EVALUATION OF ORAL USE OF DEXKETOPROFEN/TRAMADOL IN ACUTE POSTOPERATIVE PAIN IN PATIENTS UNDERGOING TOTAL HIP REPLACEMENT WITH A MINIMALLY INVASIVE ANTERIOR APPROACH (AMIS).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Pain score in 8hours
研究概览
简要总结
Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions . When unrelieved or poorly controlled, it is associated with medical complications, poor patient satisfaction and increased risk of developing chronic pain. Dexketoprofen is a new NSAID treating acute postoperative pain and when it combined with tramadol may have a better effect. The purpose of this study is to evaluate the analgesic effect of the oral use of the combination of dexketoprofen/tramadole on the reduction of postoperative pain after total hip arthroplasty with minimal invasive anterior approach (AMIS).
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
- Single (Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •unilateral total hip arthroplasty with a direct anterior minimal invasive technique
- •ASA score I or II
- •signed written informed consent form
- •3 days hospitalization
- •45-80 years old
- •primary Total hip arthroplasty
排除标准
- •allergy to any given drugs
- •contraindications for spinal anesthesia
- •active bleeding
- •renal failure ( gfr< 90ml/h)
- •hepatic failure ( abnormal sgot,sgpt,γgt)
- •heart failure
- •history of gastrointestinal bleeding
研究组 & 干预措施
Group A
Group A was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg.
Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine.
Group A was given the oral combination dexketoprofen/tramadole (25mg/75mg) 2h after surgery every 8h for 72h.
干预措施: Dexketoprofen/tramadol (27mg/75mg) (Drug)
Group A
Group A was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg.
Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine.
Group A was given the oral combination dexketoprofen/tramadole (25mg/75mg) 2h after surgery every 8h for 72h.
干预措施: Ropivacaine Hydrochloride 7.5 MG/ML (Drug)
Group A
Group A was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg.
Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine.
Group A was given the oral combination dexketoprofen/tramadole (25mg/75mg) 2h after surgery every 8h for 72h.
干预措施: Levobupivacaine Hydrochloride (Drug)
Group B
Group B was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg.
Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine.
Group B received postoperative analgesia with intravenous tramadole 75mg and paracetamol 1g every 8h with the first dose beginning 2h after the end of the surgery. For 72h
干预措施: Tramadol hydrochloride (Drug)
Group B
Group B was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg.
Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine.
Group B received postoperative analgesia with intravenous tramadole 75mg and paracetamol 1g every 8h with the first dose beginning 2h after the end of the surgery. For 72h
干预措施: Paracetamol (Drug)
Group B
Group B was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg.
Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine.
Group B received postoperative analgesia with intravenous tramadole 75mg and paracetamol 1g every 8h with the first dose beginning 2h after the end of the surgery. For 72h
干预措施: Ropivacaine Hydrochloride 7.5 MG/ML (Drug)
Group B
Group B was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg.
Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine.
Group B received postoperative analgesia with intravenous tramadole 75mg and paracetamol 1g every 8h with the first dose beginning 2h after the end of the surgery. For 72h
干预措施: Levobupivacaine Hydrochloride (Drug)
结局指标
主要结局
Pain score in 8hours
时间窗: 8 hours
Pain score with the visualised analogue scale in 8hours
Pain score in 24hours
时间窗: 24 hours
Pain score with the visualised analogue scale in 24 hours
Pain score in 48 hours
时间窗: 48 hours
Pain score with the visualised analogue scale in 48 hours
Pain score in 72 hours
时间窗: 72 hours
Pain score with the visualised analogue scale in 72 hours
Total analgesic consumption
时间窗: 24 houra
Total analgesic consumption as rescue analgesia the first 24 hours
次要结局
- Side effects(72 hours)
研究者
Elena Nikolakopoulou
MD
KAT General Hospital