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Набира участници Не е приложимо NCT07360392

BiFeS vs. iPACK in Postoperative Knee Arthroplasty Analgesia

Не е приложима фаза (напр. обсервационно)
Заболявания: Arthroplasty, Replacement, Knee Pain, Postoperative Anesthesia, Regional

Спонсор: Amasya University

Налично на: БГ
Обобщение
The Biceps Femoris Short Head (BiFeS) block is a new fascial plane block technique targeting the sensory innervation of the posterolateral capsule of the knee while preserving motor function. The aim of this study is to evaluate the postoperative analgesic efficacy of the BiFeS block combined with the adductor canal block (ACB) in patients undergoing total knee arthroplasty, compared to ACB + iPACK block. The study is planned as a prospective, randomized, double-blind, parallel two-group trial. Patients will be randomized in a 1:1 ratio to receive ACB + iPACK (Group A) or ACB + BiFeS (Group B). Postoperative pain scores (VAS), opioid consumption, early mobilization, and quality of recovery (QoR-15) outcomes will be compared.
Описание
Total knee arthroplasty (TKA) is an effective surgical method for the treatment of advanced osteoarthritis, reducing pain and improving functional capacity. However, approximately 30-40% of cases experience severe postoperative pain, and 20-31% of patients develop persistent postoperative pain (1, 2). This not only delays early mobilization and rehabilitation but also negatively affects patient satisfaction and overall recovery. Enhanced Recovery After Surgery (ERAS) protocols emphasize that effective postoperative analgesia is indispensable for early mobilization and functional recovery. Multimodal analgesic strategies, particularly combinations of motor-sparing regional anesthesia techniques, are a cornerstone of these protocols (3). One of these regional anesthesia techniques, the femoral nerve block (FNB), provides strong analgesic efficacy but reduces quadriceps strength, increasing the risk of falls. Therefore, in recent years, "motor-sparing" approaches aimed at preserving motor function have gained prominence (4). Recent high-level network meta-analyses have shown that combinations of motor-sparing regional techniques provide superior outcomes compared to single blocks. In a 2024 meta-analysis by Wang et al., including 30 randomized controlled trials (RCTs), the combination of continuous adductor canal block (cACB) + genicular nerve block (GNB) among motor-sparing approaches provided the lowest rest pain scores at 24 and 48 hours, while cACB + iPACK + GNB combination most effectively reduced pain on movement (5). In the same study, this combination also demonstrated the highest performance in functional recovery indicators, with the shortest Timed-Up-and-Go (TUG) time and greatest range of motion. Similarly, a 2025 Bayesian network meta-analysis by Migliorini et al., analyzing 77 RCTs, reported the lowest visual analog scale (VAS) scores between postoperative days 1-3 with continuous periarticular analgesia/local infiltration analgesia (PCI/LIA); this was followed by continuous FNB/PCI and continuous ACB applications, respectively (6). Both analyses emphasized that multimodal approaches, particularly combinations of ACB, iPACK, GNB, or LIA, reduce opioid consumption and support early mobilization. Another large-scale Bayesian network meta-analysis published by Xue et al. in 2024 reported that the ACB + iPACK combination significantly reduced pain at rest and on movement at 48 hours compared to single blocks (ACB, FNB, GNB, iPACK), decreased opioid consumption, and accelerated early mobilization (7). However, current techniques have several limitations. LIA is surgeon-dependent, requires a large local anesthetic volume (100-150 mL), and shows variable efficacy due to a lack of standardization in composition/concentration. High volumes also increase the risk of local anesthetic systemic toxicity (LAST). While FNB provides effective pain control, it is not compatible with motor-sparing goals due to quadriceps weakness. Continuous bloc
Кой може да участва
Inclusion Criteria: * Scheduled for unilateral total knee arthroplasty * Classified as ASA physical status I-III Exclusion Criteria: * Scheduled for revision arthroplasty or bilateral surgery * Allergy to local anesthetics or contraindication to regional blocks * Neurological disorders, peripheral neuropathy, or conditions affecting lower extremity muscle strength * Coagulopathy or receiving anticoagulant therapy * History of severe liver, kidney, or heart failure * Chronic opioid use or history of substance abuse * Patients experiencing intraoperative complications (e.g., excessive bleeding) * Cases in which adequate sensory blockade is not achieved after the block
Интервенции
Biceps Femoris Short Head Block (BiFeS)
PROCEDURE
Infiltration Between The Popliteal Artery and The Capsule of The Knee
PROCEDURE
Adductor Canal Block
PROCEDURE
Места на провеждане 1
Турция (1)
Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital
Amasya
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
20.04.2026
Крайна дата
01.06.2027
Регистрационен номер
NCT07360392
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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