Femoral and Sciatic Nerve Blocks Added to Obturator Nerve Block for Prevention of Obturator Reflex
Comparison of the Efficacy of Femoral and Sciatic Nerve Blocks Added to Obturator Nerve Block in Preventing the Obturator Reflex
This prospective, randomized controlled study aims to evaluate whether adding femoral and sciatic nerve blocks to obturator nerve block improves the prevention of obturator reflex during transurethral resection of bladder tumors under spinal anesthesia.
Ninety patients will be randomly assigned to three groups: obturator nerve block alone, obturator plus femoral nerve blocks, or obturator plus femoral and sciatic nerve blocks. Adductor muscle contractions, surgeon satisfaction, procedure duration, and complications will be evaluated.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This single-center, prospective, randomized controlled study will include 90 patients aged 18-90 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for transurethral resection of unilateral lateral bladder wall tumors under spinal anesthesia.
Eligible patients will be randomly allocated into three groups of 30 patients each:
Group 1: Obturator nerve block (ONB) alone.
Group 2: Obturator nerve block combined with femoral nerve block (ONB + FNB).
Group 3: Obturator nerve block combined with femoral and sciatic nerve blocks (ONB + FNB + SNB).
The nerve blocks will be performed using ultrasound guidance according to the study protocol.
During surgery, the occurrence and severity of adductor muscle contractions associated with the obturator reflex will be recorded. Contractions will be classified as absent, mild, or severe according to their interference with the surgical procedure. The total number of contractions will also be documented.
Additional assessments will include block procedure duration, surgical duration, surgeon satisfaction using a 0-10 numerical scale, conversion to general anesthesia, bleeding, bladder injury, perforation, blood transfusion, and complications related to the nerve blocks.
The study aims to determine whether adding femoral and sciatic nerve blocks to obturator nerve block improves the prevention of obturator reflex during transurethral bladder tumor resection.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Tuna Ertürk, MD
- Номер телефона: +905325010066
- Электронная почта: tunaerturk22@yahoo.com
Места учебы
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Istanbul, Турция (Туркие), 34668
- Sultan 2. Abdulhamid Han Training and Research Hospital
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Контакт:
- Hakan EMİRKADI, MD
- Номер телефона: +905322609367
- Электронная почта: hemirkadi@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Patients aged 18-90 years.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Patients scheduled for transurethral resection of unilateral lateral or inferolateral bladder wall tumors under spinal anesthesia.
- Patients providing informed consent personally or through a legally authorized representative.
- No known hypersensitivity to the medications used in the study.
- No infection or anatomical deformity at the nerve block sites.
- No antithrombotic treatment and normal coagulation parameters.
Exclusion Criteria:
- Age younger than 18 or older than 90 years.
- ASA physical status IV or higher.
- Absence of informed consent.
- Hypersensitivity to the study medications or their components.
- Infection or anatomical deformity at the nerve block sites.
- Antithrombotic treatment.
- Abnormal coagulation parameters.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Obturator Nerve Block (ONB)
Patients will receive an ultrasound-guided obturator nerve block. |
Ultrasound-guided obturator nerve block will be performed. |
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Экспериментальный: ONB + FNB
Patients will receive ultrasound-guided obturator and femoral nerve blocks. |
Ultrasound-guided obturator nerve block will be performed. Ultrasound-guided femoral nerve block will be performed in addition to obturator nerve block. |
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Экспериментальный: ONB + FNB + SNB
Patients will receive ultrasound-guided obturator, femoral, and sciatic nerve blocks. |
Ultrasound-guided obturator nerve block will be performed. Ultrasound-guided femoral nerve block will be performed in addition to obturator nerve block. Ultrasound-guided sciatic nerve block will be performed in addition to obturator and femoral nerve blocks. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of Participants With at Least One Intraoperative Adductor Muscle Contraction
Временное ограничение: On the day of surgery, during transurethral tumor resection
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Participants experiencing at least one adductor muscle contraction during transurethral bladder tumor resection will be recorded. The number and proportion of affected participants will be compared across the three groups. |
On the day of surgery, during transurethral tumor resection
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of Participants With Severe Intraoperative Adductor Muscle Contractions
Временное ограничение: On the day of surgery, during transurethral tumor resection
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Adductor muscle contractions will be classified as severe if they interfere with the surgeon during resection. The number of participants experiencing at least one severe contraction will be recorded and compared across the three groups. |
On the day of surgery, during transurethral tumor resection
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Surgeon Satisfaction Score
Временное ограничение: At the end of surgery, on the day of the procedure
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Surgeon satisfaction will be assessed using a numerical rating scale from 0 (very poor) to 10 (excellent). Scores will be compared across the three groups. |
At the end of surgery, on the day of the procedure
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Total Number of Intraoperative Adductor Muscle Contractions
Временное ограничение: On the day of surgery, during transurethral tumor resection
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The total number of adductor muscle contractions occurring during transurethral bladder tumor resection will be recorded for each participant and compared across the three groups. |
On the day of surgery, during transurethral tumor resection
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Number of Participants With Bladder Wall Injury or Perforation
Временное ограничение: On the day of surgery, during transurethral tumor resection
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The occurrence of bladder wall injury or perforation during transurethral bladder tumor resection will be recorded and compared across the three groups. |
On the day of surgery, during transurethral tumor resection
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Number of Participants With Inability to Continue Surgery Due to Adductor Muscle Contraction
Временное ограничение: On the day of surgery, during transurethral tumor resection
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Inability to continue surgical resection due to intraoperative adductor muscle contraction will be recorded and compared across the three groups. |
On the day of surgery, during transurethral tumor resection
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Tuna Ertürk, MD, University of Health Sciences Sultan 2. Abdulhamid Han Training and Research Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 20-115
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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