Effect of Oral Melatonin Versus Oral Pregabalin on Postoperative Pain and Anxiety Following Spine Surgery: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Degree of pain
研究概览
简要总结
This study aims to compare the efficacy of using Melatonin versus Pregabalin on postoperative pain and anxiety after spine surgeries.
详细描述
Spine surgery is one of the most common procedures performed every day which is associated with intense pain in the postoperative period, mostly in the first few days after surgery. Effective pain management leads to improved functional outcomes, early ambulation, prevention of chronic pain and early discharge.
Melatonin is neurohormone mainly secreted from the pineal gland by the suprachiasmatic nucleus. This neurohormone possesses a circadian secretion pattern and regulates the biological clock; it also offers antiemetic, analgesic, and anxiolytic effects.
Pregabalin is a structural analogue of gamma-aminobutyric acid that acts as a potent ligand for alpha 2-delta subunits of the voltage-gated calcium channels in the nervous system. Such action results in a reduction in the depolarization-induced influx of calcium, hence a reduction in the release of excitatory neurotransmitters including glutamate, noradrenaline, dopamine, and serotonin.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 21-60 years old.
- •Both sexes.
- •Patients of American Society of Anesthesiologists (ASA) physical status I & II.
- •Undergoing elective spine surgery.
排除标准
- •Patient refusal.
- •History of allergic reactions to melatonin or pregabalin.
- •Patients with cardiovascular disease (ischemic heart disease, Heart Failure, Arrythmia, Heart Block).
- •Patients with kidney disease with (plasma creatinine level > 1.5mg/dl).
- •Patients with liver disease with (aspartate transaminase, alanine transaminase, and bilirubin levels more than twice the upper limit of normal).
- •Psychological and cognitive disorders; dementia; major depression.
- •Circadian rhythm disorders such as chronic fatigue syndrome and drowsiness.
研究组 & 干预措施
Group C (Control Group)
Patients will be receive one oral placebo capsule the evening before surgery, one oral placebo capsule 2 hours prior to surgery, and one oral placebo capsule in the morning and one in the evening for 3 consecutive days postoperatively.
干预措施: Placebo capsule (Other)
Group M (Melatonin Group)
Participants will receive one 5 mg oral melatonin capsule the evening before surgery, one 5 mg oral melatonin capsule 2 hours prior to surgery, and one oral placebo capsule in the morning, and one 5 mg oral melatonin capsule in the evening, daily for 3 consecutive days postoperatively.
干预措施: Melatonin capsule (Drug)
Group P (Pregabalin Group)
Participants will receive one 75 mg oral pregabalin capsule the evening before surgery, one 75 mg oral pregabalin capsule 2 hours prior to surgery, and one 75 mg oral pregabalin capsule in the morning, and another in the evening, daily for 3 consecutive days postoperatively.
干预措施: Pregabalin capsule (Drug)
结局指标
主要结局
Degree of pain
时间窗: 3 days postoperatively
Postoperative pain will be assessed using the Visual Analogue Scale (VAS) at the following time points: upon arrival to the Post-Anesthesia Care Unit (PACU), and at 1, 2, 4, 6, 8, 12, and 24 hours, as well as at 12 and 24 hours on postoperative days 2 and 3.
次要结局
- Incidence of postoperative anxiety(3 days postoperatively)
- Postoperative analgesic consumption(3 days postoperatively)
- Postoperative sleep quality(3 days postoperatively)
研究者
Ahmed Hamdy Said Ayad
Assistant lecturer of Anesthesia, Surgical Intensive Care and Pain Medicine, Tanta University, Tanta, Egypt.
Tanta University