Multimodal Analgesic Regimen for Total Hip Arthroplasty: An Initiative to Minimize Postoperative Opioid Use

Обзор

This study examines whether patients undergoing total hip replacement surgery can manage their pain effectively while using fewer opioid pain medications. Participants will be randomly assigned to one of two groups. The first group will receive the standard postoperative pain medication regimen, with all prescriptions sent directly to their pharmacy as usual. The second group will receive the same medications, but their opioid prescription will only be provided as a printed copy rather than being sent directly to the pharmacy, requiring them to choose whether to fill it. All participants will keep a pain journal and complete questionnaires about their medication intake over the first 21 days post-op as well as there function and wellbeing at follow up visits over 3 months. The goal is to determine whether this approach reduces opioid use while still adequately controlling pain after hip replacement surgery.

Вмешательства

• Препарат Standard Multimodal Analgesic Regimen with Opioid Prescription
  Participants receive the standard postoperative multimodal pain regimen following primary total hip arthroplasty. All prescriptions are sent directly to the patient's pharmacy. Opioid consumption tracked via the Michigan Automated Prescription System (MAPS) and patient medication journal. Pain and medication consumption are assessed via daily pain/medication logs daily for the first week, then weekly for two additional weeks.
• Поведенческое Opioid-Reduced Multimodal Analgesic Regimen with Printed Prescription
  Participants receive the standard postoperative multimodal pain regimen following primary total hip arthroplasty. Tramadol is prescribed but the prescription is printed and given to the patient rather than sent to the pharmacy, requiring the patient to actively choose to fill it. This behavioral barrier is designed to reduce opioid consumption while preserving patient autonomy. Pain and medication intake is assessed via daily pain journals and medication logs for the first week, then weekly for

Первичные конечные точки

• Postoperative Pain Score (Visual Analog Scale) [Срок оценки: Preoperative baseline through 3 weeks postoperatively]
• Postoperative Nausea Score (Visual Analog Scale) [Срок оценки: Preoperative baseline through 3 weeks postoperatively]
• Opioid Consumption [Срок оценки: Three weeks post-op]
• Antiemetic Consumption [Срок оценки: three weeks postoperatively]
• Length of Hospital Stay [Срок оценки: Perioperative/Periprocedural]
• Episodes of Nausea [Срок оценки: Three weeks postoperatively]

Вторичные конечные точки (11)

• Hip Injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.) [Срок оценки: Up to three months postoperatively]
• Harris Hip Score [Срок оценки: Up to three months postoperatively]
• PROMIS Physical Function [Срок оценки: Up to three months postoperatively]
• Timed Up and Go Test (TUG) [Срок оценки: Prior to hospital discharge, assessed up to 2 weeks postoperatively]
• Range of Motion (ROM) [Срок оценки: up to three months postoperatively]
• Distance Walked During Physical Therapy Sessions [Срок оценки: Up to three months postoperatively]
• Surgical Site Infection [Срок оценки: Up to three months postoperatively]
• Acute Prosthetic Joint Infection [Срок оценки: Up to three months postoperatively]
• Wound Dehiscence [Срок оценки: Up to three months postoperatively]
• PROMIS Pain Interference [Срок оценки: Up to three months postoperatively]
• PROMIS Emotional Distress: Depression [Срок оценки: Up to three months postoperatively]

Критерии участия

Критерии включения

• Adult patients age 18 and older
• Patients who have undergone total hip arthroplasty by a single, fellowship trained Orthopaedic Surgeon.

Критерии исключения

• Patients with incomplete data in medical records
• Chronic opioid use in the last 3 months
• Ipsilateral joint surgery in the last year
• Cannot tolerate oral medications
• Swallowing difficulties
• Intolerance to Tylenol, Celebrex, Robaxin, Neurontin, or Tramadol
• History of Alcohol abuse
• History of Drug abuse
• History of Renal impairment
• History of Peptic ulcer disease
• History of GI bleeding
• Illicit narcotic usage in past 6 months
• Chronic liver disease
• Chronic pain syndrome

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

• Henry Ford Hospital — Detroit

Публикации

• Pirkle S, Reddy S, Bhattacharjee S, Shi LL, Lee MJ. Chronic Opioid Use Is Associated With Surgical Site Infection After Lumbar Fusion. Spine (Phila Pa 1976). 2020 Jun 15;45(12):837-842. doi: 10.1097/BRS.0000000000003405. PMID 32032322
• Bravo L, Mico JA, Berrocoso E. Discovery and development of tramadol for the treatment of pain. Expert Opin Drug Discov. 2017 Dec;12(12):1281-1291. doi: 10.1080/17460441.2017.1377697. Epub 2017 Sep 17. PMID 28920461
• Beakley BD, Kaye AM, Kaye AD. Tramadol, Pharmacology, Side Effects, and Serotonin Syndrome: A Review. Pain Physician. 2015 Jul-Aug;18(4):395-400. PMID 26218943
• Goldman AH, Griffis CE, Johnson DD, Balazs GC. Shifts in Prescribers' Initial Postoperative Opioid Prescriptions Following Primary Total Hip Arthroplasty Between 2014 and 2018. J Arthroplasty. 2020 Nov;35(11):3208-3213. doi: 10.1016/j.arth.2020.06.002. Epub 2020 Jun 10. PMID 32622716
• Moutzouros V, Jildeh TR, Khalil LS, Schwartz K, Hasan L, Matar RN, Okoroha KR. A Multimodal Protocol to Diminish Pain Following Common Orthopedic Sports Procedures: Can We Eliminate Postoperative Opioids? Arthroscopy. 2020 Aug;36(8):2249-2257. doi: 10.1016/j.arthro.2020.04.018. Epub 2020 Apr 28. PMID 32353620
• Cho CH, Song KS, Min BW, Lee KJ, Ha E, Lee YC, Lee YK. Multimodal approach to postoperative pain control in patients undergoing rotator cuff repair. Knee Surg Sports Traumatol Arthrosc. 2011 Oct;19(10):1744-8. doi: 10.1007/s00167-010-1294-y. Epub 2010 Oct 19. PMID 20957469
• Fiore JF Jr, Olleik G, El-Kefraoui C, Verdolin B, Kouyoumdjian A, Alldrit A, Figueiredo AG, Valanci S, Marquez-GdeV JA, Schulz M, Moldoveanu D, Nguyen-Powanda P, Best G, Banks A, Landry T, Pecorelli N, Baldini G, Feldman LS. Preventing opioid prescription after major surgery: a scoping review of opioid-free analgesia. Br J Anaesth. 2019 Nov;123(5):627-636. doi: 10.1016/j.bja.2019.08.014. Epub 2019 PMID 31563269
• Fiore JF Jr, El-Kefraoui C, Chay MA, Nguyen-Powanda P, Do U, Olleik G, Rajabiyazdi F, Kouyoumdjian A, Derksen A, Landry T, Amar-Zifkin A, Bergeron A, Ramanakumar AV, Martel M, Lee L, Baldini G, Feldman LS. Opioid versus opioid-free analgesia after surgical discharge: a systematic review and meta-analysis of randomised trials. Lancet. 2022 Jun 18;399(10343):2280-2293. doi: 10.1016/S0140-6736(22)005 PMID 35717988

Идентификаторы

NCT: NCT07672808 · 14751-27

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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