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临床试验/NCT04084912
NCT04084912Unknown3 期

The Effect of Preoperative Steroids Injection on Pain and Oedema After Total Knee Arthroplasty . A Double -Blinded Randomized Controlled Study.

Assiut University0 个研究点目标入组 86 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
86
主要终点
Postoperative pain summarized in the first 14 days

研究概览

简要总结

Detect the effect of preoperative steroid injection in total knee arthroplasty on post operative:

  1. pain
  2. oedema
  3. nausea and vomiting
  4. quadriceps power
  5. knee flexion
  6. wound complications

详细描述

Total knee arthroplasty has been identified as one of the most effective surgeries for knee arthritis. Many patients experience moderate to severe pain during the early postoperative period, as the surgery involves extensive bone resection and postsurgical serum levels of cytokine interleukin-6 and C-reactive protein may be elevated.Furthermore, many patients suffer postoperative nausea and vomiting after total knee arthroplasty . The inflammatory response after TKA is pronounced and a result of cumulative effects of anaesthesia and mechanical stress . Inadequate management of postoperative pain is relevant with a series of undesirable effects, including progression to a persistent pain, delayed functional recovery, increased the economic burden and patient dissatisfaction. Steroids may be associated with decreased levels of interleukin-6 and C reactive protein and may, thus, relieve the pain associated with surgery. Dexamethasone is a long-acting glucocorticoid that has been reported to inhibit peripheral phospholipase A, which decreases the pain-aggravating agents from the cyclooxygenase and lipoxygenase pathways . In addition, it reduces postoperative nausea and vomiting by exerting a central antiemetic effect by inhibiting prostaglandin synthesis and the release of endogenous opioids[5] . Some studies also reported potential adverse events, such as infection .

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Any patient scheduled for primary total knee replacement arthroplasty

排除标准

  • Diabetic patients
  • Rheumatoid arthritis patients
  • Patients on regular steroid therapy
  • Patients refused to be enrolled in the study

研究组 & 干预措施

Dexamethasone group

Active Comparator

this group will receive one ampoule Intravenous injection of Dexamethasone Sodium Phosphate 2 ml . 8 mg once by the anesthesiologist immediately before skin incision

干预措施: Dexamethasone Sodium Phosphate (Drug)

Placebo group

Placebo Comparator

this group will receive one ampoule Intravenous injection of Saline once by the anesthesiologist immediately before skin incision

干预措施: Saline Solution (Drug)

结局指标

主要结局

Postoperative pain summarized in the first 14 days

时间窗: 14 days

postoperative pain summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery pain is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no pain and 100 is the worst pain one can imagine Moderate pain is considered a VAS \>30 mm.

次要结局

  • postoperative nausea and vomiting in the first 14 days(14 days)
  • Postoperative Thigh circumference in the first 14 days(14 days)
  • postoperative knee flexion in the first 14 days(14 days)
  • Surgical wound infection in the first 14 days(14 days)

研究者

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

DNKameel

physician

Assiut University

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