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VALINOR study

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052240226
Enrollment
84
Registered
2024-12-26
Start date
2025-01-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Sponsors

Matsuura Hideki
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Contacts

Public ContactHideki Matsuura

Nara Medical University Hospital

hmatsura0610@naramed-u.ac.jp+81-744-29-8902

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026