COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Postoperative VAS score at rest 24 hours after surgery
研究概览
简要总结
Recent studies on molar surgery have shown that a combination of a glucocorticoid and NSAID or COX-2 selective inhibitor gives better pain relief than either of the drugs used separately. The investigators group has also shown that adding dexamethasone on top of a regimen of paracetamol, NSAID and local anesthesia resulted in 45% painfree patients at rest after ambulatory breast cancer surgery.
The goal of this study is to test the NSAID + glucocorticoid concept in ACl repair. The investigators want to evaluate whether a selective COX-2 selective inhibitor or a glucocorticoid or a combination of both drugs, as part of a multimodal analgesic regime, can provide improved pain relief and shorter hospital stay in patients undergoing outpatient ACL surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arthroscopic reconstruction of the anterior crucial ligament (ACL)
- •At least 18 years old
- •ASA I + II
排除标准
- •Known renal impairment
- •Liver failure and/-or an asthmatic condition
- •Pregnancy
- •Breast feeding
研究组 & 干预措施
COXIB
40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery.
After retraction of parecoxib from the market:
Etoricoxib (Arcoxia, MSD) 120 mg given one hour before surgery
干预措施: parecoxib, valdecoxib, etoricoxib (Drug)
Dexamethasone
dexamethasone 8 mg iv
干预措施: Dexamethasone (Drug)
COXIB and dexamethasone
combination of coxib AND dexamethasone
干预措施: parecoxib, valdecoxib, parecoxib and dexamethasone (Drug)
结局指标
主要结局
Postoperative VAS score at rest 24 hours after surgery
时间窗: 24 hours
次要结局
- Cumulated opioid consumption(24 hours)