Efficacy of Pre-emptive Different Doses of Oral Pregabalin Versus Celecoxib on Sevoflurane and Analgesic Consumption in Patients Subjected for Elective Lumbar Spine Fixation Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- pain control
研究概览
简要总结
The anti-epileptic drugs such as gabapentin and other non-steroidal anti-inflammatory drugs (NSAID) such as celecoxib were used as a part of multimodal analgesia to control such pain. Gabapentin is an anticonvulsant drug that has analgesic effect in post-herpetic neuralgia, diabetic neuropathy, and neuropathic pain. Celecoxib is one of the NSAIDs, that its analgesic effect is reported in various studies by cyclooxygenase-2 (COX-2) inhibitor.
The aim of this randomized double-blinded study was to asses and compare the efficacy of using gabapentin versus celecoxib as a part of multimodal analgesia in perioperative hemodynamic control and pain relief in patients underwent posterior approach lumbar spine disc fixation surgery.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American society of anesthesiologists (ASA) I and II, aged between 21-60 years old scheduled to undergo elective posterior approach lumbar spine disc surgery
排除标准
- •Patients with a known sensitivity to celecoxib or pregabalin, psychotic disorder or cognitive impairment, history of drug dependency or substance addiction, history of chronic medical disease, the presence of coagulation disorders or pregnancy, were excluded from the study.
研究组 & 干预措施
Group (C)
received celecoxib 200 mg 2 hours preoperative and the same dose 6 hours postoperative.
干预措施: Celecoxib capsules (Drug)
Group (G)
received gabapentin 300 mg capsule 2 hours preoperative and the same dose 6 hours postoperative.
干预措施: Pregabalin 150mg (Drug)
结局指标
主要结局
pain control
时间窗: Change from Baseline Visual Analogue Scale every 4 hours for 48 hours (0=no pain 10=most sever pain)
Visual Analogue Scale for pain measurement.
次要结局
未报告次要终点
研究者
Alaa Ali M. Elzohry
Lecturer of Anesthesia, ICU and Pain Relief
Clinical Research Consultants, Inc.