跳至主要内容
临床试验/NCT02647385
NCT02647385进行中(未招募)不适用

Pain Control in Breast Surgery: Analgesia, Opioid Consumption and Inflammatory Response Evaluation

Hospital Sirio-Libanes1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
1
主要终点
Patient´s Pain assessment

研究概览

简要总结

The serratus anterior muscle plane (SAM) block associated with pectoral nerve block type I (PEC I) may be a safe and effective alternative for the intraoperative of breast surgery, since there is evidence of pain reduction. However, correlation between regional anesthesia, postoperative pain and inflammatory response in breast surgery has not been demonstrated. The aim of this study is to compare the standard intravenous analgesia versus systemic analgesia associated with the SAM block and PEC I during breath cancer surgery. The following parameters will be evaluated: consumption of opioid intra and post-operative; post-operative pain and release of plasma inflammatory cytokines. It is a clinical prospective, randomized and controlled study. 50 individuals will be randomly divided into two groups. A group of patients receive general anesthesia during surgery and intravenous analgesia after the surgery and another group will receive general anesthesia associated with SAM and PEC I block during intraoperative and postoperative systemic analgesia. The postoperative pain will be assessed using the Visual Analogue Scale pain in the recovery room and 24 hours after surgery. Blood sample will be collected for determination of serum cytokines before surgery and 24 hours after the surgery. Also, it will be evaluated the development of chronic neuropathic pain 12 months after mastectomy, the use of analgesic medication, quality of life, depressive symptoms, and the levels of interleukin (IL)-1 beta, IL-6, and IL-10 as predictors of pain and depression.

详细描述

In breast surgery, regional anesthesia associated with general anesthesia during surgery has shown great results for the post-operative pain management, prevention of tumor recurrence and development of neuropathic pain. It has been shown that regional anesthesia attenuates the inflammatory response and systemic changes postoperatively during breast surgeries. Thus, it is important to include an additional analgesic intervention in breast surgery in order to decrease the local inflammatory response and the postoperative pain. Thus, the serratus anterior muscle plane (SAM) block associated with pectoral nerve block type I (PEC I) may be a safe and effective alternative for the intraoperative of breast surgery, since there is evidence of pain reduction. However, correlation between regional anesthesia, postoperative pain and inflammatory response in breast surgery has not been demonstrated. The aim of this study is to compare the standard intravenous analgesia versus systemic analgesia associated with the SAM block and PEC I during breath cancer surgery. The following parameters will be evaluated: consumption of opioid intra and post-operative; post-operative pain and release of plasma inflammatory cytokines. It is a clinical prospective, randomized and controlled study. Also, it will be evaluated the development of chronic neuropathic pain 12 months after mastectomy, the use of analgesic medication, quality of life, depressive symptoms, and the levels of interleukin (IL)-1 beta, IL-6, and IL-10 as predictors of pain and depression. 50 individuals will be randomly divided into two groups. A group of patients receive general anesthesia during surgery and intravenous analgesia after the surgery and another group will receive general anesthesia associated with SAM and PEC I block during intraoperative and postoperative systemic analgesia. The postoperative pain will be assessed using the Visual Analogue Scale pain in the recovery room and 24 hours after surgery. Blood sample will be collected for determination of serum cytokines before surgery and 24 hours after the surgery.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society Anesthesiology (ASA) Scale I and II patients
  • Patients submitted to breast cancer
  • informed consent signature

排除标准

  • Patients with chronic pain
  • Local anesthesia reaction/allergy

研究组 & 干预措施

General Anesthesia

Experimental

Interventions: include pain assessment, inflammatory response and opioid consumption.

干预措施: Block with lidocaine for SAM and PEC I block (Drug)

General Anesthesia SAM and PEC I block

Experimental

Interventions: include pain assessment, inflammatory response and opioid consumption.

干预措施: Block with lidocaine for SAM and PEC I block (Drug)

结局指标

主要结局

Patient´s Pain assessment

时间窗: 24 hours

The postoperative pain will be assessed using the Visual Analogue Scale pain in the recovery room and 24 hours after surgery.

次要结局

  • Opioid consumption(24 hours)
  • Cytokines(24 hours)
  • Development of chronic pain(1 year)

研究者

发起方
Hospital Sirio-Libanes
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raquel Chacon Ruiz Martinez

MS, PhD

Hospital Sirio-Libanes

研究点 (1)

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