Impact of Perioperative Vitamin C on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- The incidence of chronic post mastectomy pain
研究概览
简要总结
This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of perioperative vitamin C on acute and chronic post mastectomy pain after breast cancer surgery
详细描述
There is cumulative evidence that postoperative pain is closely associated with subsequent persistent pain lasting months. The International Association for the Study of Pain has defined chronic postsurgical pain (CPSP) as a pain that develops after surgical intervention and persists at least 2 months.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥ 18years, with primary unilateral breast cancer and scheduled for lumpectomy, partial or total mastectomy with or without axillary lymph node dissection or modified radical mastectomy.
排除标准
- •- (1) Patients with renal stones or renal insufficiency, patients suffering from nausea and vomiting, gastroesophageal reflux or patients with chronic pain state.
- •(2) Intake of analgesic within 24 hours before surgery. (3) Patients unable to comply with the study protocol for any reason. (4) Contraindications to paravertebral block (PVB) such as allergy to local anesthetics, infection, or coagulopathy.
研究组 & 干预措施
Vitamin C group
patients in this group will receive 2 gm vitamin C orally 1 hour before surgery and will receive 0.5 gm vitamin C per day orally for 50 days starting from the 2nd postoperative day.
干预措施: vitamin C group (Drug)
Placebo group
patients in this group will receive placebo tablets with the same manner.1 hour before surgery and for 50 days starting from the 2nd postoperative day.
干预措施: placebo group (Other)
结局指标
主要结局
The incidence of chronic post mastectomy pain
时间窗: 6 months after surgery
Chronic pain will be assessed at 3, 6 months after surgery. Chronic pain will be defined as pain at the surgical site greater than or equal to 3 out of 10 on item 5 of the Brief Pain Inventory (item 5: "Please rate your pain by circling the one number that best describes your pain on the average in the past 24h, no pain = 0, worst pain = 10")
次要结局
- The degree of acute postoperative pain(48 hours postoperative)
- The amount of total opioid dose in 48 hours after surgery(48 hours postoperative)
- The incidence of adverse effects(48 hours postoperative)
- The incidence of chronic pain at 9, 12 months after surgery(12 months after surgery)
研究者
Osama Rehab
Lecturer of anesthesiology, S.I.C.U and pain medicine Tanta university
Tanta University