Effect of Intravenous Analgesic Lidocaine Based on Nociception Level-Directed management in Robot-assisted laparoscopic radical prostatectomy - a double-blinded Randomized Controlled Trial - (VALINOR study)

未提供0 个研究点目标入组 84 人开始时间: 2025年1月15日最近更新: 2025年2月4日

适应症

试验速览

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•Male patients undergoing scheduled robotic-assisted laparoscopic total prostatectomy
•Patients with American Society of Anaesthesiologists physical status classification1-3
•Age between 20 and 85 years
•Patients with written consent to participate in the study

•Patients who are scheduled to undergo urgent surgery
•Patients who are being treated with beta-blockers (oral intake or patch)
•Patients taking steroids
•Patients taking cimetidine
•Patients with a history of hypersensitivity to lidocaine
•Patients with severe conduction system disorders
•Patients with severe liver disorders (Child B or C)
•Patients with severe renal disorders (eGFR <30)
•Patients who are unable to secure the measurement site, e.g. after finger amputation or with nail lesions
•Patients who are incapable of consenting
•Patients who are judged to be inappropriate as research subjects by the (co-)investigators responsible for the study

NRS (Numerical Rating Scale) values during body movements at 2 hours postoperatively

Changes in biomarker values: IL-6(after anesthesia induction, at the end of surgery, postoperative day 1)
Changes in biomarker values: CRP(at anesthesia outpatient visit, postoperative day 1, postoperative day 3)
Changes in biomarker values: Cortisol(after anesthesia induction, at the end of surgery)
Total amount of remifentanil used during surgery(during surgery)
Changes in QoR-15 scores(day before surgery, postoperative days 1 and 2)
Pain scores (NRS values)(preoperatively, 2 hours after surgery, postoperative days 1, 2, 3, 7, and 3 months)
Perioperative consumption of narcotics (opioids) and analgesics(perioperative)
Presence or absence of prolonged postoperative pain at 3 months(3 months)

发起方

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