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

22. Juni 2026 aktualisiert von: Michael Charters, MD, Henry Ford Health System
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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Michigan
      • Detroit, Michigan, Vereinigte Staaten, 48202
        • Henry Ford Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Standard Postoperative Pain Protocol (Control)
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.
Arzneimittel: 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.
Experimental: Opioid-Reduced Postoperative Pain Protocol (Treatment)
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.
Verhalten: 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 two additional weeks. Opioid consumption is also tracked via the Michigan Automated Prescription System (MAPS).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Postoperative Pain Score (Visual Analog Scale)
Zeitfenster: Preoperative baseline through 3 weeks postoperatively
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)
Zeitfenster: Preoperative baseline through 3 weeks postoperatively
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
Zeitfenster: Three weeks post-op
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
Zeitfenster: three weeks postoperatively
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
Zeitfenster: Perioperative/Periprocedural
Total number of days from surgical admission to hospital discharge following primary total hip arthroplasty.
Perioperative/Periprocedural
Episodes of Nausea
Zeitfenster: Three weeks postoperatively
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hip Injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.)
Zeitfenster: Up to three months postoperatively
Patient-reported outcome measure assessing hip pain and function specific to joint replacement patients. Scored on a 0-100 scale, with higher scores indicating better hip function. Administered at scheduled postoperative follow-up visits.
Up to three months postoperatively
Harris Hip Score
Zeitfenster: Up to three months postoperatively
Clinician-administered outcome measure assessing hip pain, function, absence of deformity, and range of motion following total hip arthroplasty. Scored on a scale of 0 to 100, where higher scores indicate better hip function and outcomes.
Up to three months postoperatively
PROMIS Physical Function
Zeitfenster: Up to three months postoperatively
Patient-reported outcome measure assessing self-reported capability to perform physical activities. Administered via the PROMIS Physical Function item bank at scheduled postoperative follow-up visits. Scores are reported as T-scores with a mean of 50 and standard deviation of 10 in the general population, where higher scores indicate better physical function.
Up to three months postoperatively
Timed Up and Go Test (TUG)
Zeitfenster: Prior to hospital discharge, assessed up to 2 weeks postoperatively
Functional mobility test measuring the time in seconds for a patient to rise from a chair, walk 3 meters, turn, walk back, and sit down. Administered by physical therapy prior to hospital discharge
Prior to hospital discharge, assessed up to 2 weeks postoperatively
Range of Motion (ROM)
Zeitfenster: up to three months postoperatively
Hip range of motion measured in degrees at postoperative follow-up visits by the treating surgeon or clinical staff.
up to three months postoperatively
Distance Walked During Physical Therapy Sessions
Zeitfenster: Up to three months postoperatively
Total distance walked in feet or meters recorded by physical therapy during inpatient physical therapy sessions following surgery.
Up to three months postoperatively
Surgical Site Infection
Zeitfenster: Up to three months postoperatively
Occurrence of superficial or deep surgical site infection at the operative site following primary total hip arthroplasty, identified during clinical follow-up visits or by chart review.
Up to three months postoperatively
Acute Prosthetic Joint Infection
Zeitfenster: Up to three months postoperatively
Occurrence of acute periprosthetic joint infection following primary total hip arthroplasty, identified during clinical follow-up visits or by chart review per standard clinical criteria.
Up to three months postoperatively
Wound Dehiscence
Zeitfenster: Up to three months postoperatively
Occurrence of wound dehiscence at the surgical site following primary total hip arthroplasty, identified during clinical follow-up visits or by chart review.
Up to three months postoperatively
PROMIS Pain Interference
Zeitfenster: Up to three months postoperatively
Patient-reported outcome measure assessing the degree to which pain interferes with daily activities and social participation. Administered via the PROMIS Pain Interference item bank at scheduled postoperative follow-up visits. Scores are reported as T-scores with a mean of 50 and standard deviation of 10 in the general population, where higher scores indicate greater pain interference.
Up to three months postoperatively
PROMIS Emotional Distress: Depression
Zeitfenster: Up to three months postoperatively
Patient-reported outcome measure assessing depressive symptoms including helplessness, hopelessness, and emotional exhaustion. Administered via the PROMIS Emotional Distress. Depression item bank at scheduled postoperative follow-up visits. Scores are reported as T-scores with a mean of 50 and standard deviation of 10 in the general population, where higher scores indicate greater emotional distress.
Up to three months postoperatively

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Henry Ford Health System

Ermittler

  • Hauptermittler: Michael Charters, MD, Henry Ford Health System

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

30. Mai 2027

Studienanmeldedaten

Zuerst eingereicht

5. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juni 2026

Zuerst gepostet (Tatsächlich)

29. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 14751-27

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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