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Набор скоро начнётся NCT07338630

Comparison of the Interscalene Block Alone Versus Combined With Superior Truncus Block During Shoulder Surgery in Diaphragmatic Function

Без фазы С лечением Diaphragm Issues

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 in shoulder surgery.
Кому может быть актуально
Состояния в реестре: Diaphragm Issues. Базовые параметры: 20 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

Phrenic Nerve Sparing of the Interscalene Block Alone Versus Combined With Superior Truncus Block During Shoulder Surgery , Prospective Comparative Randomized Study

Обзор

Primarily, This study aims to compare between interscalene block alone versus combined with superior truncus block in producing diaphragmatic paralysis and Secondarily aims to evaluate 1. Effect on the pulmonary function. 2. Duration of the sensory and motor block. 3. Postoperative analgesic consumption. 4. Any complications or side effects during shoulder surgery.

Подробное описание

Regional anesthesia is central to modern shoulder surgery because it provides excellent perioperative analgesia, reduces opioid consumption, and facilitates early rehabilitation. The interscalene brachial plexus block (ISB) has long been considered the gold-standard single-shot regional technique for shoulder procedures due to its reliable analgesia and surgical anesthesia. However, ISB commonly causes ipsilateral hemidiaphragmatic paresis (HDP) from unintended phrenic nerve blockade, which can produce clinically important declines in pulmonary function and may be poorly tolerated in patients with limited respiratory reserve.

To minimize phrenic involvement while preserving analgesic effectiveness, more selective approaches have been proposed. The superior trunk block (STB) - performed at the level where C5-C6 fibers form the superior trunk - aims to anesthetize the shoulder innervation more distally and thus reduce spread to the phrenic nerve. A landmark randomized trial and subsequent studies reported that STB provides analgesia comparable to ISB while greatly lowering the incidence of HDP (for example, ISB 71% vs STB 5% in one trial). Systematic reviews and meta-analyses since then have reinforced STB as an effective phrenic-sparing alternative for many shoulder procedures.

Despite encouraging data for STB, the literature is not entirely uniform. Some randomized trials and observational reports have found either reduced anesthetic quality with STB or smaller-than-expected reductions in phrenic involvement, particularly when block technique, local anesthetic volume, or patient anatomy differ. Moreover, combining blocks (for example, ISB with selective superior-trunk targeting or other modifications) has been proposed as a strategy to balance surgical anesthesia and respiratory safety, but comparative prospective data examining the effect of ISB alone versus ISB combined with STB on diaphragmatic function are limited. This uncertainty is important because even partial diaphragmatic paresis can degrade postoperative pulmonary mechanics and increase complications in vulnerable patients.

Вмешательства

  • Другое Regional anesthesia in shoulder surgery
    Comparison of the interscalene block alone versus combined with superior truncus block during shoulder surgery in diaphragmatic function

Первичные конечные точки

  • Comparison between interscalene block alone versus combined with superior truncus block inproducing diaphragmatic paralysis [Срок оценки: Assessment of diaphragmatic function by diaphragm excursion (DE) and diaphragm thickening fraction (TF) will be measured both before and 30 minutes post-block.]
Вторичные конечные точки (4)
  • Evaluation of the interscalene block alone versus combined with superior truncus block during shoulder surgery on the pulmonary function [Срок оценки: Assessment of pulmonary function by a handheld spirometer to measure forced vital capacity (FVC), forced expiratory volume ( FEV1, FEV2) with patients in an upright-seated position pre-block and 30 minutes post-block as well as 2-hours post-surgery]
  • Duration of the sensory and motor block onset, duration of the interscalene block alone versus combined with superior truncus block during shoulder surgery [Срок оценки: Sensory, motor block onset time every minute. Sensory, Motor block duration every hour in 1st 6 hours , every 2 hours in 2nd 6 hours]
  • Evaluation of postoperative analgesic consumption [Срок оценки: 12 hours]
  • Evaluation of any complications or side effects during shoulder surgery [Срок оценки: 24 hours]

Критерии участия

Критерии включения

  • ASA (American Society of Anesthesiologists) I, II physical status.
  • Aged between 20 and 65 years.
  • Male or female.
  • Body Mass index (BMI): 18-30 kg/m3.
  • Scheduled for shoulder surgery.

Критерии исключения

  • Allergy to local anesthetics.
  • Infection at the injection site.
  • Coagulation disorders.
  • Respiratory diseases ( Acute or Chronic) or Chest trauma.
  • Multiple traumatized patients.
  • Phrenic nerve injury
  • Heart failure, Cardiomyopathy.
  • Severe organ dysfunction
  • Patient refusal

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07338630 · Soh-Med--25-11-5MD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗