The Adjunctive Effect of Quercetin on Postoperative Pain Management Following Cesarean Section
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain intensity (2 hours)
研究概览
简要总结
The cesarean section is a common gynecological surgery, requiring effective pain management to prevent complications and immobility. Inadequate pain control can lead to longer hospital stays, higher readmission rates, and dissatisfaction with healthcare. Traditional analgesics, such as opioids, have proven effective in alleviating pain, but they can cause side effects. Therefore, researchers are exploring compounds that can reduce opioid analgesic needs and improve pain control. Quercetin has anti-nociceptive effects in rodent models of chronic pain, including inflammatory, neuropathic, and cancer pain. There are limited clinical studies on the effect of quercetin on acute or chronic pain. The current study is designed to assess the efficacy of preoperative quercetin administration in acute post-operative pain following cesarean section.
详细描述
The cesarean section is a common gynecological surgery, accounting for 40-50% of deliveries in public hospitals. Effective pain management following a cesarean delivery is crucial, as inadequate control can hinder a mother's capacity to care for her newborn. Uncontrolled postoperative pain can lead to patient immobility, increasing the risk of thromboembolic complications. Failure to adequately manage pain can result in economic and medical issues, including longer hospital stays, higher readmission rates, increased patient recovery costs, and patient dissatisfaction with the quality of healthcare provided.
Opioid medications, particularly when administered via injection, have proven effective in alleviating acute pain, but they are associated with dose-related side effects. Therefore, it is prudent to investigate compounds that can potentiate the analgesic effects of opioids, enabling improved pain control while minimizing opioid consumption. Quercetin, a flavonoid and polyphenol found in various plants and fruits, has been studied for its anti-inflammatory, free radical scavenging, antidiabetic, anticancer, cardiovascular, hepatoprotective, neuroprotective, antiplatelet, antibacterial, and anti-obesity effects. Recent evidence indicates quercetin possesses anti-nociceptive effects in rodent models of chronic pain, including inflammatory pain, neuropathic pain, and cancer pain.
Quercetin has great potential for clinical use in pain treatment, as its safety is well established. However, there are limited clinical studies on the effect of quercetin on acute or chronic pain. The current study aims to assess the efficacy of preoperative quercetin administration in acute post-operative pain following cesarean section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Referred to elective (non-emergency) cesarean section
- •Undergoing spinal anesthesia) with American Society of Anesthesiologists (ASA) classification I and II
- •Term gestational age
排除标准
- •History of seizures
- •Pre-eclampsia or eclampsia
- •Hypertension
- •Use of narcotic painkillers for 24 h before the intervention
- •Medications inducing neuropathy including Amiodarone, Metronidazole, Phenytoin & Colchicine.
- •Prolongation of cesarean section (more than 1.5 h)
- •Increase in the size of the incision
- •Occurrence of any unusual complication during surgery,
- •Failure of spinal anesthesia and its conversion to general anesthesia
- •Contraindications to spinal anesthesia
- •Use of interacting medication: fluoroquinolones, loratadine, fexofenadine, alvimopan, armodafinil
研究组 & 干预措施
Quercetin
receive 500mg of oral quercetin 1 hour preoperatively.
干预措施: Quercetin (Drug)
Placebo
receive placebo 1 hour preoperatively
干预措施: Placebo (Other)
结局指标
主要结局
Pain intensity (2 hours)
时间窗: 2 hours
Pain intensity using 10 cm Visual analog scale (VAS) scale
Pain intensity (6 hours)
时间窗: 6 hours
Pain intensity using 10 cm Visual analog scale (VAS) scale
Pain intensity (12 hours)
时间窗: 12 hours
Pain intensity using 10 cm Visual analog scale (VAS) scale
Pain intensity (24 hours)
时间窗: 24 hours
Pain intensity using 10 cm Visual analog scale (VAS) scale
次要结局
- Nausea & vomiting (24 hours)(24 hours)
- Rescue analgesia(24 hours)
- Nausea & vomiting (2 hours)(2 hours)
- Nausea & vomiting (6 hours)(6 hours)
- Nausea & vomiting (12 hours)(12 hours)
- Opioid intake(24 hours)
研究者
Nouran Omar El Said
Lecturer in. Pharmacy Practice & Clinical Pharmacy
Future University in Egypt
