COMBINATION OF CONTINUOUS FEMORAL BLOCK AND INTRAVENOUS PARECOXIB FOR POSTOPERATIVE ANALGESIA AFTER TOTAL KNEE ARTHROPLASTY. A DOUBLE BLIND PROSPECTIVE STUDY.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- MORPHINE CONSUMPTION WITH PCA BETWEEN TWO GROUPS
研究概览
简要总结
Combination of continuous femoral block with parEcoxib vs placebo. Investigation of morphine consumption, opioid sparing effects, VAS pain scores, haemodynamics, Anxierty scores, transfusion requirements , Range of motion and rehabilitation parameters between two groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PATIENTS ASA I-II UNDERGOING TOTAL KNEE ATRTHROPLASTY
排除标准
- •Exclusion criteria for both groups included:
- •Age younger than 40 years old or older than 80 years old
- •ASA > III
- •Obesity (>140 kg body weight)
- •Allergy to local anesthetics
- •History dependence on opioids
- •Contraindications for subarachnoid anesthesia or femoral block (coagulopathy, local infection, pre-existing neurological problems, patient refusal)
- •Contraindications to the administration of parecoxib
- •Severe hepatic or renal disease (serum creatinine ≥ 1.7 mg/dl)
研究组 & 干预措施
CONTINUOUS FEMORAL BLOCK AND PARECOXIB
Continuous infusion of0,2% of ropivacaine at 10 ml/h and 2 mls (40 mg) of iv parecoxib
干预措施: Parecoxib (Drug)
CONTINUOUS FEMORAL BLOCK AND PARECOXIB
Continuous infusion of0,2% of ropivacaine at 10 ml/h and 2 mls (40 mg) of iv parecoxib
干预措施: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2% (Drug)
CONTINUOUS FEMORAL BLOCK AND PLACEBO
Continuous infusion of 0.2% ropivacaine at 10 ml/h and 2 mls of iv N/S0.9%
干预措施: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2% (Drug)
CONTINUOUS FEMORAL BLOCK AND PLACEBO
Continuous infusion of 0.2% ropivacaine at 10 ml/h and 2 mls of iv N/S0.9%
干预措施: N/S 0.9% (Drug)
结局指标
主要结局
MORPHINE CONSUMPTION WITH PCA BETWEEN TWO GROUPS
时间窗: 36/h POSTOPERATIVELY
VAS PAIN SCORES BETWEEN TWO GROUPS
时间窗: 36/h POSTOPERATIVELY
HAEMODYNAMIC PARAMETERS BETWEEN TWO GROUPS
时间窗: During perioperative period
次要结局
- ANXIETY LEVELS(36 HOURS POSTOPERATIVELY)
研究者
Dr. Despoina Sarridou
ANAESTHESIOLOGIST
Asklepieion Voulas General Hospital