Obturator and Femoral Nerve Block in Patients With Hip Fracture
Analgesic Effect of an Obturator Nerve Block Combined With a Femoral Nerve Block Compared With Femoral Nerve Block Alone in Patients With Hip Fracture
A higher number than expected of patients with hip fracture have only insufficient analgesic effect of a femoral nerve block, which is the nerve block commonly used for this group of patients. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve.
With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve.
The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
A higher number than expected of all patients with hip fracture have only insufficient analgesic effect of a femoral nerve block. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve. Earlier it was believed that the so called '3-in-1-block' or the iliac fascia compartment block would anesthetize also the obturator nerve, and these two nerve blocks have been uses extensively in the emergency ward for preoperative analgesia. Today that is not believed to be true and consequently is the part of the obturator nerve in patients with hip fracture unknown.
With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve before it branches into an anterior and a posterior branch. A selective nerve block of the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done.
The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Фаза 4
Контакты и местонахождение
Места учебы
-
-
-
Aarhus, Дания, 8000
- Рекрутинг
- Aarhus University Hospital
-
Контакт:
- Thomas D. Nielsen, MD
- Номер телефона: +45 28782877
- Электронная почта: thomas.dahl.nielsen@clin.au.dk
-
Контакт:
- Thomas F. Bendtsen, MD, Ph.d.
- Номер телефона: +45 51542997
- Электронная почта: tfb@dadlnet.dk
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Clinical suspicion of hip fracture
- Age ≥ 55 years
- Mentally capable of comprehending and using verbal pain score
- Mentally capable of differentiating between pain from the fractured hip and pain from other locations
- Mentally capable of understanding the given information
- Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call
- Verbal numeric pain scale score (NRS 0-10) > 5 with a dynamic test OR NRS > 3 at rest
- Patients informed consent
Exclusion Criteria:
- Hip fracture not confirmed by x-ray
- Weight < 40 kg
- Patient has previously been included in this trial
- If the patient wishes to be excluded
- Allergy to local anesthetics or adrenocortical hormone
- Visible infection in the area of the point of needle injection
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Bupivacaine
Obturator nerve block
|
Obturator nerve block
Другие имена:
|
|
Плацебо Компаратор: Saline
Saline is injected as a placebo
|
Obturator nerve block with saline(placebo)
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Success rate of successful analgesia, measured with numeric rating scale(NRS) 0-10 with 0=no pain and 10=worst pain. Successful analgesia = NRS<4 at rest and NRS <6 with passive movement of the fractured leg.
Временное ограничение: 30 minutes
|
Success rate of successful analgesia compared between the groups
|
30 minutes
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Median pain score (NRS 0-10)
Временное ограничение: 30 minutes
|
Median pain score 30 minutes after the nerve blocks compared between the groups
|
30 minutes
|
|
Median change in pain score (NRS 0-10)
Временное ограничение: 30 minutes
|
Median change in pain score 30 minutes after the nerve blocks compared between the groups
|
30 minutes
|
|
Course in pain reduction
Временное ограничение: 30 minutes
|
Course in pain reduction during the 30 minutes after the nerve blocks
|
30 minutes
|
|
Time to sufficient analgesia
Временное ограничение: 30 minutes
|
Time from ended injection until sufficient analgesia
|
30 minutes
|
|
Frequency of anesthesia in the skin area of the saphenous nerve
Временное ограничение: 30 minutes
|
Frequency of anesthesia in the skin area innervated by the saphenous nerve
|
30 minutes
|
|
Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
Временное ограничение: 30 minutes
|
Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve
|
30 minutes
|
|
Localization of the worst pain before block
Временное ограничение: 0 minutes
|
Localization of the worst pain before any nerve blocks
|
0 minutes
|
|
Localization of the worst pain after block
Временное ограничение: 30 minutes
|
Localization of the worst pain 30 minutes after the nerve blocks
|
30 minutes
|
|
Discomfort during nerve block procedures (score 0-10, 0=no discomfort)
Временное ограничение: 5 minutes
|
Discomfort during the nerve block procedures compared between procedures
|
5 minutes
|
|
Satisfaction (0-10, 0= very unsatisfactory)
Временное ограничение: 30 minutes
|
Patient satisfaction with the pain treatment
|
30 minutes
|
|
Frequency of ultrasound visualization of femoral nerve
Временное ограничение: 5 minutes
|
Frequency of patients with possible ultrasound visualization af the femoral nerve
|
5 minutes
|
|
Frequency of ultrasound visualization of obturator injection site
Временное ограничение: 5 minutes
|
Frequency of patients with possible ultrasound visualization of the obturator nerve block injection site
|
5 minutes
|
|
Time spend on femoral nerve block
Временное ограничение: 5 minutes
|
Time spend on conducting the femoral nerve block
|
5 minutes
|
|
Time spend on obturator nerve block
Временное ограничение: 5 minutes
|
Time spend on conducting the obturator nerve block
|
5 minutes
|
|
Total morphine equivalent dose of opioid from the time of nerve block to operation
Временное ограничение: Approximately 24 hours in average
|
Total morphine equivalent dose of opioid from the time of nerve block until the time of operation
|
Approximately 24 hours in average
|
|
Total morphine equivalent dose of opioid/time from the time of nerve block to operation
Временное ограничение: Approximately 24 hours in average
|
Total morphine equivalent dose of opioid/time from the time of nerve block until the time of operation
|
Approximately 24 hours in average
|
|
Total morphine equivalent dose of opioid in the first 10 hours after nerve block
Временное ограничение: 10 hours
|
Total morphine equivalent dose of opioid given in the first 10 hours after nerve block
|
10 hours
|
|
Total morphine equivalent dose of opioid/time in the first 10 hours after nerve block
Временное ограничение: 10 hours
|
Total morphine equivalent dose of opioid/time given in the first 10 hours after nerve block
|
10 hours
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Thomas F. Bendtsen, Ph.d., Aarhus University Hospital
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
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
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- protocol2_2tdn
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. .