Continuous Interscalene Block Results in Superior Recovery Throughout the First Postoperative Week
Continuous Interscalene Block in Patients Having Outpatient Rotator Cuff Repair Surgery: a Prospective Randomized Trial
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Background The advantages of single injection (SISB) and continuous interscalene brachial plexus block (CISB) over general anesthesia (GA) only have been previously reported. However, few studies extended their observations beyond 48 postoperative hours, and no study has compared the effects of SISB and CISB as sole anesthesia modalities with GA only. We undertook this randomized trial to compare the recovery profile of patients receiving SISB, CISB or GA for arthroscopic rotator cuff repair surgery through the first postoperative week. Our primary hypothesis was that highest NRS pain rating (worst pain score) at the end of the study week is lower for patients in the CISB group than for patients in the SISB or GA groups.
Methods After Institutional Review Board approval and informed consents were obtained, 71 patients of American Society of Anesthesiologists (ASA) physical status I-III, ≥18 years of age, and BMI≤35 kg/m2, scheduled for elective outpatient arthroscopic rotator cuff repair, were enrolled. CISB patients received 20 mL of 0.5% ropivacaine as bolus through the catheter whereas SISB patients received the same volume of injection through a needle. CISB patients received an infusion of 0.2% ropivacaine at 5mL/h with a patient controlled bolus of 5 mL hourly. GA only patients received a standardized general anesthetic. All patients were prescribed acetaminophen (500mg) with hydrocodone (7.5mg) every 4h as needed. CISB was discontinued 48 h after surgery. Postoperative highest pain scores (NRS) through the first postoperative week, time-to-first pain, analgesic consumption, fast-tracked postoperative care unit (PACU) bypass rate, length of PACU stay, time-to-discharge home, sleep duration, and related adverse effects were recorded in the PACU and at home on postoperative days 1, 2, 3, and 7.
Тип исследования
Регистрация (Действительный)
Фаза
- Ранняя фаза 1
Контакты и местонахождение
Места учебы
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New York
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New York, New York, Соединенные Штаты, 10025
- St Luke's Roosevelt Hospital Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
American Society of Anesthesiologists (ASA) physical status I-III patients
≥ 18 years of age BMI ≤ 35 kg/m2 Scheduled for elective arthroscopic shoulder surgery
Exclusion Criteria:
Patients who were undertaken open shoulder procedures Patients with difficulty understanding the instructions for using the anesthetic infusion pump and/or pain scales Patients with contraindications to regional anesthesia (e.g., allergy to a local anesthetic (LA), local infection, coagulopathy) Patients with significant neurologic disorders of the upper extremity, psychiatric or cognitive disorders, history of substance abuse or chronic opioid use
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Single ISB (SISB) group
Patients in this group received single injection (SISB) interscalene brachial plexus block
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In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.
Другие имена:
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Активный компаратор: Continuous ISB (CISB) group
Patients in this group received continuous (CISB) interscalene brachial plexus block
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In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle. For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter.
Другие имена:
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Без вмешательства: General anesthesia (GA) group
Patients in this group received general anesthesia (GA)
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4
Временное ограничение: throughout the first postoperative week on days 1, 2, 3, and 7
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The effects of the three anesthetic techniques (continuous interscalene brachial plexus block (CISB), single interscalene brachial plexus block (SISB), or general anesthesia (GA)) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (highest NRS pain rating)
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throughout the first postoperative week on days 1, 2, 3, and 7
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Time-to-first Pain
Временное ограничение: throughout the first postoperative week
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The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (time-to-first pain).
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throughout the first postoperative week
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The Number of Patients Consume ≥1 Dose of Analgesics
Временное ограничение: throughout the first postoperative week
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The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (analgesic consumption).
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throughout the first postoperative week
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number
Временное ограничение: throughout the first postoperative week (how many patients left PACU immediately just after the operation)
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To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using fast-tracked PACU bypass rate
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throughout the first postoperative week (how many patients left PACU immediately just after the operation)
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Length of PACU Stay
Временное ограничение: throughout the first postoperative week (how long patients stayed in PACU just after the operation)
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To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using length of PACU stay.
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throughout the first postoperative week (how long patients stayed in PACU just after the operation)
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Time to Discharge Home
Временное ограничение: throughout the first postoperative week (how long patients stayed in the hospital (includes PACU and hospital time)
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To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using time-to-discharge home.
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throughout the first postoperative week (how long patients stayed in the hospital (includes PACU and hospital time)
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Total Hours of Sleep
Временное ограничение: first postoperative week (on day 7)
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To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using sleep duration.
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first postoperative week (on day 7)
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Соавторы и исследователи
Соавторы
Следователи
- Главный следователь: Admir Hadzic, MD,PhD,Prof, St. Luke's-Roosevelt Hospital Center
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 10142 (DAIDS ES)
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