Comparative Effects of Single Dose Preemptive Gabapentin or Amitriptyline on Postoperative Pain and Opioid Consumption in Single Level Lumbar Laminectomy and Diskectomy: A Double Blind RCT With Placebo Control
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 30% reduction in opium consumption in either study arms compared to the placebo group
研究概览
简要总结
The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive analgesia to reduce postoperative pain after lumbar diskectomies.
详细描述
Pain suppression plays a decisive role in patients' satisfaction following lumbar diskectomies, as the psychological component of the pain is a major cause of treatment failure.
Controversy exists whether preemptive prescription of gabapentin, as a known contributor to reduce postoperative pain, has a role in patients undergoing laminectomy for lumbar diskectomy or spinal canal stenosis.The aim of this study is to test the efficacy of amitriptyline and gabapentin in this group of neurosurgical patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Age:18 to 60
- •Weight: 60 to 80 Kg
- •ASA Class: I,II
- •Concordant physical and imaging findings in favor of symptomatic lumbar disk herniation
- •Single level lumbar disk herniation unresponsive to medical treatment
排除标准
- •Previous consumption of Gabapentin or Amitriptyline
- •Known allergy to investigated drugs
- •Reluctant to sign informed consent
- •Previous history of intolerance to narcotics
- •Simultaneous lumbar diskectomy and a fusion technique
- •Known renal failure
- •Pregnancy
- •Contraindications to Amitriptyline or Gabapentin prescription
- •Unable to use PCA
- •Habitual use of alcohol or opium
- •History of analgesic consumption during the last 24hours
研究组 & 干预措施
Gabapentin
Neurontin
干预措施: Gabapentin , Amitriptyline (Drug)
Amitriptyline
Elavil
干预措施: Gabapentin , Amitriptyline (Drug)
结局指标
主要结局
30% reduction in opium consumption in either study arms compared to the placebo group
时间窗: Within the first 24 hours after surgery
次要结局
- 30% reduction in pain according to visual analogue scale in either study arms compared to the placebo group(Within the first 24 hours after surgery)