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临床试验/CTRI/2020/06/025582
CTRI/2020/06/025582招募中不适用

Effect of Regional Anaesthesia on immuneresponse, recurrence and metastasis in breast cancer surgery: a prospective randomizedcontrol study

ICMR1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年6月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Non-occurrence of breast cancer at the end of 3-years

研究概览

简要总结

Breast cancer is increasingly becoming the most common cancer among females in India(25%–32% as per the National Cancer Registry). The breast cancer surgery is frequentlyassociated with postoperative pain, postoperative nausea and vomiting (PONV) which mayincrease suffering and prolong the hospital stay.Perioperative pain management can be provided by use of intravenous drugs (opioids,NSAIDS and paracetamol) which may lead to side effects like sedation, respiratorydepression, PONV, hypotension, bradycardia, pruritus et. Moreover, in recent years use ofopioids has been linked to influence cancer recurrence. Many regional anesthetic (RA) techniques have been used for breast surgeries; these includelocal wound infiltration, thoracic epidural anesthesia, thoracic paravertebral block, and morerecently, ultrasound (US)-guided interfacial plane blocks such as pectoral nerve block,serratus anterior plane block and erector spinae plane block. The beneficial effects of RAinclude decreased need for opioids for controlling post-operative pain, decreased PONV anddecreased duration of hospital stay. RA may also reduce cancer progression by attenuation ofthe surgical stress response and by the direct protective action of local anesthetics on cancercells migration. However, the beneficial effects of RA have been shown in a fewretrospective studies. Considering the magnitude of the disease and possible beneficial effectsof RA in our country, the results may be different than what we may get from ongoing trials.So, we want to conduct a prospective randomized control trial to show the effectiveness ofRA in biochemical and clinical recurrence in patients undergoing breast cancer surgeries. Women younger than 75 years of ASA physical status III or less with primary breastcancer limited to breast and axillary nodes (tumor stage 1-3 and nodes 0-2) schedulesfor unilateral mastectomy with or without nodal dissection and give consent willdivided into two groups:Group RA (regional analgesia group): Patients will receive US guided regional blockalong with general anesthesia (GA) using 10 cm (100 mm) needle.Group GA (general anesthesia group): Patients will standard GA technique. In the operation theatre, standard monitors will beattached and parameters will be recorded. Fentanyl-propofol-rocuronium based anesthetic technique will be used in all patients and airway will besecured using an appropriate size supraglottic airway. 2 ml of blood sample will be taken one day prior to surgery to know the baselinevalues of Neutrophil Lymphocyte Ratio (NLR), Platelet Lymphocyte Ratio (PLR),number of T helper cells, Natural Killer Cells (NKC) and cytotoxic T cells. The sameblood investigations will be repeated after patient is shifted to recovery room and after24 hours of surgery. The patients willbe followed at six-month interval for a period of 3 years to see for local or systemicrecurrence.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
Female

入选标准

  • ASA physical status III or less
  • Primary breast cancer for unimastectomy/breast conservation surgery
  • With or without lymph node dissection
  • Women younger than 75 years.

排除标准

  • age more than 75 years ASA status IV or more Patient refusal Coagulopathy Patients with history of allergy to study drugs.

结局指标

主要结局

Non-occurrence of breast cancer at the end of 3-years

时间窗: Patients will be examined every six months till three years to screen for local and systemic breast cancer recurrence by clinical assessment at the end of 3-years.

次要结局

  • 1. Biochemical recurrence(2. Persistent postoperative pain)

研究者

发起方
ICMR
申办方类型
Research institution

研究点 (1)

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