Paravertebral Catheters for Pancreatic Surgery
Ultrasound Guided Bilateral Paravertebral Catheters Versus Thoracic Epidural Analgesia for Post- Operative Pain Control in Open Pancreatic Surgery: A Prospective Outcomes Study
Design: Level I randomized prospective outcomes study comparing two groups of patients. One group will receive bupivacaine and dilaudid thoracic epidural analgesia (PCA) post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively and a PCA.
Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients presenting to the University of Minnesota Medical Center for elective open pancreatic surgery.
Primary Objective: To determine if bilateral paravertebral catheters in patients with open pancreatic procedures result in decreased pain compared to patients treated with thoracic epidural for post-operative pain.
Secondary Objectives:
- To determine whether the use of bilateral paravertebral catheters impacts the length of ICU and hospital stay for patients, compared to a thoracic epidurals in patients undergoing elective open pancreatic surgery.
- To determine whether the use of ultrasound guided bilateral paravertebral catheters leads to lower risk of complications, compared to use of a thoracic epidural in patients undergoing open pancreatic surgery.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Design: Level I randomized prospective outcomes study comparing two groups of patients. One group will receive buipvacanine and dilaudid thoracic epidural analgesia (PCA) post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively and a PCA.
Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients presenting to the University of Minnesota Medical Center for elective open pancreatic surgery.
Primary Objective: To determine if bilateral paravertebral catheters in patients with open pancreatic procedures result in decreased total maximal pain scores compared to patients treated with thoracic epidural for post-operative pain.
Secondary Objectives:
- To determine whether the use of bilateral paravertebral catheters impacts the length of ICU and hospital stay for patients, compared to a thoracic epidurals in patients undergoing elective open pancreatic surgery.
- To determine whether the use of ultrasound guided bilateral paravertebral catheters leads to lower risk of complications, compared to use of a thoracic epidural in patients undergoing open pancreatic surgery.
2. Synopsis and Medical Application:
Specific Aims:
Primary Hypothesis: Paravertebral catheters will result in improved pain control relative to thoracic epidural for post-operative pain from open pancreatic surgery.
Secondary Hypothesis: Paravertebral catheters will result in fewer hospital days and improved subjective respiratory function compared to patients in the thoracic epidural group.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
Minnesota
-
Minneapolis, Minnesota, Соединенные Штаты, 55455
- University of Minnesota
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- • All patients undergoing open pancreatic surgery.
Exclusion Criteria:
• Previous difficult airway or multiple previous intubations
- History of myasthenic syndrome
- Systemic infection
- Pre-existing sensory deficit
- PT >14 or PTT >40 sec
- Platelet count less than 50,000
- Creatinine > 1.5
- Allergy to local anesthetics
- Patients who remain intubated for one week after surgery or who are unable to provide information as to their feelings of pain post-operatively for the first week post-operatively
- Use of a spinal or epidural anesthetic for surgery
- Daily use of opioid for more than a week or chronic pain syndrome
- Lack of patient cooperation
Contraindication to regional anesthesia
- Infection at injection site
- Inability to guarantee sterile equipment or sterile conditions for the block
- Patient refusal
- Risk of local anesthetic toxicity
- Coagulopathy or bleeding disorder
- Severe respiratory disease (where the patient depends on intercostal muscle function for ventilation);
- Ipsilateral diaphragmatic paresis;
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Standard of Care
Epidural placed for postoperative pain control
|
A mid thoracic epidural is placed preoperatively and a local anesthetic and opioid infusion is run postoperatively
|
|
Экспериментальный: Experimental Intervention
Bilateral paravertebral catheters placed for postoperative pain control
|
Bilateral paravertebral catheters are placed and a local anesthetic infusion via an elastomeric pump is run postoperatively
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
total Maximal Pain scored via NRS 0-10 scale
Временное ограничение: on postoperative day 1 through postoperative day 5
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 1 through postoperative day 5
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Maximal Pain scored via NRS 0-10 scale
Временное ограничение: on postoperative day 1
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 1
|
|
Maximal Pain scored via NRS 0-10 scale
Временное ограничение: on postoperative day 2
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 2
|
|
Maximal Pain scored via NRS 0-10 scale
Временное ограничение: on postoperative day 3
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 3
|
|
Maximal Pain scored via NRS 0-10 scale
Временное ограничение: on postoperative day 4
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 4
|
|
Maximal Pain scored via NRS 0-10 scale
Временное ограничение: on postoperative day 5
|
maximal pain scored via NRS 0-10 scale assessed by independent assessor
|
on postoperative day 5
|
|
Nausea/vomiting
Временное ограничение: the first five days postoperatively
|
the presence of nausea and or vomiting endorsed by the patient as assessed by an independent assessor
|
the first five days postoperatively
|
|
Length of stay
Временное ограничение: when the patient meets discharge criteria or is discharged home, expected length of stay 10 days
|
up through the time the patient is discharged , expected length of stay 10 days.
|
when the patient meets discharge criteria or is discharged home, expected length of stay 10 days
|
Соавторы и исследователи
Спонсор
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 (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 1203M11482
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .