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Japanese

Dec. 26, 2024

Feb. 04, 2025

jRCTs052240226

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)

VALINOR study (VALINOR study)

Matsuura Hideki

Nara Medical University Hospital

840 Shijo-Cho, Kashihara, Nara

+81-744-29-8902

hmatsura0610@naramed-u.ac.jp

Matsuura Hideki

Nara Medical University Hospital

840 Shijo-Cho, Kashihara, Nara

+81-744-29-8902

hmatsura0610@naramed-u.ac.jp

Recruiting

Dec. 26, 2024

Jan. 15, 2025
84

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

supportive care

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

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

20age old over
85age old not

Male

Prostate cancer

1) Administration of lidocaine or saline solution
During the induction of anaesthesia, an initial dose equivalent to 1.5 mg/kg is administered over 10 minutes, followed by continuous administration at a maintenance dose of 1.5 mg/kg/h.
2) Change in the lower limit of anaesthetic administration flow rate in anaesthetic management protocols.
When the lower limit of the anaesthetic administration flow rate in the anaesthetic management protocol set in the NOLDOR study is used as it is (0.11 mcg/kg/min) and when the lower limit is lowered (0.05 mcg/kg/min).

Prostate cancer, Robot-assisted laparoscopic radical prostatectomy, intravenous lidocaine

Prostatic Neoplasms

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

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

Nara Medical University
Not applicable
Nara Medical University Certified Review Board
840 Shijo-cho Kashihara-shi, Nara

+81-744-29-8835

ethics_nara@naramed-u.ac.jp
Approval

Dec. 18, 2024

none

History of Changes

No Publication date
3 Feb. 04, 2025 (this page) Changes
2 Jan. 28, 2025 Detail Changes
1 Dec. 26, 2024 Detail