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Randomized blind group comparison test on urinary catheter discomfort alleviation effect by xylocaine concentration when urinary catheter with lumen for medical solution administration is used

Randomized blind group comparison test on urinary catheter discomfort alleviation effect by xylocaine concentration when urinary catheter with lumen for medical solution administration is used - Randomized blind group comparison trial of reduction of urethral discomfort by NMOC catheter

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027008
Enrollment
90
Registered
2017-04-17
Start date
2016-11-17
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

Patient planned to use a urethral catheter at the perioperative period

Interventions

It is classified into three groups with chemical liquid injected from the side tube of NMOC-3 WAY catheter. Saline solution (Placebo) 5 ml It is classified into three groups with chemical liquid inje

Sponsors

National Hospital Organization Fukuyama Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Patients who undergo general anesthesia without epidural anesthesia for surgery of gastrointestinal surgery, orthopedic surgery, urology, respiratory surgery. Male patient who intends to place a urinary catheter. Patients whose age at registration is 20 years or older. Patients who are class 1 (normal health patients) or class 2 (patients with mild systemic diseases and whose daily activities are restricted) in the ASA-PS (ASA physical status) classification. Patients who have written consent for this study.

Exclusion criteria

Exclusion criteria: Patients who undergo urethral surgery. Patients with a history of hypersensitivity to xylocaine or amide type local anesthetic. Patients who have suffered a feeling after having undergone surface anesthesia in dental practice. Persons who can bear arrhythmia on the electrocardiogram or patients taking oral antiarrhythmic drugs. Patient who has consciousness disorder or who has difficulty communicating and may not obtain a valid evaluation. Patients with moderate renal failure or liver failure. Patients who underwent epidural anesthesia. Patients taking opioid analgesics. Patients who have difficulty communicating after surgery. Patients with delirium and delirium treatment medicine. Emergency operation. Patients who did not obtain consent to this study.

Design outcomes

Primary

MeasureTime frame
VAS scale of urinary catheter discomfort before exiting the operating room and before bedtime on the day of surgery. VAS scale of wound pain before exit from the operating room and before bedtime on the day of surgery.

Secondary

MeasureTime frame
CAM-ICU score of delirium on the night of surgery, general state before surgery, surgical invasion, changes in vital signs during and after surgery

Countries

Japan

Contacts

Public ContactSuita koukyou

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences

passkey55555@gmail.com086-235-7778

Outcome results

None listed

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