Optimizing Pain Control in Transurethral Resection of the Prostate
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: Ibuprofen 600 mg, Education.
- Кому может быть актуально
- Состояния в реестре: Pain, BPH With Urinary Obstruction, BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms. Базовые параметры: от 18 лет · Мужчины.
- 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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Обзор
The purpose of this study is to develop a multi-modal protocol for pain management after TURP that minimizes opioid use. The investigators hypothesize this approach will provide non-inferior pain control to the current standard of care which includes opioids as the primary agent. The investigators believe this is an important step in reducing the opioid epidemic in surgical patients.
Подробное описание
In our study, the investigators will randomize TURP patients to standard of care versus a multi-modal protocol. Multi-modal pain control is defined as: "analgesia that combines 2 or more agents that act by different mechanisms to provide analgesia with better pain relief and less opioids". In addition, patients in the intervention arm will receive education regarding pain control and opioid use. The investigators aim to demonstrate non-inferior pain control with this approach. The investigators hope this will inform new guidelines for pain control after TURP, minimize opioid use in this patient population, and educate physicians and patients on providing excellent pain control while minimizing the risks of opioid use. The investigators believe this could ultimately serve as a model for other endoscopic urologic procedures as well.
Вмешательства
- Препарат Ibuprofen 600 mg
We'll be adding ibuprofen while trying to limit oxycodone use while hospitalized. Patients will not be discharged with a narcotic. - Поведенческое Education
We'll be adding education to patient's post-operative instructions to aid in their pain control management.
Первичные конечные точки
- Opioid Consumption [Срок оценки: PACU-72 hours]
- Pain Scores [Срок оценки: PACU-72 hours]
Вторичные конечные точки (3)
- Presence of a foley catheter at discharge. [Срок оценки: 0-48hours]
- Presence of narcotic side effects [Срок оценки: 48 hours after discharge]
- Were there any post-operative complications [Срок оценки: 0-48 hours]
Критерии участия
Критерии включения
- Are identified as candidates for TURP
- Are 18 years of age or greater
- Are proficient in English
Критерии исключения
- Have filled an opioid prescription in the last 2 months
- Have an allergy to a medication included in the protocol
- Have a history of pelvic radiation
- Have renal failure (Serum Cr > 2.0 mg/dl), peptic ulcer disease, history of gastric bypass, cirrhosis, or other contraindication precluding use of NSAID's
- Have liver failure, hepatitis, or alcohol abuse which precludes use of acetaminophen
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
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Virginia Mason Medical Center — Seattle
Публикации
- Alam A, Gomes T, Zheng H, Mamdani MM, Juurlink DN, Bell CM. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. 2012 Mar 12;172(5):425-30. doi: 10.1001/archinternmed.2011.1827. PMID 22412106
- Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298. PMID 27400458
- Hill MV, Stucke RS, McMahon ML, Beeman JL, Barth RJ Jr. An Educational Intervention Decreases Opioid Prescribing After General Surgical Operations. Ann Surg. 2018 Mar;267(3):468-472. doi: 10.1097/SLA.0000000000002198. PMID 28267689
- Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993. PMID 27631771
- Kose O, Saglam HS, Altun ME, Sonbahar T, Kumsar S, Adsan O. Prilocaine irrigation for pain relief after transurethral resection of the prostate. J Endourol. 2013 Jul;27(7):892-5. doi: 10.1089/end.2013.0001. Epub 2013 Jun 12. PMID 23565930
- American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available. PMID 22227789
- Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464. PMID 26977696
- Maughan BC, Hersh EV, Shofer FS, Wanner KJ, Archer E, Carrasco LR, Rhodes KV. Unused opioid analgesics and drug disposal following outpatient dental surgery: A randomized controlled trial. Drug Alcohol Depend. 2016 Nov 1;168:328-334. doi: 10.1016/j.drugalcdep.2016.08.016. Epub 2016 Sep 20. PMID 27663358
Идентификаторы
NCT: NCT04102566 · IRB17-098