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Идёт набор NCT07072286

RELIEVED (REgionaL anesthesIa PElVic fracturEs stuDy) Study. Regional Anesthesia (RA) Techniques for Pain Management in Pelvic Fractures: A Prospective, Monocentric, Pilot Cohort Study.

— Наблюдательное Pelvic Bone Injury Pelvis Injury Acetabular Fractures Acetabular Surgery

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: Regional Anesthesia, Multimodal analgesia.
Кому может быть актуально
Состояния в реестре: Pelvic Bone Injury, Pelvis Injury, Acetabular Fractures, Acetabular Surgery. 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 →

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Официальное название

RELIEVED (REgionaL anesthesIa PElVic fracturEs stuDy) Study. Regional Anesthesia (RA) Techniques for Pain Management in Pelvic Fractures: A Prospective, Monocentric, Pilot Cohort Study. Pain Management in Surgical and Conservative Settings."

Обзор

The goal of this observational clinical trial is to assess the impact of Regional Anesthesia (RA) techniques with the strongest anatomical and scientific support in controlling acute post-operative pain in pelvic/acetabular fractures, as well as their potential role in reducing complications related to excessive intra- and postoperative opioid use. The main questions it aims to answer are: Does RA lower opioid use in the first 24 hours after pelvic/acetabular fractures surgery? Does RA lower pain scores in the first 48 hours after surgery, incidence of complications and occurrence of persistent post-surgical pain? During the hours and days following surgery, the research team will evaluate and assess the intensity of any postoperative pain at predefined time points; quantify the use of pain medications and any related complications; and measure the possible onset of chronic pain and the timeline of functional recovery (through scheduled clinical follow-up at 30, 60, and 90 days). Participants will: at the time of surgery, and only in the presence of trained and certified anesthesiologists, patients will receive regional anesthesia techniques in addition to the standard multimodal analgesic treatment. In the absence of certified anesthesiologists, patients will be treated exclusively with systemic multimodal analgesia according to the standard protocol. All the procedures are part of the current clinical practice and no experimental techniques or medications are involved.

Вмешательства

  • Процедура Regional Anesthesia
    * Supra-inguinal fascia iliaca block (SIFI) * Lumbar erector spinae plane block (ESP) * Transmuscular quadratus lumborum block (QLB) All blocks will be performed by experienced anesthesiologists under ultrasound guidance, using long-acting anesthetics (ropivacaine) at fixed concentrations and doses within weight-based safety limits.
  • Препарат Multimodal analgesia
    All enrolled subjects will be treated according to the standard analgesic protocol for pelvic fractures, in accordance with available literature and institutional guidelines. Specifically, the protocols include the use of multimodal analgesia techniques in line with current clinical practice, including paracetamol, non-steroidal anti-inflammatory drugs, opioids.

Первичные конечные точки

  • Opioid consumption [Срок оценки: Up to 24 hours after surgery]
Вторичные конечные точки (5)
  • Pain Scores [Срок оценки: post-operatively at 6, 12, 24 and 48 hours following surgery]
  • Persistent post-surgical pain [Срок оценки: 30, 60, 90-days after surgery]
  • Opioids Side Effects [Срок оценки: Up to 48 hours after surgery]
  • RA side effects [Срок оценки: Up to 48 hours after surgery]
  • Hospital length of stay [Срок оценки: From surgery up to the first follow up at 30 days]

Критерии участия

Критерии включения

  • Age ≥ 18 years and ability to provide informed consent
  • Patients with pelvic/acetabular fractures requiring surgery

Критерии исключения

  • Age < 18 years
  • Absolute contraindications to ALR techniques (uncorrectable coagulopathies, known allergy to local anesthetics, technical impossibility of execution)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Италия · 1 центр
  • Centro Traumatologico Ortopedico (CTO) - AOU Città della Salute e della Scienza Univeristy — Turin

Идентификаторы

NCT: NCT07072286 · 00179/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗