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临床试验/NCT03965442
NCT03965442Unknown不适用

Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome: a Cross-sectional Study

Hospital de Base1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
66
试验地点
1
主要终点
Incidence of post-mastectomy chronic pain syndrome

研究概览

简要总结

Chronic postoperative pain is an entity that is usually neglected by anesthetists, but several studies show that the choice of anesthetic technique may interfere with this prevalence. Esmolol is a selective beta-blocker of ultra fast duration that has been studied as a perioperative venous adjuvant with antihyperalgesic and opioid sparing action. The investigators ventured the possibility of this anti-hyperalgesic effect attenuating the chronic pain syndrome post-mastectomy.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients previously submitted to the study Analgesic Effect of Intraoperative Esmolol in Mastectomies: a randomized placebo controlled trial

排除标准

  • Patient aged less than 18 years and over 65 years;
  • Patients who refuse to participate in the study;
  • Patients with pulmonary disease;
  • Patients with cardiac, renal or hepatic disease;
  • Use of psychoactive drug;
  • Patients with sinus bradycardia;
  • Pregnant women;
  • Patients with allergy to dipyrone, morphine;
  • Patients with chronic pain prior to the surgical procedure;
  • Patients with neurological disorders;
  • Patients undergoing surgical resurfacing

研究组 & 干预措施

Control

Patients who underwent mastectomy under standard general anesthesia

Patients in placebo group received general balanced inhaled anesthesia with sevoflurane and remifentanil and a saline 0,9% infusion pump.

干预措施: Control (Drug)

Esmolol

Patients in esmolol group received general balanced inhaled anesthesia with sevoflurane and a bolus infection of esmolol 500 mgc/kg followed by a continuous infusion of esmolol 100 mcg/kg/min

干预措施: Esmolol (Drug)

结局指标

主要结局

Incidence of post-mastectomy chronic pain syndrome

时间窗: Through study completion, an average of 6 to 9 month

Incidence analysis using a questionnaire applied to patients in the late postoperative period.

次要结局

  • Stratify the possible types of pain(Through study completion, an average of 6 to 9 month)
  • Assess the intensity of pain: Pain Scores on the Visual Analog Scale(Through study completion, an average of 6 to 9 month)
  • Identify possible risk factors(Through study completion, an average of 6 to 9 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fabricio Tavares Mendonca

Preceptor correspondent for anesthesiology residency

Hospital de Base

研究点 (1)

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