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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 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

122

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Nilgun Kavrut Ozturk, MD,Professor
  • Numer telefonu: +905334196049
  • E-mail: kavrut@yahoo.com

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

    • Antalya
      • Antalya, Antalya, Turcja (Türkiye), 07100
        • Antalya Training and Research Hospital
        • Kontakt:
          • Nilgun Kavrut Ozturk, MD, Professor
          • Numer telefonu: +95334196049
          • E-mail: kavrut@yahoo.com
        • Kontakt:
        • Główny śledczy:
          • Serhat Gulersen, MD,

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Eksperymentalny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Cumulative Opioid Consumption
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Postoperative Pain Intensity
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

  • Główny śledczy: Serhat Gulersen, MD,, University of Health Sciences Türkiye, Antalya Training and Research Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

20 lutego 2027

Ukończenie studiów (Szacowany)

20 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

3 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

4 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

31 sierpnia 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 10840098-202.3.02-446

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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