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Набор скоро начнётся NCT07664956

Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy

Фаза IV С лечением Minimally Invasive Surgical Procedures Abnormal Uterine Bleeding, Unspecified Adenomyosis of Uterus Fibroid Uterus

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: Cyclobenzaprine.
Кому может быть актуально
Состояния в реестре: Minimally Invasive Surgical Procedures, Abnormal Uterine Bleeding, Unspecified, Adenomyosis of Uterus, Fibroid Uterus. 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

Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy: A Randomized Controlled Trial

Обзор

Typical postoperative pain control after minimally invasive hysterectomy includes ibuprofen, acetaminophen, and a short course of narcotics. The purpose of this study is to see if adding cyclobenzaprine to this regime improves pain control and lessens narcotic use.

Подробное описание

The purpose of this study is to gather more information on cyclobenzaprine as part of postoperative pain control. Cyclobenzaprine, aka Flexeril®, is NOT an experimental drug and is already approved by the Food and Drug Administration (FDA) for acute, painful muscle spasms. It is commonly used for muscle-related pain disorders.

This research is being done because prior studies have shown that cyclobenzaprine helps with pain due to muscle spasms. Some studies showed that cyclobenzaprine does help reduce pain scores in patients undergoing abdominal or joint surgery, but the studies are very limited. This study will see if cyclobenzaprine can be used to decrease post-operative pain in patients undergoing minimally invasive hysterectomy.

Вмешательства

  • Препарат Cyclobenzaprine
    5mg cyclobenzaprine q8hr for one week postoperatively after minimally invasive hysterectomy

Первичные конечные точки

  • Visual Analog Scale (VAS) Pain Score on Post Op Day 3 [Срок оценки: 3 days postoperatively]
Вторичные конечные точки (4)
  • Visual Analog Scale (VAS) Pain Scores on POD 0, 1, and 7 [Срок оценки: 1 week]
  • Cyclobenzaprine Side Effects as Part of Multimodal Analgesia [Срок оценки: 1 week]
  • Potential Contributors to Differences in Visual Analog Pain Scale Reported [Срок оценки: 1 week]
  • Number of Alternative Postoperative Pain Medications Required to Achieve Adequate Analgesia [Срок оценки: 1 week]

Критерии участия

Критерии включения

  • Age >18yo
  • Female
  • English speaking
  • Undergoing (robotic assisted or classic) total laparoscopic hysterectomy ± unilateral or bilateral salpingectomy ± unilateral or bilateral oophorectomy
  • If other procedures such as lysis of adhesions, excision of endometriosis, or ureterolysis are indicated based on intraoperative evaluation, those patients may still be included
  • Surgery took place at ChristianaCare Hospitals
  • No allergies or contraindications to standard of care post operative pain medications (acetaminophen, NSAIDs, narcotics) or cyclobenzaprine

Критерии исключения

  • Age <18yo
  • Male
  • Pregnant, breastfeeding
  • Non-English speaking
  • Primary procedures other than laparoscopic hysterectomy
  • Laparoscopic myomectomy
  • Laparoscopic resection of endometriosis
  • Laparoscopic unilateral or bilateral salpingectomy ± unilateral or bilateral oophorectomy ± unilateral or bilateral cystectomy without hysterectomy
  • Hysteroscopic procedures
  • Bartholin gland marsupialization
  • Operations that are scheduled as or converted to the open approach
  • Procedures with planned or unplanned bladder or bowel surgery
  • Allergies or contraindications to standard post operative pain control medications (acetaminophen, NSAIDs, narcotics), such as kidney or liver damage/failure, bariatric surgery, history of gastric ulcer, etc.
  • Chronic pain issues, whether self-diagnosed or by a physician, currently undergoing management
  • Currently undergoing medication assisted treatment for opioid use disorder
  • Currently using opioids consistently
  • Allergies or contraindications to cyclobenzaprine:
  • Absolute: use of MAO inhibitors within 14 days, recent heart attack, congestive heart failure, heart block or other conduction abnormalities, cardiac arrhythmias, hyperthyroidism, history of serotonin syndrome
  • Allergies or contraindications to inactive ingredients in Flexeril, such as lactose
  • Patient's receiving gabapentin at baseline or postoperatively, due to potential sedating effects, or other sedating drugs such as scheduled benzodiazepines and barbiturates

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
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • ChristianaCare Health System — Newark

Публикации

  • Khan NF, Bykov K, Barnett ML, Glynn RJ, Vine SM, Gagne JJ. Comparative Risk of Opioid Overdose With Concomitant Use of Prescription Opioids and Skeletal Muscle Relaxants. Neurology. 2022 Sep 27;99(13):e1432-e1442. doi: 10.1212/WNL.0000000000200904. Epub 2022 Jul 14. PMID 35835561
  • Chen C, Hennessy S, Brensinger CM, Miano TA, Bilker WB, Dublin S, Chung SP, Horn JR, Tiwari A, Leonard CE. Comparative Risk of Injury with Concurrent Use of Opioids and Skeletal Muscle Relaxants. Clin Pharmacol Ther. 2024 Jul;116(1):117-127. doi: 10.1002/cpt.3248. Epub 2024 Mar 14. PMID 38482733
  • Day LT, Jeanmonod RK. Serotonin syndrome in a patient taking Lexapro and Flexeril: a case report. Am J Emerg Med. 2008 Nov;26(9):1069.e1-3. doi: 10.1016/j.ajem.2008.03.028. PMID 19091289
  • Braschi E, Garrison S, Allan GM. Cyclobenzaprine for acute back pain. Can Fam Physician. 2015 Dec;61(12):1074. No abstract available. PMID 26668287
  • Tu J, Zhang C, Xie S, He J, Zhang H. Cyclobenzaprine-related adverse events: a comprehensive pharmacovigilance analysis using the FDA Adverse Event Reporting System. Front Med (Lausanne). 2025 Sep 22;12:1574395. doi: 10.3389/fmed.2025.1574395. eCollection 2025. PMID 41058614
  • Choi JB, Kang K, Song MK, Seok S, Kim YH, Kim JE. Pain Characteristics after Total Laparoscopic Hysterectomy. Int J Med Sci. 2016 Jul 5;13(8):562-8. doi: 10.7150/ijms.15875. eCollection 2016. PMID 27499688
  • Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available. PMID 26757238
  • Turner NF, Greco NJ. The rapid recovery study: Cyclobenzaprine's effect on recovery following joint arthroplasty. J Orthop. 2024 Mar 13;54:81-85. doi: 10.1016/j.jor.2024.03.016. eCollection 2024 Aug. PMID 38550387

Идентификаторы

NCT: NCT07664956 · 50092

Первоисточники (государственные реестры)

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