Идёт набор NCT07284615

Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration for Postoperative Analgesia in Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial

Без фазы С лечением Arthropathy of Hip Hip Arthropathy Locoregional Anesthesia Complication of Anesthesia

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: PENG plus LFCN block, PENG plus WI.
Кому может быть актуально: Состояния в реестре: Arthropathy of Hip, Hip Arthropathy, Locoregional Anesthesia, Complication of Anesthesia. Базовые параметры: от 18 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: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration (WI) Combined With Pericapsular Nerve Group (PENG) Block for Analgesia in Elective Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial

Обзор

This prospective, randomized controlled trial aims to compare two multimodal regional anesthesia strategies for postoperative analgesia in elective total hip arthroplasty (THA) performed via anterior approach. Patients will be randomized to receive either a Pericapsular Nerve Group (PENG) block combined with a Lateral Femoral Cutaneous Nerve (LFCN) block, or a PENG block combined with wound infiltration (WI). The primary outcome is postoperative pain intensity at rest, measured by Numerical Rating Scale (NRS) at 6 hours after surgery. Secondary outcomes include dynamic pain scores at 6, 24, and 48 hours, total opioid consumption, time to first rescue analgesia, quadriceps strength, hip flexion angle, length of stay, and adverse events. All procedures are routinely used in clinical practice and carry minimal additional risk. Safety will be continuously monitored by the Principal Investigator and the study team according to an internal Safety Monitoring Plan.

Вмешательства

Процедура PENG plus LFCN block
The experimental arm will be subjected to a combination of peripheral blocks: the interfascial block of the PENG and the perinervous block of the LFCN The PENG block involves deposition of local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus. The LFCN block consists of applying local anesthetic near the nerve. The LFCN lies in the subcutaneous plane deep to the fascia lata below the anterior superior ischiatic spine.
Процедура PENG plus WI
The control arm will receive a combination of pericapsular nerve group (PENG) block and wound infiltration (WI). The PENG block involves the deposition of local anesthetic in the fascial plane between the psoas tendon and the superior pubic ramus, under ultrasound guidance. The wound infiltration consists of the administration of local anesthetic into the subcutaneous tissue along the surgical incision

Первичные конечные точки

Pain at rest control at 6h [Срок оценки: six hours after performing the regional anesthesia technique]

Вторичные конечные точки (12)

Pain at rest control at 24h [Срок оценки: 24 hours after performing the regional anesthesia technique]
Pain at rest control at 48h [Срок оценки: 48 hours after performing the regional anesthesia technique]
Pain on movement control at 6h [Срок оценки: six hours after performing the regional anesthesia technique]
Pain on movement control at 24h [Срок оценки: 24 hours after performing the regional anesthesia technique]
Pain on movement control at 48h [Срок оценки: 48 hours after performing the regional anesthesia technique]
MRC at 6h [Срок оценки: six hours after performing the regional anesthesia technique]
MRC at 24h [Срок оценки: 24 hours after performing the regional anesthesia technique]
MRC at 48h [Срок оценки: 48 hours after performing the regional anesthesia technique]
time to first PRN opioid request [Срок оценки: Time Frame: From date of surgery until up to 48 hours after]
MME of PRN opioid total doses [Срок оценки: From date of surgery until up to 48 hours after]
Complication [Срок оценки: From date of surgery until up to 48 hours after]
the degree of hip flexion at 6h [Срок оценки: six hours after performing the regional anesthesia technique]

Критерии участия

Критерии включения

Age > 18 years
Elective total hip arthroplasty
Spinal (subarachnoid) anesthesia
Written informed consent provided by the patient or by the legal guardian, if appointed