Effect of Preoperative Oral Melatonin With Intra Articular Analgesia on Post-Operative Pain Relief After Arthroscopic Anterior Cruciate Ligament Reconstruction Under Spinal Anesthesia. A Randomized Comparative Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Time to first analgesic requirement
研究概览
简要总结
Anterior Cruciate Ligament Reconstruction (ACLR) is a common orthopedic procedure that is accompanied by moderate to severe postoperative pain and is primarily performed on an outpatient basis.
详细描述
Many different pain control treatments are used in the management of patients after ACLR, including various permutations of nerve blocks, nerve block adjuncts (NBAs), intra-articular injections, intravenous (IV), oral medications, and cryotherapy, as well as compression stockings. Despite this, no gold-standard postoperative analgesia guideline has emerged.
Melatonin (N-acetyl-5-methoxytryptamine) is a naturally-occurring hormone in the human body and offers antiemetic, analgesic, and anxiolytic effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective unilateral arthroscopic reconstruction of the anterior cruciate ligament (ACL) under spinal anesthesia, aged from 18 to 65 years old, and who are American Society of Anesthesiologists (ASA) physical status I or II of either sex
排除标准
- •Contraindications to neuraxial anesthesia (e.g. allergy to local anesthetics, coagulopathies, infection in the area)
- •History of cardiovascular, cerebrovascular, respiratory, or psychological disorders
- •Chronic pain syndrome and/ or opioid use
- •Regular consumption of analgesics, corticosteroids or anticonvulsants
- •A known allergy to melatonin
- •Patients with diabetes mellitus, sever hypertension, liver or renal dysfunction
- •Cognitive disorders (dementia, major depression)
- •Circadian rhythm disorders (such as chronic fatigue syndrome and drowsiness)
- •Pregnancy/ lactating
- •Body mass index 35 kg/m2 or more,
- •Patient refusal.
研究组 & 干预措施
Group M
Patients will receive oral melatonin 10 mg (two 5 mg tablets) one hour before the operation plus intra-articular analgesia at the end of surgery.
干预措施: Melatonin (Drug)
Group C
Patients will receive two oral inert starch tablets of the same shape and color one hour before the operation plus intra-articular analgesia at the end of surgery.
干预措施: Starch tablets (Other)
结局指标
主要结局
Time to first analgesic requirement
时间窗: 24 hours after surgery
Assessed in minutes
次要结局
- Postoperative pain intensity(24 hours after surgery)
研究者
Seham Mohamed Moeen Ibrahim
Assiut University
Assiut University