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

22 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Michigan
      • Detroit, Michigan, Verenigde Staten, 48202
        • Henry Ford Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Geneesmiddel: 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.
Experimenteel: 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.
Gedragsmatig: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative Pain Score (Visual Analog Scale)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Perioperative/Periprocedural
Total number of days from surgical admission to hospital discharge following primary total hip arthroplasty.
Perioperative/Periprocedural
Episodes of Nausea
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hip Injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Henry Ford Health System

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

30 mei 2027

Studieregistratiedata

Eerst ingediend

5 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 juni 2026

Eerst geplaatst (Werkelijk)

29 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

22 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 14751-27

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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