A Comparison of Nefopam-propacetamol Combination and Propacetamol for Postoperative Quality of Recovery After Laparoscopic Nephrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Quality of Recovery
研究概览
简要总结
The multimodal analgesia for postoperative pain aims for optimal analgesia through additive or synergic drug effects. The multimodal analgesia results in the use of smaller doses of opioids and lowering opioid-related side effects.
Non-opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), propacetamol (prodrug of acetaminophen), nefopam are often given along with opioids as part of multimodal analgesia after major surgery.
NSAIDS, commonly used non-opioid analgesics, have gastro-intestinal, renal, and cardiac side effects.
In contrast, propacetamol or nefopam, two drugs with central analgesic effects, can be safely used as analgesic adjuvants with opioid after nephrectomy, because these drugs do not alter renal function or cause hemorrhagic complications.
Recent study demonstrated that the antinociceptive properties of paracetamol (intravenous acetaminophen) associated with the analgesic effectiveness of nefopam could explain the observed synergy of the combination.
The aim of this randomized, double-blinded study is to compare the opioid-sparing effect and analgesic efficacy, as well as quality of recovery, of nefopam-propacetamol combination and propacetamol in patients undergoing laparoscopic nephrectomy.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA status 1-3,
- •aged 20 to 65 years,
- •undergoing laparoscopic nephrectomy
排除标准
- •Severe cardiac disease,
- •hepatic insufficiency,
- •chronic kidney disease stage ≥3,
- •preoperative use of analgesics(corticosteroids, opioid),
- •chronic alcoholics,
- •hemolytic anemia,
- •convulsions
研究组 & 干预措施
nefopam-propacetamol combination group
干预措施: nefopam-propacetamol combination (Drug)
propacetamol alone group
干预措施: propacetamol alone (Drug)
结局指标
主要结局
Quality of Recovery
时间窗: at 24 hours postoperative
Quality of recovery questionnaire score at 24 hours after surgery
次要结局
- Postoperative opioid consumption(at 24 and at 48 hours after surgery)