Comparing Opioid Vs Non Opioid Analgesics for Postoperative Pain Management in Unilateral Primary Open Inguinal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual analogue scale - pain score
研究概览
简要总结
To control post-operative pain, multiple drugs are available, and in the western countries opioids are preferred. However, they have their own side effects, and so to reduce their dependence, multiple adjuncts are used. We compared the use of opioids vs just non steroidal anti-inflammatory drugs on post-operative pain control following inguinal hernia surgery
详细描述
Inguinal hernia repair is one of the most common surgeries performed by general surgeons worldwide. The preferred procedure for primary open inguinal hernias is open mesh repair (tension-free)-also called Lichtenstein repair. Opioids remain the mainstay for post-operative analgesia, however, they have a tendency for dependence along with other side effects. Non-steroidal anti-inflammatory drugs (NSIADs) have been used as adjuncts to decrease the use of opioids, however, usually NSAIDs are not used in isolation following surgery. We compared post-operative analgesia following primary open inguinal hernia repair, with patients receiving only opioids vs patients only receiving NSAIDs. 60 patients were randomized in to 2 groups. Group A patients received tramadol injection (opioid) every 8 hours, while patients in Group B received injection ketorolac (NSAID) every 8 hourly. Pain was measured using visual analogue score at 2-, 6-, 12- and 24-hours following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective primary unilateral open inguinal hernia repair under spinal anesthesia - Lichtenstein repair with prolene mesh
- •ASA I or II
- •Ages 18 - 65
排除标准
- •Patient on chronic pain meds
- •Patient receiving analgesics 24hrs prior to surgery
- •Incarcerated or strangulated hernia or recurrent hernia
- •BMI >40
- •Allergic to medications being tested in this study
研究组 & 干预措施
Tramadol
Patients received injection tramadol 50 mg intravenously every 8 hourly following surgery
干预措施: Pain management after surgery (Drug)
Ketorolac
Patients received injection tramadol 30 mg intravenously every 8 hourly following surgery
干预措施: Pain management after surgery (Drug)
结局指标
主要结局
Visual analogue scale - pain score
时间窗: 2-, 6-, 12-, 24-hours following surgery
Visual analogue score to quantify pain following laparoscopic cholecystectomy. Maximum value is 10 (which means worst pain), and minimum value is 0 (which means no pain).
次要结局
- Flatus(within 24 hours following surgery)
- nausea/vomiting(within 24 hours following surgery)
- Time to ambulation(within 24 hours following surgery)
- rescue analgesia(within 24 hours following surgery)
- Mean arterial pressure(2-, 6-, 12-, 24-hours following surgery)
- Heart rate(2-, 6-, 12-, 24 hours)
- oxygen saturation(2-, 6-, 12-, 24 hours)
研究者
Syed Moiz Ahmed
Post-graduate resident, Principle Investigator, Department of General Surgery
Pakistan Air Force (PAF) Hospital Islamabad