Comparison of the Two Different Doses of Dexamethasone on Persistent Mastectomy Pain
试验速览
- 阶段
- 4 期
- 入组人数
- 144
- 主要终点
- Change From Baseline in Persistent Surgical Pain on visual analogue scale (VAS).
研究概览
简要总结
This study evaluates the effect of dexamethasone on persistent surgical pain after mastectomy operations. Half of the participants will receive 0.1 mg/kg dexamethasone and the other half will receive 0.2 mg/kg dexamethasone.
详细描述
Breast cancer is the most frequent malignancy of middle age women (%32) and causes 19% of cancer-related deaths. Acute pain can contribute to the development of persistent surgical pain. Persistent postsurgical pain has been demonstrated to be clinically relevant in 10% to 50% of patients undergoing various common operations, including breast cancer surgery. The pathogenic mechanisms are multiple, including nerve damage related to surgical technique resulting in risk of intercostobrachial neuralgia, neuroma pain, or phantom breast pain. Multimodal analgesic strategies are important.Glucocorticoid steroids can also provide beneficial effects when administered in appropriate doses as part of a multimodal analgesic regimen in the perioperative setting. A recent study demonstrated that preoperative application of dexamethasone reduced postoperative nausea and vomiting and pain in patients after thyroidectomy.. It is possible that the already established reduction in prostaglandin synthesis mediated by dexamethasone contributes to the analgesia. And also there are a lot of mechanisms more.
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 (Care Provider, 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
- •18-70 years old, female patients
- •Written informed consent.
排除标准
- •American Society of Anesthesiologists Physical Status ˂3
- •Any contraindication to dexamethasone
- •Emergency or urgent procedure
- •Obesity body mass index ≥27 kg m2
- •Motion sickness and vertigo patients
- •Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
- •Significant hepatic (Alanine aminotransferase or Aspartate aminotrans > 2 times normal)
- •Renal (serum creatinine > 2 mg/dl) impairment
研究组 & 干预措施
0.1 mg/kg dexamethasone
0.1 mg/kg dexamethasone intravenous will be given 1 h before surgery.
干预措施: dexamethasone (Drug)
0.2 mg/kg dexamethasone
0.2 mg/kg dexamethasone intravenous will be given 1 h before surgery.
干预措施: dexamethasone (Drug)
结局指标
主要结局
Change From Baseline in Persistent Surgical Pain on visual analogue scale (VAS).
时间窗: Postoperative 3 months
At 3.month persistent surgical pain will be evaluated using (visual analogue scale=VAS) (score ranges from O (no pain) to 10 (worst possible pain) . The difference between these VAS scores will be evaluated statistically.
次要结局
- Change From Baseline in Acute Postsurgical Pain on visual analogue scale (VAS).(Postoperative 24 hours)
研究者
Onur Koyuncu
Assist.Prof
Mustafa Kemal University