Ortopedie bez opioidů
Dvojitě zaslepená randomizovaná kontrolovaná studie zkoumající multimodální ortopedické postupy bez opioidů
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
-
-
Georgia
-
Atlanta, Georgia, Spojené státy, 30322
- Emory University Hospital
-
Atlanta, Georgia, Spojené státy, 30029
- The Emory Clinic
-
Tucker, Georgia, Spojené státy, 30084
- Emory Orthopedic and Spine Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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 |
Encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed |
|
Experimentální: 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 |
Encapsulated placebo tablets x24, to take po q6 hours as need for pain |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Pain (VAS) Score
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Postoperative Opioid Consumption
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Eric Wagner, MD, Emory University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Neurologické projevy
- Nemoci nervového systému
- Pooperační komplikace
- Patologické procesy
- Neurobehaviorální projevy
- Poruchy vnímání
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Bolest
- Bolest, pooperační
- Agnosia
- Heterocyklické sloučeniny
- Heterocyklické sloučeniny, fúzované kroužek
- Farmaceutické přípravky
- Formy dávkování
- Alkaloidy
- Polycyklické aromatické uhlovodíky
- Polycyklické sloučeniny
- Heterocyklické sloučeniny, 4 nebo více prstenů
- Morfináni
- Alkaloidy opiátů
- Heterocyklické sloučeniny, přemostěný prsten
- Fenanthrenes
- Morfinové deriváty
- Kodein
- Oxykodon
- Tablety
Další identifikační čísla studie
- STUDY00000478
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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