Nitroglycerin Ointment for Pain Relief After Endoscopic Hemorrhoid Band Ligation
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: Nitroglycerin Ointment, Placebo Ointment.
- Кому может быть актуально
- Состояния в реестре: Internal Hemorrhoids, Postoperative Pain After Endoscopic Rubber Band Ligation. Базовые параметры: 18 лет — 75 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Randomized, Double-Blind, Placebo-Controlled Study of Nitroglycerin Ointment for Postoperative Pain Relief After Endoscopic Rubber Band Ligation of Internal Hemorrhoids
Обзор
This study is designed to evaluate whether nitroglycerin ointment can reduce pain after endoscopic rubber band ligation for internal hemorrhoids. Endoscopic rubber band ligation is a commonly used, minimally invasive treatment for internal hemorrhoids, but postoperative anal pain is a frequent and sometimes severe complication that can affect daily activities and recovery. Participants undergoing endoscopic rubber band ligation will be randomly assigned to receive either nitroglycerin ointment or a placebo ointment applied locally after the procedure. Both participants and investigators will be blinded to the treatment assignment. All participants will receive the same standard perioperative care, and rescue pain medication will be provided when necessary. The primary goal of the study is to compare the proportion of patients who require rescue pain medication within 72 hours after the procedure between the two groups. Secondary outcomes include pain intensity at multiple time points, time to complete pain relief, postoperative complications, treatment-related adverse events, and overall treatment effectiveness at 30 days. The results of this study may help identify a safe and effective option for improving pain control after endoscopic treatment of internal hemorrhoids.
Вмешательства
- Препарат Nitroglycerin Ointment
Nitroglycerin ointment will be applied locally to the intrarectal wound area after endoscopic rubber band ligation for internal hemorrhoids. Treatment will begin immediately after the procedure. Participants will apply approximately 1-1.5 cm of ointment three times daily for a total duration of 2 weeks, in addition to standard perioperative management. Rescue analgesia with oral loxoprofen sodium will be permitted according to the predefined protocol when clinically indicated. - Препарат Placebo Ointment
A placebo ointment identical in appearance and packaging to the study drug will be applied locally to the intrarectal wound area after endoscopic rubber band ligation for internal hemorrhoids. Treatment will begin immediately after the procedure. Participants will apply approximately 1-1.5 cm of ointment three times daily for a total duration of 2 weeks, in addition to standard perioperative management. Rescue analgesia with oral loxoprofen sodium will be permitted according to the predefined pr
Первичные конечные точки
- Use of Rescue Analgesic Medication Within 72 Hours After Procedure [Срок оценки: 0 to 72 hours after endoscopic rubber band ligation]
Критерии участия
Критерии включения
- Age: 18 to 75 years, male or female
- Diagnosis/indication: Internal hemorrhoids grade I, II, or III scheduled for endoscopic rubber band ligation
- Consent: Able and willing to participate and provide written informed consent
Критерии исключения
- Compliance/assessment: Unable to understand study endpoints or complete study records/forms
- Concomitant medications: Current use of oral nitrates or calcium channel blockers
- Allergy: Known allergy to lactulose oral solution, nitroglycerin ointment, or other study-related medications
- Pregnancy/lactation: Pregnant or breastfeeding women
- Procedure tolerance: Unable to tolerate hemorrhoid band ligation, colonoscopy, or bowel preparation
- Severe comorbidities: Severe cardiac, respiratory, neurologic, or psychiatric disorders
- Legal capacity: Lacking legal capacity for civil conduct or lacking insight/judgment to provide valid consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07391501 · NYSZYYEC2026K010R001