverse Events
Periodo de tiempo: From block placement to hospital discharge, assessed up to 10 days
The incidence of block-related adverse events, including neurological injury, foot drop, local anesthetic systemic toxicity, hematoma, infection, allergic reactions, and myotoxicity, will be recorded. Outcomes will be reported as the number of participants experiencing each event.
From block placement to hospital discharge, assessed up to 10 days

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Serhat Gulersen, MD,, University of Health Sciences Türkiye, Antalya Training and Research 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)

1 de septiembre de 2026

Finalización primaria (Estimado)

20 de febrero de 2027

Finalización del estudio (Estimado)

20 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

3 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

31 de agosto de 2026

Publicado por primera vez (Actual)

4 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de septiembre de 2026

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

31 de agosto de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

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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