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临床试验/NCT07359469
NCT07359469已完成不适用

Evaluation of Intraoperative Intravenous Lidocaine, Ketamine, and Magnesium on Postoperative Pain and Opioid Use After Pulmonary Resection: A Prospective Observational Cohort Study

Universidad Pública de Navarra0 个研究点目标入组 118 人开始时间: 2018年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
118

研究概览

简要总结

Thoracic surgery often produces severe postoperative pain due to nerve injury and inflammation. Effective pain control is essential to reduce complications and opioid use. This prospective observational cohort study evaluated adult patients undergoing pulmonary resection by thoracotomy or video-assisted thoracoscopic surgery (VATS). The study examined whether intraoperative administration of intravenous lidocaine, ketamine, and magnesium, used as part of multimodal analgesia, was associated with reduced postoperative morphine consumption and lower early postoperative pain scores. Outcomes included 24-hour morphine use, pain intensity at 3 and 24 hours, complications, and chronic pain at 3 months. No study-directed interventions were performed; anesthetic management followed routine clinical practice.

详细描述

This prospective observational cohort study included 118 adult patients undergoing elective pulmonary resection between 2018 and 2022. The objective was to evaluate the association between intraoperative intravenous lidocaine, ketamine, and magnesium (LKM) and postoperative analgesic outcomes. Seventy-one patients received intraoperative LKM as part of a standardized multimodal analgesic protocol, consisting of lidocaine (1.5 mg/kg bolus followed by 1.5 mg/kg/h infusion), ketamine (0.3 mg/kg bolus), and magnesium sulfate (1.5 g bolus). Forty-seven patients received standard anesthesia without LKM administration. No study-specific interventions were assigned; exposure was based on routine anesthetic practice.

The primary outcome was total intravenous morphine consumption during the first 24 postoperative hours. Secondary outcomes included pain scores (VAS) at 3 and 24 hours, incidence of chronic postoperative pain at 3 months, pulmonary and cardiovascular complications, renal injury, thromboembolic events, hospital length of stay, and mortality. Safety monitoring included hypotension, bradycardia, arrhythmias, hallucinations, and delayed emergence from anesthesia.

This study aimed to identify perioperative factors influencing postoperative pain and opioid use after thoracic surgery, while evaluating the potential benefit of LKM within a multimodal analgesia strategy. All patients provided informed consent, and the study was approved by the local ethics committee. Data collection and clinical management followed standard institutional protocols.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Adults aged 18 years or older.
  • Scheduled for elective pulmonary resection (thoracotomy or VATS).
  • Able to provide informed consent.
  • ASA physical status I-IV.

排除标准

  • Emergency surgery.
  • Known allergy or contraindication to lidocaine, ketamine, or magnesium.
  • Severe hepatic insufficiency.
  • Severe renal dysfunction (eGFR < 30 mL/min/1.73 m²).
  • Pre-existing significant arrhythmias (e.g., uncontrolled atrial fibrillation, ventricular arrhythmias).
  • Pregnancy.
  • Cognitive impairment preventing valid informed consent.
  • Patients receiving chronic intravenous analgesics or regional anesthesia techniques preoperatively.

研究者

申办方类型
Other
责任方
Sponsor

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