Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
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: paracervical block, Lidocaine, ketorolac.
- Кому может быть актуально
- Состояния в реестре: Abnormal Uterine Bleeding, Analgesia, Paracervical Block. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- 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
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy: a Randomized Controlled Trial
Обзор
A randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard lidocaine paracervical block on procedure related pain with office hysteroscopies.
Подробное описание
A randomized double-blind placebo controlled trial comparing the effect of a combined ketorolac and lidocaine paracervical block with a standard lidocaine paracervical block on procedure related pain with office hysteroscopies. Primary Objective: To study the effect of a combined ketorolac and lidocaine paracervical block on procedure related pain with office hysteroscopy. Secondary Objectives: To study the effect of a combined ketorolac and lidocaine paracervical block on patient satisfaction and post procedure pain. To assess for major adverse events with the use of a combined ketorolac and lidocaine paracervical block for office hysteroscopy when compared with a standard lidocaine paracervical block. Primary Endpoint: Pain on a 100 mm visual analogue scale during cervical dilation. Secondary Endpoints: Pain on a 100 mm visual analogue scale during the paracervical block, during the office hysteroscopy, immediately after the hysteroscopy, and 30 minutes after the procedure. Other secondary endpoints include patient satisfaction, frequency of procedure termination, and adverse events. Patients assigned female at birth, booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates. Patients scheduled for office hysteroscopy through seeing a Gynecologist at either 5 E 98th Street Faculty Practice Associates or 1176 5th Avenue Gynecology Practice. 5 E 98th Street primarily cares for privately insured patients, while 1176 5th Avenue cares for a mix of privately insured as well as patients insured with Medicaid. Regardless of recruitment site, all office hysteroscopies will be performed at the 5 E 98th Street facility. A randomized controlled trial designed to investigate if ketorolac added to a paracervical block reduces procedure related pain. Patient will be randomized to a standard paracervical block versus a paracervical block with ketorolac added. The study will be conducted over two years. Patients will be followed for the duration of the two-year study period.
Вмешательства
- Процедура paracervical block
paracervical block with office hysteroscopy - Препарат Lidocaine
Dosage: 20 mL of 1% lidocaine - Препарат ketorolac
Dosage: 2 mL (30 mg) of ketorolac
Первичные конечные точки
- Pain visual analogue scale (VAS) [Срок оценки: during procedure (cervical dilation)]
Вторичные конечные точки (3)
- Pain visual analogue scale (VAS) [Срок оценки: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure]
- Patient Satisfaction [Срок оценки: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure]
- Frequency of procedure termination [Срок оценки: with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure]
Критерии участия
Критерии включения
- Patients assigned female at birth,
- booked for office hysteroscopy at Mount Sinai Hospital faculty practice associates.
Критерии исключения
- Allergy to ketorolac or non-steroidal anti-inflammatory medications
- Allergy to lidocaine
- Presence of thrombocytopenia
- Contraindications to lidocaine
- History of gastritis or gastric ulcer
- Acute renal failure or chronic renal disease
- Chronic liver disease
- History of bleeding diathesis
- Long term narcotic use
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Mount Sinai — New York
Идентификаторы
NCT: NCT06653400 · STUDY-23-01631