Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- Difference in NLR
研究概览
简要总结
The study will test the hypothesis that inflammatory markers measured at 24 hours after breast cancer surgery will be lower in patients receiving PECS II and PIFB blocks, supplemented with dexmetomidine compared to standard care group.
详细描述
Breast cancer is a devastating disease. Surgery is the mainstay of treatment which can lead to ongoing patient difficulties. Severe acute pain after surgery is one of major risk factors for developing persistent postsurgical pain. Subsequent physiological stress caused by this severe pain may negatively influence the immune response leading to a worse prognosis.
Regional anesthesia is very effective in management of peri- and postoperative pain. Epidural block, paravertebral block and intercostal nerve blocks have been proven over time to be effective in preventing postoperative pain. However, their widespread use has been hampered by technical difficulty and inherent risks.
Unlike the aforementioned blocks, novel thoracic wall blocks, namely modified pectoralis block (PECS II) and pecto-intercostal fascial block (PIFB) are safe, simple and effective.
Efforts to prolong and improve analgesia following single shot blocks has led to the introduction of adjuvants into the local anesthetic. Dexmetomidine is a superselective Alpha 2 agonist with a proven ability to prolong the duration of neuraxial, peripheral nerve and interfascial plane blocks.
Chronic inflammation is recognized as a risk factor for initiation, progression and further spread of malignant growth. Surgical insult leads to inflammatory response which facilitates the development of a metastatic disease. Many inflammatory markers were proven to be independent prognostic factors in breast cancer patients.
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 (Participant, Outcomes Assessor)
盲法说明
Intervention will be done under general anesthesia so participant will be blinded and primary outcome which will be laboratory test will be assessed by a person not aware of intervention.
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 with ductal carcinoma (stage 1 to 3) undergoing primary potentially curative unilateral mastectomy.
- •Older than 18 years
- •ASA I-III
排除标准
- •Weight < 50 kg
- •BMI > 35
- •Allergy to local anaesthetic or dexmetomidine
- •Contraindications to NSAIDs use
- •Local infection over block site
- •Coagulopathy
- •Preexisting chronic pain
- •Pregnancy
- •Autoimmune disease
- •Inability to give informed consent
研究组 & 干预措施
Block group
Patients in a Block group will be anesthetized and receive PECS II+PIFB with dexmetomidine prior to their surgery.
干预措施: Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB) (Procedure)
Control group
Patients in a Control group will receive a standard general anesthesia the same way as patients in the interventional group but without regional anesthesia.
结局指标
主要结局
Difference in NLR
时间窗: 24 hours after surgery
Difference in neutrophil-lymphocyte ratio (NLR) between the intervention group and the standard care group measured at 24 hours after breast cancer surgery
次要结局
- Intraoperative opioids(Duration of surgery)
- Pain after surgery(1,6,12,18,24 hours after surgery)
- Markers of inflammation(24 hours after surgery)
- Opioid consumption(24 hours)