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

NCT07672808 | Not Yet Recruiting

• 1 other identifier: 14751-27
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthroplasty, Replacement, Hip

Keywords

Total hip arthroplasty; Hip replacement; Opioid; Postoperative pain; Multimodal analgesia; Tramadol; Pain management; Opioid reduction; Patient reported outcomes; Orthopedic Surgery

Outcome Measures

Primary Outcomes (6)

• Postoperative Pain Score (Visual Analog Scale)

  Pain severity measured using a visual analog scale (VAS) scored 0-10, where 0 represents no pain and 10 represents the worst possible pain. Scores collected preoperatively, daily during inpatient admission, daily for the first week post-discharge, then weekly for 2 additional weeks via patient pain journal and phone/text check-ins.

  Preoperative baseline through 3 weeks postoperatively

• Postoperative Nausea Score (Visual Analog Scale)

  Nausea severity measured using a visual analog scale (VAS) scored 0-10, where 0 represents no nausea and 10 represents the worst possible nausea. Scores collected preoperatively, daily during inpatient admission, daily for the first week post-discharge, then weekly for 2 additional weeks via patient pain journal and phone/text check-ins.

  Preoperative baseline through 3 weeks postoperatively

• Opioid Consumption

  Total opioid consumption measured in morphine milligram equivalents (MME) and by dose and quantity. Inpatient opioid use collected via electronic medical record and the Michigan Automated Prescription System (MAPS). Post-discharge opioid use recorded by the patient in a postoperative pain journal.

  Three weeks post-op

• Antiemetic Consumption

  Total antiemetic consumption recorded by dose and quantity. Inpatient use collected via electronic medical record; post-discharge use recorded by the patient in a postoperative pain journal.

  three weeks postoperatively

• Length of Hospital Stay

  Total number of days from surgical admission to hospital discharge following primary total hip arthroplasty.

  Perioperative/Periprocedural

• Episodes of Nausea

  Number of nausea episodes documented. Inpatient episodes collected via electronic medical record; post-discharge episodes recorded by the patient in a postoperative pain journal.

  Three weeks postoperatively

Secondary Outcomes (11)

• Hip Injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.)

  Up to three months postoperatively

• Harris Hip Score

  Up to three months postoperatively

• PROMIS Physical Function

  Up to three months postoperatively

• Timed Up and Go Test (TUG)

  Prior to hospital discharge, assessed up to 2 weeks postoperatively

• Range of Motion (ROM)

  up to three months postoperatively

Study Arms (2)

Standard Postoperative Pain Protocol (Control)

ACTIVE COMPARATOR

Participants receive the standard postoperative multimodal pain regimen following primary total hip arthroplasty. All prescriptions, including opioids, are sent directly to the patient's pharmacy per usual care. Participants complete a postoperative pain journal, medication log, respond to phone/text check-ins regarding pain scores, and complete PROMIS, HOOS Jr., and Harris Hip Score questionnaires at follow-up visits postoperatively.

Drug: Standard Multimodal Analgesic Regimen with Opioid Prescription

Opioid-Reduced Postoperative Pain Protocol (Treatment)

EXPERIMENTAL

Participants receive the standard postoperative multimodal pain regimen following primary total hip arthroplasty. Opioid prescriptions (Tramadol) are printed and given to the patient rather than sent directly to the pharmacy, requiring the patient to drive to the pharmacy if they choose to fill them. Participants complete a postoperative pain journal, mediation logs, respond to phone/text check-ins, and complete PROMIS, HOOS Jr., and Harris Hip Score questionnaires at follow-up visits postoperatively.

Behavioral: Opioid-Reduced Multimodal Analgesic Regimen with Printed Prescription

Interventions

Standard Multimodal Analgesic Regimen with Opioid Prescription DRUG

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.

Standard Postoperative Pain Protocol (Control)

Opioid-Reduced Multimodal Analgesic Regimen with Printed Prescription BEHAVIORAL

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 two additional weeks. Opioid consumption is also tracked via the Michigan Automated Prescription System (MAPS).

Opioid-Reduced Postoperative Pain Protocol (Treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Sep 25.

  PMID: 31563269 BACKGROUND

• 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)00582-7.

  PMID: 35717988 BACKGROUND

• Chia PA, Cannesson M, Bui CCM. Opioid free anesthesia: feasible? Curr Opin Anaesthesiol. 2020 Aug;33(4):512-517. doi: 10.1097/ACO.0000000000000878.

  PMID: 32530891 BACKGROUND

• Scully RE, Schoenfeld AJ, Jiang W, Lipsitz S, Chaudhary MA, Learn PA, Koehlmoos T, Haider AH, Nguyen LL. Defining Optimal Length of Opioid Pain Medication Prescription After Common Surgical Procedures. JAMA Surg. 2018 Jan 1;153(1):37-43. doi: 10.1001/jamasurg.2017.3132.

  PMID: 28973092 BACKGROUND

Related Links

• CDC WONDER - Wide-ranging Online Data for Epidemiologic Research. Source for national opioid mortality and epidemiologic data referenced in study background.

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Michael Charters, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio M Pellerito, BA

CONTACT

586-859-3258; ampeller@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Two-arm parallel randomized controlled trial comparing standard postoperative opioid prescription delivery versus printed opioid prescription only following total hip arthroplasty.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)