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Набор скоро начнётся NCT07595406

Cervical Medial Branch Block Versus Ipsilateral Cervical Erector Spinae Plane Block

Без фазы С лечением Cervical Facetogenic Pain Chronic Neck Pain Cervical Facet Joint Syndrome

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: Ultrasound-guided cervical medial branch block, Ultrasound-guided cervical erector spinae plane block.
Кому может быть актуально
Состояния в реестре: Cervical Facetogenic Pain, Chronic Neck Pain, Cervical Facet Joint Syndrome. 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Ultrasound-Guided Cervical Medial Branch Block Versus Ipsilateral Cervical Erector Spinae Plane Block in Cervical Facetogenic Pain: A Prospective Randomized Controlled Study

Обзор

This prospective randomized controlled study aims to compare the analgesic effectiveness of ultrasound-guided cervical medial branch block and ipsilateral cervical erector spinae plane block in patients with cervical facetogenic pain. Patients with chronic cervical facet-mediated pain will be randomized into two intervention groups. Pain intensity, functional status, meaningful pain response rates, analgesic consumption, and patient satisfaction will be evaluated during follow-up. The primary objective is to determine whether cervical erector spinae plane block provides comparable short-term pain relief to cervical medial branch block.

Подробное описание

Cervical facet joints are an important source of chronic axial neck pain. Diagnostic cervical medial branch block is commonly used to identify facet-mediated pain and may also provide short-term analgesic benefit. However, this procedure requires precise targeting of the cervical medial branches and may be technically demanding in some patients.

The cervical erector spinae plane block is an ultrasound-guided interfascial plane block that may provide analgesia through cranio-caudal spread of local anesthetic along the paraspinal fascial plane. Although it has been increasingly used for perioperative and chronic pain indications, its role in cervical facetogenic pain has not been clearly established.

This study will compare the short-term analgesic effectiveness of ultrasound-guided cervical medial branch block and ipsilateral cervical erector spinae plane block in patients with clinically suspected cervical facetogenic pain. Eligible patients will be randomized to receive one of the two ultrasound-guided interventions. Pain intensity, functional disability, meaningful pain response, analgesic use, patient satisfaction, and procedure-related adverse events will be assessed during follow-up.

The study is designed to determine whether cervical erector spinae plane block can provide clinically meaningful pain relief comparable to cervical medial branch block in this patient population.

Вмешательства

  • Другое Ultrasound-guided cervical medial branch block
    Ultrasound-guided cervical medial branch block performed at clinically suspected symptomatic cervical facet levels using local anesthetic for diagnostic and analgesic purposes.
  • Другое Ultrasound-guided cervical erector spinae plane block
    Ultrasound-guided ipsilateral cervical erector spinae plane block performed at the symptomatic cervical level using local anesthetic for analgesic purposes.

Первичные конечные точки

  • Meaningful Pain Response [Срок оценки: Time Frame: 1 hour after the procedure]
Вторичные конечные точки (7)
  • NRS24 [Срок оценки: at 24 Hours]
  • NRS1 [Срок оценки: 1 week after the procedure]
  • NDI [Срок оценки: Baseline and 1 week after the procedure]
  • GPE [Срок оценки: 1 week after the procedure]
  • Analgesic Consumption [Срок оценки: 24 hours and 1 week after the procedure]
  • Patient Satisfaction [Срок оценки: 1 week after the procedure]
  • Complications [Срок оценки: Perioperative/Periprocedural]

Критерии участия

Критерии включения

  • Age between 18 and 80 years
  • Chronic neck pain lasting at least 3 months
  • Clinical findings suggestive of cervical facetogenic pain
  • Numeric Rating Scale pain score ≥4
  • Ability to provide informed consent

Критерии исключения

  • Cervical radiculopathy or myelopathy
  • Major neurological deficit
  • Infection at the injection site
  • Coagulopathy or anticoagulant therapy contraindicating intervention
  • Allergy to local anesthetics
  • Pregnancy
  • Previous cervical interventional pain procedure within the last 3 months
  • Severe psychiatric disease

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
Простое слепое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ankara Bilkent City Hospital — Ankara

Публикации

  • Elsharkawy H, Ince I, Hamadnalla H, Drake RL, Tsui BCH. Cervical erector spinae plane block: a cadaver study. Reg Anesth Pain Med. 2020 Jul;45(7):552-556. doi: 10.1136/rapm-2019-101154. Epub 2020 Apr 21. PMID 32321860

Идентификаторы

NCT: NCT07595406 · 123456

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗