Effect of preoperative melatonin on postoperative pain in patients undergoing lumbar spine surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Postoperative VAS at predefined time intervals.
研究概览
简要总结
Background
Postoperative pain is frequently under-treated, impacting recovery, increasing complications, and prolonging hospital stays. Melatonin, a pineal hormone known for regulating circadian rhythms, also exhibits analgesic, anti-inflammatory, antioxidant, and anxiolytic properties. While its role in managing chronic pain and perioperative anxiety is well-established, evidence for its efficacy in acute postoperative pain, especially following spine surgery, remains limited.
Objective
To evaluate the effect of preoperative melatonin administration (6 mg orally) on postoperative pain scores in patients undergoing elective lumbar spine surgery under general anesthesia.
Primary Objective
To assess postoperative pain scores (VAS) over a 24-hour period.
Secondary Objectives
Total intraoperative analgesic requirement
Cumulative postoperative fentanyl consumption (via IV PCA) over 24 hours
Time to first rescue analgesia
Incidence of opioid-related side effects (nausea, vomiting)
Patient satisfaction score
Study Design
Type Interventional
Design Prospective, double-blinded, randomized, placebo-controlled trial
Sample Size 50 patients (25 in each group), accounting for potential dropouts
Setting Department of Anaesthesia & Intensive Care, Government Medical College & Hospital, Chandigarh
Inclusion Criteria
Adults aged 18–70 years (ASA I–II) undergoing elective lumbar spine surgery
Exclusion Criteria
Allergies to study drug, morbid obesity, pregnancy, opioid/alcohol abuse, severe systemic illness, or mental impairment
Methodology
Patients will be randomized into two groups:
Group M 6 mg oral melatonin 2 hours preoperatively
Group P Matching placebo tablet(10mg pyridoxine) 2 hours preoperatively
Standard anesthesia protocol will be followed. Postoperatively, all patients will receive paracetamol IV and PCA fentanyl. Pain will be measured using the Visual Analogue Scale (VAS) at 1, 2, 3, 6, 12, and 24 hours. Additional data will include total fentanyl consumption, side effects (assessed by Likert scale), and patient satisfaction.
Expected Outcomes
This study aims to determine whether preoperative melatonin reduces postoperative pain and opioid requirement without increasing adverse effects, thereby supporting its use in multimodal analgesia for spinal surgeries.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing elective surgery for lumbar spine surgery
- •Age between 18 to 70 years of either sex
- •Patients with American Society of Anaesthesiologists (ASA) physical status class I and II.
排除标准
- •Allergy to the study drug
- •Morbid obesity (BMI more than35 kg/m2)
- •Pregnant women
- •Alcohol Abuse or Opioid Abuse
- •Severe cardiorespiratory, cerebrovascular, renal, hepatic or musculoskeletal diseases
- •Mental Impairment.
结局指标
主要结局
Postoperative VAS at predefined time intervals.
时间窗: VAS at rest -immediate post operative period | At 1 hour | At 2 hour | At 4 hour | At 6 hour | At 12 hour | At 24 hour | VAS at Movement-immediate post operative period | At 1 hour | At 2 hour | At 4 hour | At 6 hour | At 12 hour | At 24 hour
次要结局
- 1. Post operative nausea vomiting score(2. Additional intraoperative analgesia)
研究者
Amandeep Singh
Government Medical college and Hospital, Chandigarh