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Opioidfri ortopædi

10. november 2026 opdateret af: Eric Wagner, Emory University

Et dobbeltblindet randomiseret kontrolleret forsøg, der undersøger multimodale opioidfrie ortopædiske procedurer

The goal of this investigation is to compare effectiveness of this multimodal regimen at controlling postoperative pain with and without the use of opioid medications.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Prolonged opioid usage after orthopaedic surgery is an important consideration for both the opioid epidemic and postoperative outcomes. The investigators have developed a multimodal pain control regimen designed to decrease or even potentially eliminate the need for opioids after an orthopedic procedure. This is a prospective double blinded randomized controlled trial utilizing a multimodal pain regimen consisting of education and our standard multimodal pain control regimen. Then, the plan is to randomize patients to receive either encapsulated opioids or placebo. The team will assess patient's pain levels, satisfaction, opioid usage, side effects, patient reported outcomes, and complications. This study will serve as a foundation for future opioid-free surgeries and investigations, while helping to identify patients and factors at risk for prolonged opioid usage postoperatively.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

56

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University Hospital
      • Atlanta, Georgia, Forenede Stater, 30029
        • The Emory Clinic
      • Tucker, Georgia, Forenede Stater, 30084
        • Emory Orthopedic and Spine Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Any patient with advanced arthritis undergoing a total joint replacement (e.g. total shoulder arthroplasty, anatomic or reverse), in the primary setting.
  • Any patient undergoing an orthopaedic procedure or surgery of their finger, hand, wrist, forearm, or elbow
  • Any patient undergoing an orthopaedic procedure or surgery for their hip, knee, ankle or foot
  • Patients who have exhausted 3+ months of nonoperative treatment to include activity modifications, optional corticosteroid injections, and physical therapy.
  • Patients over the age of 18 years old that are willing to participate in the study and mentally capable to consent

Exclusion Criteria:

  • Patients with concurrent and significant injuries to other bones or organs, local infections, history of alcohol or medical abuse, preoperative opioid use within 3 months of the surgery, advanced renal or liver disease, contraindication to receiving a nerve block, uncontrolled diabetes mellitus (HbA1C >9.0), or if a prior gastric ulcer precludes Aspirin and anti-inflammatory medications. Prior to inclusion, the patient will undergo blood testing to evaluate both kidney and liver function, including estimated glomerular filtration rate (GFR) as well as alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
  • Workman's compensation status, minors, vulnerable subjects, women who are pregnant, or those who are not willing to consent to participate in the study.
  • Patients who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Opioid Group

Participants will receive encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed after surgery Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain
Medicin: Oxycodone 5 mg Oral Tablet

Encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed
Eksperimentel: Placebo Group

Participants will receive encapsulated placebo tablets x24, to take po q6 hours as need for pain after surgery "Safety" Prescription: Oxycodone5 mg po q6 hours as needed for pain
Medicin: Placebo oral tablet

Encapsulated placebo tablets x24, to take po q6 hours as need for pain

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pain (VAS) Score
Tidsramme: Three times a day postoperatively for the first 2 weeks, then 3 months, 6 months, 12 months, and 24 months postoperative

The investigators will assess patient postoperative pain utilizing a visual analog scale (VAS) for the first 14 days postoperatively. They will also assess pain at each postoperative visit after at 6 weeks, 3 months, 6 months, 12 months and 24 months. This scale will assess pain at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The pain scale will range from 0-10 with 10 being a worse outcome quantifying the highest pain rating.
Three times a day postoperatively for the first 2 weeks, then 3 months, 6 months, 12 months, and 24 months postoperative

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative Opioid Consumption
Tidsramme: Postoperative Days 1-14

Total opioid consumption in Morphine milligram equivalents (MME) during the first 2 weeks after surgery will be measured.
Postoperative Days 1-14
Number of participants that required Rescue Opioid Prescription
Tidsramme: Postoperative Days 1-14

Number of participants that required the prescribed rescue ("safety") opioid prescription during the first 2 postoperative weeks.
Postoperative Days 1-14
Number of tables consumed as Rescue Opioid
Tidsramme: Postoperative Days 1-14

Number of tablets taken from the prescribed rescue ("safety") opioid prescription during the first 2 postoperative weeks.
Postoperative Days 1-14
Number of Additional Opioid Prescription Refills
Tidsramme: Postoperative Days 1-14

Number of additional opioid prescription refills required during the postoperative period.
Postoperative Days 1-14
Number of participants experiencing Postoperative Nausea
Tidsramme: Three times a day postoperatively for the first 2 weeks

Number of participants experiencing nausea during the postoperative period. This scale will assess nausea at 3 different timepoints throughout the day defined as morning, afternoon, and evening. The scale will range from 0-10 with 10 being a worse outcome quantifying the highest nausea rating.
Three times a day postoperatively for the first 2 weeks
Hand/Wrist function Measured by the Single Assessment Numeric Evaluation (SANE)
Tidsramme: Baseline (Preoperative); and at 3, 6, 12, and 24 months postoperatively.

The Single Assessment Numeric Evaluation (SANE) score requires the patient to rate their injured extremity 0-100 as a percentage of their function compared to normal. A rating of 0 is the minimum value and denotes the worse outcome a patient can have on the scale.
Baseline (Preoperative); and at 3, 6, 12, and 24 months postoperatively.
Upper Extremity Function Measured by the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Tidsramme: Baseline (Preoperative); and at 12 and 24 months postoperatively.

Upper extremity disability will be assessed using the QuickDASH questionnaire. Scores range from 0 to 100, with lower scores indicating less disability.
Baseline (Preoperative); and at 12 and 24 months postoperatively.
Overall Satisfaction with the procedure and Pain Management
Tidsramme: 12 and 24 months postoperatively

Overall satisfaction with the surgical procedure and postoperative pain management will be assessed using a patient-reported 5-point rating scale. Participants will select one of the following responses: "Very satisfied", "satisfied", "neutral", "dissatisfied", and "Very dissatisfied".

Responses are assigned a score from 1 to 5, where 1 corresponds to "very dissatisfied" and 5 corresponds to "very satisfied". Higher scores indicate greater satisfaction and better perceived outcomes
12 and 24 months postoperatively
Willingness to undergo the same procedure with the same pain management
Tidsramme: 12 and 24 months postoperatively

Number of Participants that confirm their willingness to undergo the same procedure again using the same postoperative pain management regimen.
12 and 24 months postoperatively
Number of participants Experiencing Major Postoperative Complications
Tidsramme: From surgery through 24 months postoperatively

Number of participants experiencing one or more major postoperative complications, including temporary or permanent nerve injury, hematoma, superficial or deep infection, recurrent moderate or severe pain, fracture, implant loosening, dislocation, or revision surgery.
From surgery through 24 months postoperatively

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Emory University

Efterforskere

  • Ledende efterforsker: Eric Wagner, MD, Emory University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. december 2020

Primær færdiggørelse (Faktiske)

20. juli 2026

Studieafslutning (Faktiske)

20. juli 2026

Datoer for studieregistrering

Først indsendt

30. november 2020

Først indsendt, der opfyldte QC-kriterier

7. december 2020

Først opslået (Faktiske)

9. december 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00000478

Plan for individuelle deltagerdata (IPD)

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