Effect of Melatonin On Pain In Patients Undergoing Lower Limb Surgery: A Randomized Open Label study- PG Dissertation
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1) To assess the effect of Melatonin on post operative pain relief in patients undergoing lower limb orthopedic surgery using Visual Analog Scale
研究概览
简要总结
Post operative pain is common in patients undergoing surgery and effective control is required to reduce post operative complications, improve patient satisfaction and facilitate early recovery. Melatonin was observed to be effective in treatment of sleep disorder, anxiety and painful conditions. Melatonin also has antiemetic, analgesic and anti-inflammatory effects. While many studies have investigated the analgesic effect of melatonin, there are few studies evaluating its role in post operative pain relief following surgical procedures for lower limb fractures in india.
OBJECTIVES OF STUDY:
-
To assess the effect of Melatonin on post operative pain relief in patients undergoing lower limb orthopedic surgery using Visual Analog Scale
-
To study the effect of melatonin on peri-operative anxiety using Visual Analog Scale for Anxiety (VAS-A)
-
To evaluate the safety profile of melatonin using WHO causality scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •patients undergoing elective lower limb orthopedic surgery under spinal anesthesia 2)patients belonging to American society of anesthesiologists (ASA) grade 1 and grade 2.
排除标准
- •patients who have used opioids within 12 hours before the surgery 2)chronic alcoholics 3)patients on nifedipine, benzodiazepines, non-benzodiazepines and beta blockers within a week before admission 4)patients with sleep disorders, diabetes mellitus, depressive disorder, allergy to study drugs, abnormal baseline liver function tests or expected compliance problems due to known psychiatric disease and epilepsy 5)pregnant or lactating women.
结局指标
主要结局
1) To assess the effect of Melatonin on post operative pain relief in patients undergoing lower limb orthopedic surgery using Visual Analog Scale
时间窗: 1) Intensity of pain measured using Visual Analog Scale at baseline(before study medication is administered) and at 2,4,6,8,12,24,48,72,96 and 120 hours. | 2) BPAS score at baseline and at 12,24,48,72,96 and 120 hours. | 3) FAS at baseline and at 2,4,6,8,12,24,48,72,96 and 120 hours. | 4) VAS-A score at baseline, 6, 12 and 24hrs post surgery
2) To study the effect of melatonin on peri-operative anxiety using Visual Analog Scale for Anxiety (VAS-A)
时间窗: 1) Intensity of pain measured using Visual Analog Scale at baseline(before study medication is administered) and at 2,4,6,8,12,24,48,72,96 and 120 hours. | 2) BPAS score at baseline and at 12,24,48,72,96 and 120 hours. | 3) FAS at baseline and at 2,4,6,8,12,24,48,72,96 and 120 hours. | 4) VAS-A score at baseline, 6, 12 and 24hrs post surgery
3) To evaluate the safety profile of melatonin using WHO causality scale
时间窗: 1) Intensity of pain measured using Visual Analog Scale at baseline(before study medication is administered) and at 2,4,6,8,12,24,48,72,96 and 120 hours. | 2) BPAS score at baseline and at 12,24,48,72,96 and 120 hours. | 3) FAS at baseline and at 2,4,6,8,12,24,48,72,96 and 120 hours. | 4) VAS-A score at baseline, 6, 12 and 24hrs post surgery
次要结局
未报告次要终点
研究者
Mohammed Faisel H A
Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research