Influence of Preoperative Vitamin D Level on Postoperative Pain in Breast Cancer Surgery Patients: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Incidence of moderate to severe postoperative pain
研究概览
简要总结
Vitamin D deficiency is a general problem that vigorously affects human health . Breast cancer is the most frequently diagnosed life-threatening cancer in women and the leading cause of cancer death among women.Vitamin D deficiency is common in breast cancer patients and some evidence suggests that low vitamin D status enhances the risk for disease development or progression .
Though the relationship between vitamin D and breast cancer is unclear . Several research studies currently support vitamin D deficiency as a risk factor for breast cancer. Observational studies have also revealed significant relationships of vitamin D with breast cancer, colorectal cancer, prostate cancer and pancreatic cancer .
However, no work has been done to investigate the relationship between vitamin D deficiency and acute postoperative pain in breast cancer surgery patients. In the current study we will investigate the relationship between preoperative vitamin D levels and acute postoperative pain in cancer breast surgery patients.
The aim of current study is to investigate the relationship between preoperative vitamin D levels and acute postoperative pain in breast cancer surgery patients.
详细描述
This study will be performed in the FAYOUM University Hospital after the local Institutional Ethics Committee and local institutional review board approval. Newly diagnosed and pathologically proven breast cancer patients who are prepared for elective breast cancer surgery will be recruited from the general surgery department of our hospital. The study design will be prospective observational study. A detailed informed consent will be signed by the eligible patients before recruitment.
Measurement of vitamin D:
The characteristics of 25 (OH) D3 are relatively longer half-life than 1.25 (OH)2 D3, stability, strong detection repeatability, and no biological activity. Generally, systemic levels of the more stable 25 (OH) D3 are considered to be the best index to reflect status of vitamin D in the individual patient .
study design:
Serum 25(OH)D levels will be measured preoperative . Patients will be divided into two groups :
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of moderate to severe postoperative pain
时间窗: at 12 hours after surgery
Incidence
次要结局
- Pain assessment by NRS(24 hours before operation during the preoperative visit)
- Total fentanyl consumption (in micrograms)(intraoperative till end of the operation)
- Incidence of adverse effects(during 1st 24 hours postoperative)
- Heart rate(baseline, every 30 minutes up to end of the operation)
- Non- invasive mean arterial blood pressure(baseline, every 30 minutes up to end of the operation)
- Hospital stay(from the date of the operation to the date of discharge from hospital)
- Postoperative pain scores(at times: hour zero, hour 6, hour12, hour18, hour24 postoperative.)
- American Society of Anaesthesiologists(24 hours before operation)
- Preoperative Serum 25(OH)D level (nmol/L)(24 hours before operation)
- Duration of surgery(from start to the end of operation)
- Total tramadol consumption(within 1st 24 hours postoperative)
- Patient satisfaction(up to 2 days postoperative)
- Previous associated comorbidities(24 hours before operation)
研究者
Mohamed Ahmed Hamed
Associate professor of anaesthesiology
Fayoum University