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临床试验/NCT05097976
NCT05097976招募中4 期

An Oral Methylprednisolone Taper Within a Multimodal Analgesic Regimen After Total Knee Arthroplasty: a Double-Blind Randomized Placebo-Controlled Trial

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2022年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
420
试验地点
2
主要终点
Opioid consumption at one-week postoperative

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of an oral methylprednisolone taper on acute postoperative pain, function, opioid consumption, nausea, and complications following outpatient total knee arthroplasty (TKA). We hypothesize that administration of an oral methylprednisolone taper starting on postoperative day 1 (POD 1) following TKA will be associated with improved pain and decreased opioid use, nausea, and complications at POD1-7, as compared to similar patients who receive placebo. Additionally, those taking methylprednisolone will report decreased pain and greater objective functional outcomes at 3 and 6 weeks postoperatively as compared to controls.

详细描述

Total knee arthroplasty (TKA) has been associated with severe pain in the acute postoperative period. Studies have demonstrated highest pain scores on POD 1 following TKA, however over 50% of patients describe the first two weeks at home as the most painful period of recovery marked by moderate to severe pain. This is an important finding as higher levels of acute pain have been associated with chronic opioid use, disturbed sleep, and impaired early mobilization, which can prolong recovery time and increase rates of adverse events, including venous thromboembolism.

Therefore, extensive research in pain management has been conducted with the purpose of reducing acute postoperative pain. This is of particular interest because over the past two decades average length of hospital stay has decreased while rates of outpatient TKAs with same day discharge has increased. A multimodal pain regimen enables the on-boarding of several medications, including anesthesia and analgesics working at varied pathways to target pain and inflammation, and has proven to be efficacious. This not only decreases patient reported pain scores but is also associated with improved sleep and functional recovery. Despite efficacious multimodal pain regimens, including periarticular injection cocktails, rebound pain in the early postoperative period and medication-induced nausea and vomiting can be problematic.

Corticosteroids are potent anti-inflammatory and pain pathway modulators, and therefore have become an important component of multimodal pain regimens. Corticosteroids have been shown to decrease postoperative levels of inflammatory mediators, such as IL-6 and C-reactive protein. Corticosteroids also block the synthesis of prostaglandins, a nociceptive pain receptor sensitizer and inflammatory mediator that is associated with edema via increased vascular permeability.

The administration of perioperative steroids to mitigate potential impairments in postoperative TKA recovery has been studied extensively in the orthopedic literature. The addition of corticosteroids to multimodal pain regiments, including systemic corticosteroids or perioperative periarticular joint cocktails, has demonstrated improved acute postoperative pain scores function and decreased opioid use without an increase in adverse outcomes, as compared to controls.

Researchers have investigated the effect of additional doses of corticosteroids in the immediate postoperative period. Administration of IV dexamethasone 24 hours postoperatively correlated with lower acute opioid and antiemetic use, and improved pain scores, nausea, length of stay and range of motion, as compared to controls or perioperative corticosteroids alone. The addition of a second postoperative corticosteroid dose, at 24 and 48 hours, have been associated with even greater improvements in pain and function scores, without an increase in complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

Investigator (surgeon) and participant (patient) will be blinded to whether they are discharged with a placebo or treatment (oral corticosteroid).

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient undergoing primary TKA with a diagnosis of osteoarthritis
  • ≥ 18 years old
  • Willingness to undergo randomization

排除标准

  • Reported chronic corticosteroid or opiate use
  • Suspected or confirmed periprosthetic joint infection
  • Revision TKA
  • Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture, or post-traumatic arthritis
  • American Society of Anesthesiologists (ASA) score ≥ 4
  • Reported history of liver disease, renal disease, or diabetes mellitus
  • Current systemic fungal infection or other local infection
  • Immunocompromised or immunosuppressed
  • Current peptic ulcer disease
  • History of hypothyroidism, psychosis, heart failure, myasthenia gravis, ocular herpes simplex virus, or systemic sclerosis
  • Women with reported current pregnancy
  • Known hypersensitivity to methylprednisolone
  • ≤ 18 years old
  • Inability to take oral medications
  • Unable to provide consent

研究组 & 干预措施

Methylprednisolone taper

Experimental

Methylprednisolone taper - 21 x 4mg tablets beginning on POD 1

干预措施: Methylprednisolone (Drug)

Placebo taper

Placebo Comparator

2.Placebo taper - 21 sugar tablets beginning on POD 1 with standard management

干预措施: Placebo (Drug)

结局指标

主要结局

Opioid consumption at one-week postoperative

时间窗: one week

Relative difference in cumulative opioid consumption at Post-op day 7, measured in morphine equivalents.

次要结局

  • Patient reported outcome measures : Daily Visual Analogue Scale for Pain(3 weeks)
  • Clinical outcome: range of motion(6 weeks after treatment)
  • Patient reported outcome measures: knee society score(6 weeks after treatment)
  • Patient reported outcome measures: Daily Visual Analogue Scale for Pain(6 weeks)
  • Patient reported outcome measures: Daily Visual Analogue Scale of nausea(Postoperative days 1 through 7 (week one))
  • Patient reported outcome measures: vomiting episodes(Postoperative days 1 through 7 (week 1))
  • Patient reported outcome measures: hours of sleep(Postoperative days 1 through 7 (week one))
  • Patient reported outcome measures: Daily Visual Analogue Scale for Pain(Week 1)
  • Clinical outcome: range of motion(Preoperatively)
  • Clinical outcome: range of motion(3 weeks after treatment)
  • Patient reported outcome measures: knee society score(Preoperatively)
  • Patient reported outcome measures: knee society score(3 weeks after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Craig J Della Valle, MD

Professor of Orthopedic Surgery, Chief Division of Adult Reconstruction

Rush University Medical Center

研究点 (2)

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