Preemptive Anti-Inflammatory Use of Celecoxib in Knee Arthroplasty Surgery: a Double Blinded, Placebo-Controlled Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Compare total pain rating in group receiving 7day celecoxib against in 1 dose celecoxib
研究概览
简要总结
This double blinded, placebo controlled, study seeks to determine the efficacy of preoperative anti-inflammatory therapy on the reduction of postoperative pain in knee arthroplasty surgery. Pre-emptive use of NSAIDS has demonstrated only modest reduction in post-operative pain in previous studies. However, the short duration of dosing in those studies did not capitalized on the anti-inflammatory properties of NSAIDS. Short-term use of NSAIDS only provides pain relief and does not address inflammation. Traditional NSAIDS cannot be used preoperatively due to platelet effects. Celecoxib, however, is both an analgesic and anti-inflammatory, but does not interfere with bleeding. It can therefore be safely used before surgery. This study hypothesizes that the use of celecoxib for seven days preoperatively reduces postoperative inflammation and consequently pain. A detailed Medline search has not identified any studies into the preoperative use of an NSAID at a dosing level that achieves anti-inflammatory effects.If effective in reducing postoperative pain, this research could lead to a new understanding of the role inflammation plays in orthopedic procedures and other elective procedures and thus improve patient outcomes in the future.
详细描述
Abstract:
This double blinded, placebo controlled, study seeks to determine the efficacy of preoperative anti-inflammatory therapy on the reduction of postoperative pain in knee arthroplasty surgery. Pre-emptive use of NSAIDS has demonstrated only modest reduction in post-operative pain in previous studies. However, the short duration of dosing in those studies did not capitalized on the anti-inflammatory properties of NSAIDS. Short-term use of NSAIDS only provides pain relief and does not address inflammation. Traditional NSAIDS cannot be used preoperatively due to platelet effects. Celecoxib, however, is both an analgesic and anti-inflammatory, but does not interfere with bleeding. It can therefore be safely used before surgery. This study hypothesizes that the use of celecoxib for seven days preoperatively reduces postoperative inflammation and consequently pain. A detailed Medline search has not identified any studies into the preoperative use of an NSAID at a dosing level that achieves anti-inflammatory effects.If effective in reducing postoperative pain, this research could lead to a new understanding of the role inflammation plays in orthopedic procedures and other elective procedures and thus improve patient outcomes in the future.
Purpose and Significance:
It is commonly accepted that inflammation significantly increases pain. To date, no study has examined the potential benefits of preemptively treating inflammation before surgery. While the analgesic effects of NSAIDs have a rapid onset, the maximal anti-inflammatory effect can take one to three weeks to be realized. Due to bleeding concerns, traditional NSAIDS such as naprosyn or ibuprofen cannot, and have not, been used preoperatively. Following surgery, the inflammatory cascade of cells and chemical mediators inundates the surgical wound and creates acute inflammation. Once this has happened NSAIDs have missed the opportunity to treat this acute inflammation. Post-operative and single dose preoperative use of NSAIDs act exclusively as analgesics. Since celecoxib has no impact on postoperative bleeding, it can be safely administered preoperatively. With adequate time before an elective operation, one has the opportunity to reach steady state pharmacokinetics and a sufficient serum level to prevent inflammation -- and therefore pain
Aims of Study:
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
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients undergoing knee arthroplasty
排除标准
- •Subjects will be excluded from the study for the following reasons:
- •Allergy to non-steroidal anti-inflammatory medications
- •Subjects must not be taking another NSAID while the study is conducted
- •Bleeding disorder
- •Impaired renal function (serum creatinine >1.2 x upper limit of normal)
- •Liver Disease (SGPT(ALT) or SGOT(AST) > 1.5x upper limit of normal)
- •Heart Disease
- •Taking an ACE inhibitor
- •Taking a diuretic
- •Must not be taking an NSAID on a daily basis during the study period
- •Pregnant or planning to start a pregnancy soon
结局指标
主要结局
Compare total pain rating in group receiving 7day celecoxib against in 1 dose celecoxib
次要结局
- 1. Comparison of pain rating VRS "When you woke up following surgery," and at 24 hours and 48 hours postoperatively in the two study groups
- Comparison of patient reported maximum pain on VRS in the study groups.
