Effect of Preoperative Melatonin on Postoperative pain relief and Quality of Recovery in patients undergoing spinal fusion surgery: A randomised, triple-blinded, placebo-controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Time to request for 1st rescue analgesia in the postoperative period
研究概览
简要总结
Postoperative pain plays a significant role in the recovery of patients as it can lead to patient discomfort and increase the duration of hospital stay. Pain and anxiety positively interact with each other. Opioids and NSAIDs are most commonly used for postoperative pain relief, leading to several undesirable side effects. Earlier studies have demonstrated the analgesic action of Melatonin in various surgeries without unwanted side effects. It also has a role in improving the Quality of Recovery. To the best of our knowledge, no studies have demonstrated the analgesic properties of Melatonin in spinal fusion surgery. So, we hypothesize that Melatonin will be effective in relieving Postoperative pain and Quality of Recovery in spinal fusion surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •ASA I & II patients planned for elective spinal fusion surgery (one or two levels).
排除标准
- •Refusal to give consent, Spinal fusion surgery involving cervical spine and at different sites, Allergy to Melatonin, Pregnancy, BMI > 30kg/m2, Use of narcotic painkillers, gabapentin and tricyclic antipsychotics 72 hours before the intervention, history of any psychiatric disorder, chronic hepatic or renal disorder.
结局指标
主要结局
Time to request for 1st rescue analgesia in the postoperative period
时间窗: 1st 24 hours after surgery
次要结局
- VAS Score(1 hour, 6 hour, 12 hour, 24 hour postoperatively)
- Total amount of analgesics (Intravenous Tramadol in milligrams)(1st 24 hours postoperatively)
- QOR 15 Score(preoperative and 24 hours postoperative)
- CRP and IL-6 levels(preoperative and 24 hours postoperative)
研究者
Dr Ananya Ray
AIIMS Bhubaneswar