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临床试验/NCT02185859
NCT02185859已完成不适用

Effect of Perioperative Intravenous Lidocaine Infusion and Magnesium Infusion on the Functional Recovery After General Anesthesia in the Patients Undergoing Breast Mastectomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2014年7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
已完成
入组人数
126
试验地点
1
主要终点
The difference of QoR-40 global scores

研究概览

简要总结

Postsurgical pain is a relevant side effect following surgery which increases the risk of various complications and delays postoperative patient recovery. Among the many types of surgeries, mastectomy causes not only acute but also chronic pain in many patients. Therefore, it is important to control pain and increase patients' recovery satisfaction following many kinds of operations by using as small an opioid analgesic dose as possible and adding a nonopioid analgesic to reduce the side effects of narcotic analgesics. Among nonopioid analgesics, lidocaine and magnesium are drawing attention, having been shown to be helpful in controlling postoperative pain by lowering pain hypersensitivity to surgical stimuli. An intraoperative intravenous injection of lidocaine has been reported to improve postoperative pain control by reducing postoperative pain and opioid consumption. Another report showed that an intraoperative intravenous injection of lidocaine improved the quality of postoperative functional recovery after general anesthesia in a laparoscopic cholecystectomy patient. In addition, a review article on the effect of intraoperative intravenous injection of magnesium found it to be an effective analgesic that may be added to conventional opioid-based therapy because it generally reduces opioid consumption, decreases pain assessment for 24 hours after surgery, and lacks severe side effects in relation to magnesium administration. However, there has been insufficient research comparing the intraoperative intravenous injection of lidocaine or magnesium in terms of which is more helpful for general functional recovery and decreased postoperative pain. Recently, the scope of research on anesthesia has come to embrace postanesthetic recovery; to help patients return to daily life, the research trend is now shifting from the improvement or resolution of a specific symptom to the measurement of general recovery. A widely used method to measure postoperative recovery is the Quality of Recovery 40 (QoR-40) survey.

Therefore, in this study, the researchers investigated the intraoperative intravenous injection of lidocaine and the intravenous injection of magnesium to compare these drugs' helpfulness in the functional recovery of mastectomy patients after general anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Patients aged between 20 and 65 who have undergone mastectomy due to breast cancer and of American Society of Anesthesiologists (ASA) Physical Status Class 1 or Class 2

排除标准

  • Patients experiencing pain for any cause or taking an analgesic
  • Pregnant patients
  • Patients with severe heart, kidney, or liver disease
  • Patients with a psychiatric or neurological disorder
  • Patients with a contraindication or allergic response to lidocaine
  • Patients with a contraindication or allergic response to magnesium

研究组 & 干预措施

Perioperative lidocaine infusion

Experimental

干预措施: Lidocaine (Drug)

Perioperative magnesium infusion

Experimental

干预措施: Magnesium Sulfate (Drug)

Noraml saline infusion

Active Comparator

干预措施: Saline (Drug)

结局指标

主要结局

The difference of QoR-40 global scores

时间窗: 24 hours after mastectomy

The investigators will evaluate the quality of recovery after general anesthesia by considering the global score (200 points in total) of QoR-40 surveys, which is obtained by summing the subtotal scores for emotional status, physical comfort, psychological support, physical independence, and pain. The QoR-40 administered 24 hours after the operation is the primary endpoint of this research.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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