Меню
Идёт набор NCT07180979

PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty

Фаза IV С лечением Hip Osteoarthritis Hip Arthropathy Hip Pain Chronic

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: Ropivacaine 0.5% Injectable Solution, Ropivacaine 0.2% Injectable Solution, Ropivacaine 0.2% Injectable Solution.
Кому может быть актуально
Состояния в реестре: Hip Osteoarthritis, Hip Arthropathy, Hip Pain Chronic. 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

Comparison of Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block (L-ESPB) Combined With Sacral ESPB (S-ESPB) for Analgesia in Total Hip Arthroplasty (THA): A Randomized Clinical Trial

Обзор

The goal of this clinical trial is to evaluate whether different types of regional anesthesia can improve pain control and functional recovery after total hip arthroplasty in adult patients undergoing elective hip replacement surgery. The main questions it aims to answer are: Does the PENG block reduce opioid use in the first 48 hours after surgery more effectively than the combined L-ESPB + S-ESPB technique? Which method provides better pain relief, preserves muscle strength, and supports earlier mobilization? Researchers will compare the Pericapsular Nerve Group (PENG) block with the combination of Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB + S-ESPB) to see which provides better pain control, fewer side effects, and faster recovery. Participants will: Be randomly assigned to receive one of the two types of ultrasound-guided regional anesthesia Undergo standard hip replacement surgery under spinal anesthesia Be monitored for pain scores, opioid use, time to first walking, muscle strength, satisfaction, and side effects over the first 48 hours after surgery.

Подробное описание

Total hip arthroplasty (THA) is associated with moderate-to-severe postoperative pain, which can impair early mobilization and functional recovery. Regional anesthesia techniques, such as the pericapsular nerve group (PENG) block and the erector spinae plane (ESP) block, have been introduced as motor-sparing alternatives to femoral and lumbar plexus blocks. The PENG block targets articular branches of the femoral, obturator, and accessory obturator nerves, offering effective analgesia with minimal motor blockade. Meanwhile, the lumbar ESPB (L-ESPB) and sacral ESPB (S-ESPB) may provide a broader, yet still motor-sparing, analgesic field by targeting both lumbar and sacral nerve roots involved in hip innervation.

To date, no randomized trial has compared PENG with a dual-level ESP block approach (L-ESPB + S-ESPB) in THA patients.

Вмешательства

  • Препарат Ropivacaine 0.5% Injectable Solution
    All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty.
  • Препарат Ropivacaine 0.2% Injectable Solution
    Ultrasound-guided pericapsular nerve group (PENG) block and lateral femoral cutaneous nerve (LFCN) block, with sham lumbar and sacral ESPBs. PENG block: 20 mL of 0.2% ropivacaine. LFCN block: 5 mL of 0.2% ropivacaine. Sham lumbar ESPB: 1-2 mL preservative-free normal saline at lumbar ESPB site. Sham sacral ESPB: 1-2 mL preservative-free normal saline at sacral ESPB site. All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10-15 mg intrathecally for total hip arthroplasty
  • Препарат Ropivacaine 0.2% Injectable Solution
    Ultrasound-guided lumbar erector spinae plane block (L-ESPB) and sacral erector spinae plane block (S-ESPB), with sham PENG and LFCN blocks. Lumbar ESPB: 20 mL of 0.2% ropivacaine at L3 transverse process level. Sacral ESPB: 20 mL of 0.2% ropivacaine at sacral intermediate crest. Sham PENG block: 1-2 mL preservative-free normal saline at PENG site. Sham LFCN block: 1-2 mL preservative-free normal saline at LFCN site. All patients will receive standard spinal anesthesia with 0.5% ropivacaine, 10

Первичные конечные точки

  • Total opioid consumption [Срок оценки: first 48 hours postoperatively]
Вторичные конечные точки (11)
  • Pain scores [Срок оценки: 4 hours after surgery]
  • Pain scores [Срок оценки: 8 hours after surgery]
  • Pain scores [Срок оценки: 12 hours after surgery]
  • Pain scores [Срок оценки: 24 hours after surgery]
  • Pain scores [Срок оценки: 48 hours after surgery]
  • Time to ambulation [Срок оценки: 48 hours after surgery]
  • Quadriceps muscle strength [Срок оценки: 4 hours after surgery]
  • Quadriceps muscle strength [Срок оценки: 8 hours after surgery]
  • Quadriceps muscle strength [Срок оценки: 12 hours after surgery]
  • Quadriceps muscle strength [Срок оценки: 24 hours after surgery]
  • Quadriceps muscle strength [Срок оценки: 48 hours after surgery]

Критерии участия

Критерии включения

  • Age ≥ 65 years
  • ASA physical status I-III
  • Elective unilateral THA via posterior or lateral approach
  • Informed consent provided

Критерии исключения

  • Allergy to study drugs (ropivacaine, dexamethasone)
  • Chronic opioid use (>30 MME/day)
  • Coagulopathy or infection at the injection site
  • BMI > 40 kg/m²
  • Pre-existing motor weakness or neuropathy in the affected limb
  • Cognitive impairment precluding informed consent

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

Публикации

  • Reysner T, Ciftci B, Alver S, Wieczorowska-Tobis K, Reysner M. Comparison of pericapsular nerve group block combined with a lateral femoral cutaneous nerve (LFCN) block versus lumbar and sacral erector spinae plane blocks for analgesia after total hip arthroplasty: study protocol for a randomized, controlled trial with blinded outcome assessment. Pain Manag. 2026 May 18:1-8. doi: 10.1080/17581869. PMID 42148589

Идентификаторы

NCT: NCT07180979 · 03/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗