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Идёт набор NCT04209504

Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block

— Наблюдательное Shoulder Surgery Shoulder Pain Shoulder Injuries Shoulder Arthritis

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, Ropivacaine, Bupivacaine, MediPines AGM100 Advanced Respiratory Monitoring System.
Кому может быть актуально
Состояния в реестре: Shoulder Surgery, Shoulder Pain, Shoulder Injuries, Shoulder Arthritis. Базовые параметры: 18 лет — 80 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
США
Следующий шаг
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Обзор

This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. English speaking American Society of Anesthesiologists (ASA) 1-3 patients ages 18-80 receiving prolonged interscalene nerve block will be randomized into 3 groups: first group receiving a perineural catheter infusing 0.2% ropivacaine; the second group receiving a single shot injection of 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine and the third receiving 20mL liposomal bupivacaine plus 5mL bupivacaine (to be determined by the attending anesthesiologist).Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound.

Подробное описание

This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. English speaking ASA 1-3 patients ages 18-80 receiving prolonged interscalene nerve block will be randomized into 3 groups first group receiving a perineural catheter infusing 0.2% ropivacaine; the second group receiving a single shot injection of 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine and the third group receiving 20mL liposomal bupivacaine plus 5mL bupivacaine (to be determined by the attending anesthesiologist). Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound. Secondary outcomes include incidence of hemidiaphragmatic paralysis as measured by point of care ultrasound (POCUS) in the immediate postoperative period, postoperative day (POD) 1, POD2, and POD3 and noninvasive measures of pulmonary gas exchange at pre-op, post-op, POD1, POD2, and POD3. Additionally, the investigators will look at pain scores (scale of 0-10) and opioid consumption (in oral morphine equivalents) at previously defined time points listed above. Furthermore, the investigators will record known side effects of interscalene blocks including hoarseness and Horner's syndrome.

Вмешательства

  • Диагностический тест Ultrasound
    Ultrasound guided evaluation of diaphragm ipsilateral to the block side.
  • Препарат Ropivacaine
    Local anesthetic (numbing drug)
  • Препарат Bupivacaine
    Local anesthetic (numbing drug)
  • Устройство MediPines AGM100 Advanced Respiratory Monitoring System
    Non-invasive respiratory monitor to measure oxygenation and ventilation parameters

Первичные конечные точки

  • Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1 [Срок оценки: 24 hours]
Вторичные конечные точки (6)
  • Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3 [Срок оценки: up to 72 hours]
  • Noninvasive pulmonary measures of gas exchange [Срок оценки: up to 72 hours]
  • Pain scores [Срок оценки: up to 72 hours]
  • Opioid consumption [Срок оценки: up to 72 hours]
  • Hoarseness [Срок оценки: up to 72 hours]
  • Horner's Syndrome [Срок оценки: up to 72 hours]

Критерии участия

Критерии включения

  • English speaking 18-80 year old ASA 1-3 patients
  • Primary shoulder surgery
  • Must live within a 25 mile radius

Критерии исключения

  • ASA 4 or 5
  • Revision shoulder surgery
  • Diagnosis of chronic pain
  • Daily chronic opioid use (over 3 months of continuous opioid use)
  • Inability to communicate pain scores or need for analgesia
  • Infection at the site of block placement
  • Age under 18 years old or greater than 80 years old
  • Pregnant women (as determined by point-of-care serum bHCG)
  • Intolerance/allergy to local anesthetics
  • Weight <50 kg
  • BMI > 40
  • severe pulmonary disease including chronic obstructive pulmonary disease and restrictive lung disease
  • Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  • Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
  • Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • Duke University Hospital — Durham

Идентификаторы

NCT: NCT04209504 · Pro00104053

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗