Preemptive Oral Gabapentin Versus Tramadol on Postoperative Pain After Knee Arthroscopy Done Under Spinal Anesthesia: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The intensity of postoperative pain
研究概览
简要总结
The aim of this study to evaluate the effect of preemptive oral gabapentin versus tramadol on postoperative pain after knee arthroscopy under spinal anesthesia.
详细描述
Orthopedic surgeries are frequently associated with moderate-to-severe postoperative pain that can decrease mobility in the immediate postoperative period, interfere with postoperative rehabilitation, and delay hospital discharge. Pain may also become chronic.
Spinal anesthesia is the most popular anesthesia technique worldwide in orthopedic lower limb surgeries. However, its relatively short duration of action may limit the excellent postoperative analgesic effect. Thus, many adjuvants had been used to improve postoperative analgesia and decrease consumption of postoperative analgesics.
Gabapentin is a gamma aminobutyric acid analogue that is known as an anticonvulsant drug. This drug is tolerated well and has known effects on pain and anxiety.
Tramadol, a commonly used postoperative analgesic, is a synthetic centrally acting opioid analgesic. The various actions include inhibition of noradrenaline and serotonin reuptake, and also inhibition of M1 and M3 muscarinic receptors
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old.
- •Both sexes. American Society of Anesthesiologists (ASA) physical status I and II
- •Undergoing knee arthroscopy procedures.
- •under spinal anesthesia.
排除标准
- •Cardiac patients.
- •Patients with known allergy to drug of study.
- •Prolonged administration of NSAIDS or other analgesics due to chronic pain of any reason.
- •Cirrhosis.
研究组 & 干预措施
Gabapentin
Patients will receive oral gabapentin 600 mg 1 hour before the surgery.
干预措施: Gabapentin (Drug)
Tramadol
Patients will receive oral tramadol 100 mg 1 hour before the surgery.
干预措施: Tramadol (Drug)
结局指标
主要结局
The intensity of postoperative pain
时间窗: 24 hours postoperatively
Assessment of postoperative pain will be done with a analogue scale (VAS; 0=no pain and 10=worst possible pain). At discharge post-operative and every 2 hours postoperative till 12hours then every 6 hours for the first 24 hours.
次要结局
- The incidence of side effects(24 hours postoperatively)
- The total amount of morphine consumption in the first 24-hour postoperative(24 hours postoperatively)
- The time first rescue analgesia(24 hours postoperatively)
研究者
Laila Elahwal
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Tanta University