Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- change from preoperative pain score using a 10 point visual analog scale (VAS pain scale) at 1 week post surgery for PID
研究概览
简要总结
The purpose of this study is to compare the effect of pregabalin in reducing the neuropathic pain in postoperative patients who have undergone single level Microdiscectomy for prolapsed intervetebral lumbar disc.
详细描述
All patients were informed in detailed regarding the risk and complications and given written and informed consent, coming to our clinics were assessed by one of the senior team members of the spine, patient fulfilling the eligibility criteria were selected and included in the study. One week before the surgery the patients who met the eligibility criteria were randomized in a double-blind manner (participant and investigator) in a ratio of 1:1 into Group-A (Pregabalin 7mg, twice daily) or Group-B (Placebo, twice daily). The pain scores were recorded by VAS and Roland Morris score system on preoperative day compared to the scores on the 1st week postoperative follow-up.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with severe CLBP and/or leg pain
- •Patients with static or dynamic leg pain
- •Patients with leg pain resulting from localized lumbar or lumbosacral segmental instability
- •Spinal stenosis at levels L2-S1 or caused by isthmic spondylolisthesis (grade I and II)
排除标准
- •Patients with previous lumbar surgery
- •Patients allergic to gabapentinoids
- •Patients with renal impairments
- •Patients who are already on opioids, benzodiazepines, barbiturates, ethanol (alcohol)
- •Patient presented with diabetes and other drugs that depress the central nervous system
- •Patients who are already on ACE inhibitors as they may enhance the adverse/toxic effect of Pregabalin.
研究组 & 干预措施
Pregabalin
Participants received Pregabalin 75mg capsule twice daily from preoperative day to 1 week postoperative
干预措施: Pregabalin 75mg (Drug)
Pregabalin Placebo
Participants received Pregabalin placebo capsule matching Pregabalin twice daily from preoperative day to 1 week postoperative
干预措施: Placebo (Device)
结局指标
主要结局
change from preoperative pain score using a 10 point visual analog scale (VAS pain scale) at 1 week post surgery for PID
时间窗: Preoperative and one week postoperative
VAS pain scale is a validated, self-reported instrument assessing average pain intensity over the past 24 hours period. Possible scores being 0 (no pain) and 10 (worst possible pain). Change = (1 week post surgery - preoperative pain)
次要结局
未报告次要终点
研究者
Shahzaib Riaz Baloch
Senior Resident, Orthopedics Department
Ziauddin University