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NOLDOR study

Effect of NoL -Directed Analgesic management on opioid usage in Robot-assisted laparoscopic radical prostatectomy - a Randomized Controlled Trial - (NOLDOR study) - NOLDOR study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs052220034
Enrollment
54
Registered
2022-05-27
Start date
2022-07-19
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

Interventions

Use the analgesic protocol with a device not approved in Japan (PMD-200)

Sponsors

Tanaka Nobuhiro
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Male patients undergoing scheduled robot-assisted laparoscopic radical prostatectomy 2) Patients who were classed as American societyof anesthesiologists performance status (ASA-PS) 1-3 3) Patients aged between 20 and 85 years old 4) Patients who have given written consent to participate in the study

Exclusion criteria

Exclusion criteria: 1) Patients undergoing emergency surgery applied for the day 2) Patients taking beta-blockers, or applying patches for this drug 3) Patients taking oral steroids 4) Patients who cannot secure the measurement site due to a amputation of the finger or lesion on the nail 5) Patients with inability to give consent 6) Patients who have been judged inappropriate in the study by the investigator or sub-investigator

Design outcomes

Primary

MeasureTime frame
Amount of intraoperative remifentanil usage (Total amount of remifentanil divided by the usagetime (min) and ideal body weight (kg) )

Secondary

MeasureTime frame
1) Comparison of biomarker values (IL-6, CRP, cortisol) between the two groups 2) Changes in NoL values before and after events such as intubation, initiation of insufflation and re positioning in laparoscopic surgery 3) Numerical Rating Scale (NRS) values on the day of surgery (2 hours after surgery), 1, 2, 3, and 7 days after surgery, and 3 months after surgery 4) Perioperative opioid consumption 5) Presence of chronic postsurgical pain

Contacts

Public ContactNobuhiro Tanaka

Nara Medical University Hospital

nobuhirotanaka@naramed-u.ac.jp+81-744-22-3051

Outcome results

None listed

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