Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair: Prospective Randomized Double-blinded Placebo Controlled Comparison of Lornoxicam and Paracetamol
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative pain and comfort
研究概览
简要总结
The purpose of this study is to determine whether lornoxicam or paracetamol is more effective in providing pre-emptive analgesia for adult patients undergoing elective unilateral inguinal hernia repair under general anesthesia.
详细描述
Early postoperative pain is the major cause that may restric physical activity of the patients and delay in returning work. Newer non-steroid analgesic drugs (NSAD) can be helpful in overcoming this problem, especially in pre-emptive use. In this prospective randomized placebo controlled double blinded study we aimed to determine whether lornoxicam, as a NSAD, or paracetamol is more effective in providing pre-emptive analgesia for patients undergo elective unilateral inguinal hernai repair under general anesthesia. 60 patients above the age of 18, ASA score of I to III will be assigned into 3 groups. All the patients will be operated under general anesthesia. Recurrent hernia cases, pregnant or lactated women, patients allergic to the two drugs, patients with documented gastric disorders or bleeding disorder or under anticoagulent therapy will be excluded.
Group designs:
Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.
Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inguinal hernia
- •unilateral hernia
- •general anesthesia
- •elective repair
排除标准
- •drug allergy
- •bilateral hernia
- •local anesthesia
- •local blockade
- •regional anesthesia
- •emergency surgery
- •complicated hernia
- •recurrent hernia
研究组 & 干预措施
Placebo Control
Group I (Placebo Control) 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
干预措施: Sterile Saline (Other)
Lornoxicam
Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.
干预措施: Intravenous lornoxicam (Drug)
Paracetamol
Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
干预措施: Intravenous paracetamol (Drug)
结局指标
主要结局
Postoperative pain and comfort
时间窗: 24 and 48 hours
次要结局
- Postoperative late pain complaint and quality of life(4. week)