The Effect of Preoperative Steroids Injection on Pain and Oedema After Total Knee Arthroplasty . A Double -Blinded Randomized Controlled Study.
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:
- pain
- oedema
- nausea and vomiting
- quadriceps power
- knee flexion
- 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
- 是
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
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
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)
