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Идёт набор NCT07288983

PENG Block vs Suprainguinal FICB vs Lumbar ESPB for Analgesia After Hip Surgery

Без фазы С лечением Hip Osteoarthritis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pericapsular Nerve Group (PENG) Block, Suprainguinal Fascia Iliaca Compartment Block (S-FICB), Lumbar Erector Spinae Plane Block (L-ESPB).
Кому может быть актуально
Состояния в реестре: Hip Osteoarthritis. Базовые параметры: 65 лет — 100 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Randomized, Double-Blinded, Controlled Trial Comparing the Analgesic Efficacy and Motor-Sparing Properties of the Pericapsular Nerve Group (PENG) Block, Suprainguinal Fascia Iliaca Compartment Block (S-FICB), and Lumbar Erector Spinae Plane Block (L-ESPB) in Patients Undergoing Hip Arthroplasty

Обзор

This randomized, double-blinded, controlled clinical trial compares three motor-sparing regional anesthesia techniques used for postoperative analgesia in patients undergoing hip arthroplasty: the Pericapsular Nerve Group (PENG) block, the suprainguinal Fascia Iliaca Compartment Block (S-FICB), and the Lumbar Erector Spinae Plane Block (L-ESPB). Although all three techniques are widely used in modern hip surgery, their relative analgesic efficacy, opioid-sparing potential, and impact on early functional recovery have not been directly compared in a single study. The primary objective is to determine which block provides the most effective postoperative analgesia while preserving motor function and facilitating early mobilization. Secondary objectives include comparisons of opioid consumption, pain scores at rest and during movement, time to first rescue analgesia, block-related adverse events, quadriceps strength, incidence of postoperative nausea and vomiting, and early functional outcomes. This study aims to identify the optimal motor-sparing regional anesthesia strategy for older adults undergoing hip arthroplasty.

Подробное описание

Regional anesthesia plays a key role in modern multimodal analgesia for hip arthroplasty, particularly in older adults who are vulnerable to opioid-related adverse effects and postoperative functional decline. Several motor-sparing nerve block techniques have been developed to improve postoperative pain control while maintaining quadriceps strength and enabling early mobilization. Among them, the Pericapsular Nerve Group (PENG) block, the suprainguinal Fascia Iliaca Compartment Block (S-FICB), and the Lumbar Erector Spinae Plane Block (L-ESPB) are widely used in clinical practice. However, no randomized clinical trial has directly compared these three approaches within a single study population.

The PENG block targets the articular branches of the femoral, obturator, and accessory obturator nerves, providing selective analgesia of the anterior hip capsule with minimal motor involvement. The suprainguinal FICB delivers a higher spread of local anesthetic over the femoral nerve, lateral femoral cutaneous nerve, and variable portions of the obturator nerve, offering broader sensory coverage but with a higher likelihood of quadriceps weakness. The lumbar ESPB is a posterior fascial plane block that may achieve indirect spread toward the lumbar plexus, potentially providing balanced anterior and posterior capsular analgesia while preserving motor function.

This randomized, double-blinded, three-arm controlled trial aims to compare the analgesic effectiveness, opioid-sparing properties, and motor-sparing characteristics of PENG, S-FICB, and L-ESPB in patients undergoing hip arthroplasty. All participants will receive standardized spinal anesthesia and multimodal postoperative analgesia. The study's primary endpoint is the time to first rescue opioid administration. Secondary outcomes include total postoperative opioid consumption, pain scores at rest and during movement, quadriceps muscle strength, block performance time, incidence of postoperative nausea and vomiting, early mobilization parameters, and block-related adverse events.

The results of this trial are expected to clarify the relative benefits and limitations of the three most commonly used motor-sparing regional anesthesia techniques for hip surgery and to guide optimal selection of blocks for enhanced recovery pathways in older adults undergoing hip arthroplasty.

Вмешательства

  • Процедура Pericapsular Nerve Group (PENG) Block
    The Pericapsular Nerve Group (PENG) block will be performed under ultrasound guidance using a curvilinear or linear transducer. A 22-gauge echogenic needle will be advanced in-plane toward the fascial plane between the iliopsoas tendon and the pelvic brim at the level of the anterior inferior iliac spine. A total of 20 mL of 0.2% ropivacaine will be injected incrementally with repeated aspiration to avoid intravascular injection. No additional peripheral nerve blocks will be performed. All patie
  • Процедура Suprainguinal Fascia Iliaca Compartment Block (S-FICB)
    The suprainguinal fascia iliaca compartment block will be performed under ultrasound guidance using a high-frequency linear probe placed in the sagittal oblique plane above the inguinal ligament. After identifying the fascia iliaca above the iliacus muscle, a 22-gauge echogenic needle will be advanced in-plane into the suprainguinal fascia iliaca space. A total of 30 mL of 0.2% ropivacaine will be injected to achieve cranial spread toward the femoral nerve, lateral femoral cutaneous nerve, and o
  • Процедура Lumbar Erector Spinae Plane Block (L-ESPB)
    The lumbar erector spinae plane block will be performed under ultrasound guidance at the L4 transverse process level. A curvilinear or linear ultrasound probe will be used to identify the erector spinae muscle and underlying transverse process. A 22-gauge echogenic needle will be inserted in-plane and advanced to the fascial plane deep to the erector spinae muscle and superficial to the transverse process. A total of 20 mL of 0.2% ropivacaine will be injected incrementally. No sacral ESPB will b

Первичные конечные точки

  • Total Opioid Consumption in the First 48 Hours After Surgery [Срок оценки: 0-48 hours postoperatively]
Вторичные конечные точки (12)
  • Time to First Rescue Opioid Administration [Срок оценки: 0-48 hours postoperatively]
  • Numerical Rating Scale (NRS) Pain Scores at Rest [Срок оценки: 4 hours postoperatively]
  • Numerical Rating Scale (NRS) Pain Scores at Rest [Срок оценки: 8 hours postoperatively]
  • Numerical Rating Scale (NRS) Pain Scores at Rest [Срок оценки: 12 hours postoperatively]
  • Numerical Rating Scale (NRS) Pain Scores at Rest [Срок оценки: 24 hours postoperatively]
  • Numerical Rating Scale (NRS) Pain Scores at Rest [Срок оценки: 48 hours postoperatively]
  • Numerical Rating Scale (NRS) Pain Scores During Movement [Срок оценки: 4 hours postoperatively]
  • Numerical Rating Scale (NRS) Pain Scores During Movement [Срок оценки: 8 hours postoperatively]
  • Numerical Rating Scale (NRS) Pain Scores During Movement [Срок оценки: 12 hours postoperatively]
  • Numerical Rating Scale (NRS) Pain Scores During Movement [Срок оценки: 24 hours postoperatively]
  • Numerical Rating Scale (NRS) Pain Scores During Movement [Срок оценки: 48 hours postoperatively]
  • Quadriceps Muscle Strength [Срок оценки: 4 hours postoperatively]

Критерии участия

Критерии включения

  • Adults aged 65 years or older scheduled to undergo elective hip arthroplasty under spinal anesthesia.
  • Ability to provide written informed consent.
  • Ability to understand and reliably use numerical pain assessment tools (NRS 0-10).
  • ASA physical status II-III.
  • Expected postoperative hospitalization of at least 48 hours to ensure complete data collection.

Критерии исключения

  • Inability to provide informed consent due to cognitive impairment, language barrier, or severe hearing/speech limitations.
  • Coagulopathy or therapeutic anticoagulation not meeting safety criteria for regional anesthesia.
  • Local infection at the planned block site.
  • Allergy, hypersensitivity, or contraindication to ropivacaine, local anesthetics, or study medications.
  • Pre-existing lower-limb neurological deficits (motor or sensory) affecting outcome assessments.
  • Severe spinal deformity or anatomical limitations preventing safe performance of regional blocks.
  • Chronic opioid use (defined as >30 mg oral morphine equivalents daily for more than 2 weeks).
  • Severe renal failure (eGFR <30 mL/min/1.73m²) or severe hepatic impairment.
  • Uncontrolled diabetes mellitus (fasting glucose >300 mg/dL or HbA1c >10%).
  • History of local anesthetic systemic toxicity (LAST).
  • Participation in another interventional clinical trial within the past 30 days.
  • Any condition deemed by investigators to interfere with protocol adherence, safety monitoring, or outcome reliability.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Польша · 1 центр
  • Poznan University of Medical Sciences — Poznan

Идентификаторы

NCT: NCT07288983 · 14/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗