Variation of the Neutrophil To Lymphocyte Ratio During Opioid-Free General Anesthesia Associated With Thoracic Wall Blocks Vs General Anesthesia, in Breast Cancer Quadrantectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- 24h NLR variation
研究概览
简要总结
The Neutrophil to Lymphocyte Ratio (NLR) is a frequently used biomarker of the systemic inflammatory response and is considered one of the most sensitive markers of inflammation. Many studies have documented the association between the use of opioid drugs in the acute phase -as it can be considered the use during general anesthesia- and the increase of the NLR value. Such increase could determine a temporary phase of immunodepression in the immediate post operative period with consequent increase of the inflammatory state.
This study intends to assess whether different anesthetic techniques can be associated with different variations of the intra-patient NLR value between pre- and post-surgery. Patient will be randomized to receive either local regional anesthesia protocols with thoracic wall blocks (PEC I and serratus plane block) associated with opioid-free general anesthesia (PECS + Opioid-free GA) or general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •First diagnosis of histologically confirmed breast cancer
- •Candidate to external quadrantectomy and axillary surgery (biopsy of the sentinel lymph node and possible axillary lymphadenectomy)
- •Able to provide adequate informed consent
- •With intact cognitive abilities
排除标准
- •Ongoing pregnancy
- •In therapy or in follow-up for other cancers at the time of the study
- •Concurrent therapy with opioids or other drugs, for chronic pain conditions related to cancer or other diseases
- •History of documented allergy or previous adverse reaction to local anesthetics
- •Documented history of anesthesiology related problems during previous surgical interventions or history of problems in airway management
- •Unable to comply to study protocol schedule for logistic or other reasons
- •Refusal to participate to the study (absence of signed informed consent)
研究组 & 干预措施
PECS + Opioid-free GA
Loco-regional anesthesia with PEC I and serratus plane block with an echoguided technique and opioid-free general anesthesia
干预措施: Midazolam (Drug)
PECS + Opioid-free GA
Loco-regional anesthesia with PEC I and serratus plane block with an echoguided technique and opioid-free general anesthesia
干预措施: PECS (Procedure)
PECS + Opioid-free GA
Loco-regional anesthesia with PEC I and serratus plane block with an echoguided technique and opioid-free general anesthesia
干预措施: Opioid-free general anesthesia (Procedure)
PECS + Opioid-free GA
Loco-regional anesthesia with PEC I and serratus plane block with an echoguided technique and opioid-free general anesthesia
干预措施: Postoperative analgesia (Procedure)
GA
General anesthesia
干预措施: Midazolam (Drug)
GA
General anesthesia
干预措施: General anesthesia (Procedure)
GA
General anesthesia
干预措施: Postoperative analgesia (Procedure)
结局指标
主要结局
24h NLR variation
时间窗: Pre-operative and at 24 hours after the end of surgery
Intra-patient variation of the NLR value between the pre-operative and the first post-operative day
次要结局
- 1h NLR variation(Pre-operative, 1 hour and 24 hours after the end of surgery)
- Opioid consumption(24 hours)
- Complication(until hospital discharge, an average of 48 hours)
- Chronic pain(3, 6 and 12 months after surgery)
- Change in the levels of circulating cytokines in the post-operative period (one hour and 24 hours after surgery), compared to the baseline pre-operative values, in the two arms(24 hours)