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Набор скоро начнётся NCT07324681

Evaluation of Irisin Levels in Adult Forearm Fracture Surgery Under Infraclavicular Block and General Anesthesia

Без фазы С лечением Inflamation Healing Angiogenesis

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: General Anesthesia (GA), Infraclavicular Brachial Plexus Blocks.
Кому может быть актуально
Состояния в реестре: Inflamation, Healing, Angiogenesis. Базовые параметры: 18 лет — 65 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Evaluation of Irisin Levels in Adult Patients With Forearm Fractures Undergoing Surgery With Infraclavicular Block and General Anesthesia

Обзор

This randomized prospective study evaluates the effect of general anesthesia versus infraclavicular nerve block on perioperative serum irisin levels in adults undergoing forearm fracture surgery. Irisin levels will be measured preoperatively, at 30 minutes postoperatively, and at 24 hours postoperatively. The association between irisin changes and fracture healing will be explored as a secondary outcome.

Подробное описание

Forearm fractures are common injuries in adults and frequently require surgical intervention due to instability and displacement. Postoperative recovery quality and fracture healing are influenced by multiple factors, including the type of anesthesia administered during surgery. However, the biochemical and metabolic effects of different anesthesia techniques on bone healing remain insufficiently explored.

Irisin is a myokine derived from the cleavage of fibronectin type III domain-containing protein 5 (FNDC5) and plays a significant role in muscle-bone crosstalk. Experimental and clinical studies have demonstrated that irisin promotes osteoblast differentiation, inhibits osteocyte apoptosis, and contributes to bone homeostasis and fracture healing. Despite its potential importance, the relationship between anesthesia techniques and perioperative irisin levels has not been previously investigated.

This single-center, randomized, prospective clinical trial aims to compare the effects of general anesthesia and infraclavicular brachial plexus block on perioperative serum irisin levels in adult patients undergoing elective forearm fracture surgery. Patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be randomly assigned to one of two groups: general anesthesia (Group G) or infraclavicular block (Group B).

Serum irisin levels will be measured at three time points: preoperatively, 30 minutes postoperatively, and 24 hours postoperatively. In addition to biochemical outcomes, intraoperative hemodynamic parameters (heart rate, blood pressure, oxygen saturation), analgesic consumption, and demographic data will be recorded. Postoperative radiographs will be evaluated to monitor fracture healing and callus formation, which will be analyzed as a secondary outcome in relation to changes in irisin levels.

The primary outcome of the study is the comparison of perioperative changes in serum irisin levels between the two anesthesia techniques. Secondary outcomes include the relationship between irisin level changes and radiological fracture healing, as well as differences in perioperative physiological stress responses.

This study aims to improve understanding of the metabolic and biochemical effects of anesthesia techniques on bone healing. The findings may contribute to the selection of anesthesia methods that minimize physiological stress and potentially enhance postoperative recovery and fracture healing in patients undergoing forearm fracture surgery.

Вмешательства

  • Процедура General Anesthesia (GA)
    General anesthesia administered according to institutional routine; anesthetic drugs and doses will be recorded.
  • Процедура Infraclavicular Brachial Plexus Blocks
    Ultrasound-guided infraclavicular block performed preoperatively; details of technique, local anesthetic drugs and doses will be recorded.

Первичные конечные точки

  • Change in Serum Irisin Levels [Срок оценки: Preoperative (baseline), 30 minutes postoperatively, and 24 hours postoperatively]
Вторичные конечные точки (1)
  • Radiological Fracture Healing and Callus Formation [Срок оценки: Postoperative follow-up period (up to 6 months)]

Критерии участия

Критерии включения

  • Adults aged 18 to 65 years

Scheduled for elective forearm fracture surgery

Planned to receive either general anesthesia or infraclavicular brachial plexus block

American Society of Anesthesiologists (ASA) physical status I-III

Able to provide written and verbal informed consent

Критерии исключения

  • Age <18 years or >65 years

Emergency surgery

Refusal or inability to provide informed consent

ASA physical status IV or V

Known bone diseases or metabolic bone disorders

Multiple trauma or associated organ injury

Inability to mobilize

Morbid obesity (BMI >40 kg/m²)

Renal failure

Hepatic failure

Neurological deficits or sequelae

Contraindication or allergy to any anesthetic agents used in the study

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
Открытое
Основная цель
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Bostrom P, Wu J, Jedrychowski MP, Korde A, Ye L, Lo JC, Rasbach KA, Bostrom EA, Choi JH, Long JZ, Kajimura S, Zingaretti MC, Vind BF, Tu H, Cinti S, Hojlund K, Gygi SP, Spiegelman BM. A PGC1-alpha-dependent myokine that drives brown-fat-like development of white fat and thermogenesis. Nature. 2012 Jan 11;481(7382):463-8. doi: 10.1038/nature10777. PMID 22237023

Идентификаторы

NCT: NCT07324681 · TABED 1-25-1099

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗