Hip Arthroscopy Postoperative Opioid Demands
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: Control Group Regimen, Opioid reduced regimen.
- Кому может быть актуально
- Состояния в реестре: Opioid Use, Pain, Femoral Acetabular Impingement, Labral Tear, Glenoid. Базовые параметры: 18 лет — 80 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
- 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
Randomized Control Trial Evaluating Postoperative Opioid Demands Following Hip Arthroscopy
Обзор
This study will be a prospective, single-blinded, randomized controlled trial (RCT), investigating the influence of the number of opioid pills prescribed following primary hip arthroscopy. All patients who sign the consent form will be enrolled in the suited and randomized to one of the two treatment arms. The intervention group will receive 5 Norco pills, gabapentin (30 mg, once daily for 10 days following surgery), and Tylenol (1000 mg, three times daily for 10 days following surgery) while the control will receive the standard at our practice of 30 Norco pills.
Подробное описание
Follow-up will take place at 1, 3, 6, and 12 months postoperatively. Variables of interest will include postoperative patient pain scores (i.e. Visual Analog Scale or VAS), total morphine equivalents taken in the first 30 days after discharge, number of unused opioid pills, opioid disposal rates, and standard patient reported outcomes measures (PROMs) including hip disability and osteoarthritis outcome score (HOOS), Harris Hip score (HHS), VAS for pain, international hip outcome tool (iHOT-12), and Hip outcome score (HOS).
For the purpose of this study, the investigators propose two standardized prescribing patterns across all teams. The first would be the control postoperative prescribing pattern and the second would be the experimental opioid reduced prescribing pattern. Patients will not be informed if their postoperative prescriptions are part of the control or opioid reduced prescribing pattern. Of note, patients will be allowed to cross over from the opioid reduced experimental group to the standard of care control group if they have breakthrough pain following surgery.
Timeline of Events:
1. Following informed consent during the office visit when surgery is scheduled, all patients will be randomized to one of the postoperative pain management protocols, either the control or opioid reduced. 2. Subjects will proceed with hip arthroscopy, including appropriate treatment and documentation of concomitant injuries. 3. Over the course of the 1st month postoperatively, patients will complete a 30-day diary detailing which medications they took on each day and their daily average pain level (indicating whether physical therapy was performed). Data pertaining to prescription refills (I.e., number of refills, time to refill), number of left over pain medications, and disposal rates of opioid medications will also be recorded at these time points as well. 4. Patients will return for standard of care postoperative visits at 1, 3, 6, and 12 months postoperatively. Patients will be asked to complete PROM questionnaires at the 3, 6, and 12 month follow-up time points
Вмешательства
- Другое Control Group Regimen
Norco (hydrocodone-acetaminophen) 5mg-325mg, 30 total pills. This is the standard of care prescribing procedure for pain management after hip arthroscopy. - Другое Opioid reduced regimen
Tylenol extra strength (1000 mg, three times daily for 10 days following surgery), Gabapentin (300 mg at night for 10 days following surgery) and Norco (hydrocodone-acetaminophen) 5mg-325mg, 5 total pills
Первичные конечные точки
- Pain Score [Срок оценки: 1 month postoperatively]
- Pain Score [Срок оценки: 3 months postoperatively]
- Pain Score [Срок оценки: 6 months postoperatively]
- Pain Score [Срок оценки: 12 months postoperatively]
- Total morphine equivalents taken [Срок оценки: In the first 30 days after discharge]
- Number of unused opioid pills [Срок оценки: In the first 30 days after discharge]
- Opioid disposal rates [Срок оценки: In the first 30 days after discharge]
Вторичные конечные точки (12)
- Hip disability and osteoarthritis outcome score [Срок оценки: 1 month postoperatively]
- Hip disability and osteoarthritis outcome score [Срок оценки: 3 months postoperatively]
- Hip disability and osteoarthritis outcome score [Срок оценки: 6 months postoperatively]
- Hip disability and osteoarthritis outcome score [Срок оценки: 12 months postoperatively]
- Harris Hip score [Срок оценки: 1 month postoperatively]
- Harris Hip score [Срок оценки: 3 months postoperatively]
- Harris Hip score [Срок оценки: 6 months postoperatively]
- Harris Hip score [Срок оценки: 12 months postoperatively]
- International hip outcome tool [Срок оценки: 1 month postoperatively]
- International hip outcome tool [Срок оценки: 3 months postoperatively]
- International hip outcome tool [Срок оценки: 6 months postoperatively]
- International hip outcome tool [Срок оценки: 12 months postoperatively]
Критерии участия
Критерии включения
- Adult patients age 18-80 years
- English speaking
- Opioid naive patient (defined as not taking opioid pills within 6 weeks prior to surgery), confirmed by checking the Illinois Prescription monitoring program
- Primary hip arthroscopy
- Written and informed consent for study participation
Критерии исключения
- Minors (<18 years of age)
- Opioid tolerant patients
- Revision surgery
- Prior infections of the operative joint
- History of active malignancy within the past 5 years
- Chronic pain conditions including low back pain, chronic pain syndrome, fibromyalgia
- History of alcohol or other substance use disorder
- Other disease states including rheumatologic conditions, diabetes mellitus, hypo/hyperthyroidism, depression, anxiety
- Grade IV chondral defects
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
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Rush University Medical Center — Chicago
Идентификаторы
NCT: NCT04094701 · 19071807