VALINOR study (VALINOR study)
Recruiting
- Conditions
- Prostate cancer
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 84
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - NRS (Numerical Rating Scale) values during body movements at 2 hours postoperatively
- Secondary Outcome Measures
Name Time Method Changes in biomarker values: CRP at anesthesia outpatient visit, postoperative day 1, postoperative day 3 CRP (at anesthesia outpatient visit, postoperative day 1, postoperative day 3)
Changes in biomarker values: Cortisol after anesthesia induction, at the end of surgery Cortisol (after anesthesia induction, at the end of surgery)
Total amount of remifentanil used during surgery during surgery Total amount of remifentanil used during surgery
Changes in QoR-15 scores day before surgery, postoperative days 1 and 2 Changes in QoR-15 scores on the day before surgery and postoperative days 1 and 2
Pain scores (NRS values) preoperatively, 2 hours after surgery, postoperative days 1, 2, 3, 7, and 3 months Pain scores (NRS values) at rest preoperatively, 2 hours after surgery, and on postoperative days 1, 2, 3, 7, and 3 months
Perioperative consumption of narcotics (opioids) and analgesics perioperative Perioperative consumption of narcotics (opioids) and analgesics
Presence or absence of prolonged postoperative pain at 3 months 3 months Presence or absence of prolonged postoperative pain at 3 months
Changes in biomarker values: IL-6 after anesthesia induction, at the end of surgery, postoperative day 1 IL-6 (after anesthesia induction, at the end of surgery, postoperative day 1)