Comparative study of analgesic efficacy and tolerability of oral tapentadol-paracetamol combination vs. oral tramadol-paracetamol combination for postoperative pain relief in patients undergoing hernia surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain at rest and on movement measured by visual analog scale (VAS)
研究概览
简要总结
Pain after surgery is inevitable and if not adequately controlledcan adversely affect both physical and physiological functions. Inadequaterelief of postoperative pain can prolong recovery, increase the duration ofstay in the hospital and increase health care costs.Unrelievedacute pain is often associated with sleeplessness, anxiety, fear, ordemoralization and may lead to the development of chronic pain syndromes. Effective pain managementis an important component of post-surgical care. The latest innovation in this class of compounds with the novelmechanism of action is tapentadol. Tapentadol shares the same dual-actionmechanism as tramadol, but is devoid of the the disadvantages of tramadolmentioned. Thus, it represents a theoretical and practical advancement inpain management.To the best of our knowledge, so far there areno studies comparing the analgesic efficacy and tolerability of oraltapentadol-paracetamol combination vs. oral tramadol-paracetamol combinationfor postoperative pain relief in patients undergoing hernia surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •Under going inguinal hernia surgery ASA status I and II.
排除标准
- •1.ASA status > III 2.Major co-existing medical illness (especially severe asthma/COPD, epilepsy, uncontrolled hypertension or diabetes, liver or renal disease) 3.Patients with paralytic ileus 4.Patients on tricyclic antidepressants, anticonvulsants, Mono amino oxidase inhibitors, antipsychotics or serotonin-norepinephrine reuptake inhibitors (i.e. within 30 days)
- •Known hypersensitivity to any of the study medications.
结局指标
主要结局
Pain at rest and on movement measured by visual analog scale (VAS)
时间窗: During the postoperative period at intervals of 0 hour (when the first dose of the combination is administered, i.e., when the block level recedes to T10), 2, 4, 8, 12, and 24 h
次要结局
- Haemodynamics,Patient Satisfaction Scale , rescue analgesics, adverse effects(During the postoperative period at intervals of 0 hour (when the first dose of the combination is administered, i.e., when the block level recedes to T10), 2, 4, 8, 12, and 24 h)