CTRI/2025/08/092240尚未招募4 期
Effect of Gabapentin on sleep quality and post operative pain relief in patients undergoing lower limb trauma surgery
Department of Anaesthesia and Intensive Care1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年8月20日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Sleep quality using PSQI sleep score
研究概览
简要总结
This study will evaluate the effect of Gabapentin on sleep quality and postoperative pain relief in patients undergoing lower limb trauma surgery.Patients experience poor sleep and significant pain after lower limb trauma surgery.Gabapentin has already been used for treatment of neuropathic pain with the benefit of reduction in opioid requirements and improving function outcomes and sleep.We hypothesise that there is a difference in the response in terms of sleep scores and postoperative pain relief with the use of Gabapentin compared to a placebo drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age 18-65 years 2.American Society of Anaesthesiologists (ASA) physical status I and II 3.Lower limb surgery following trauma less than three months 4.Duration of surgery less than equal to 4 hours.
排除标准
- •Patients having head injury and/or polytrauma
- •Contraindications to spinal anaesthesia
- •Contraindications to Gabapentin
- •Pregnant and lactating women
- •Patients not able to understand VAS or PSQI scale
- •Patients having history of substance abuse
- •Patients with preexisting sleep disorders
- •Patients already on Gabapentin.
结局指标
主要结局
Sleep quality using PSQI sleep score
时间窗: 48 hours after surgery in ward
次要结局
- 1. Sleep quality using PSQI sleep score(2.Postoperative pain relief using VAS score)
研究者
Dr Vanita Ahuja
Government Medical College and Hospital Chandigarh , Sector 32-B
研究点 (1)
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