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

Overview

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.

Interventions

• Drug 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.
• Behavioral 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

Primary outcome measures

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

Secondary outcome measures (11)

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Henry Ford Hospital — Detroit

Publications

• 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

Identifiers

NCT: NCT07672808 · 14751-27

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗