The Effect of Nefopam on Catheter-related Bladder Discomfort

The Effect of Nefopam on Catheter-related Bladder Discomfort: A Double-blind, Randomized, Controlled, Parallel Design Study

In the present study, the investigators evaluated whether nefopam 20 mg reduce the catheter-related bladder discomfort in patients undergoing foley catheter insertion

Study Overview

• Status: Completed
• Conditions: Nefopam; Catheter-related Bladder Discomfort
• Intervention / Treatment: Drug: Nefopam or saline

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National Univ. Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Patients scheduled to insert the catheter a new foley catheter more than 14 Fr in the operation site,
2. Adults 20 to 75years of age
3. American Society of Anesthesiologists Physical Classification 1,2 patients
4. Patients who pre-agreed to the study
5. Male patient

Exclusion Criteria:

1. Neurogenic bladder
2. Patients diagnosed with irritable bladder
3. study drug sensitive or contraindicated
4. Patients with central nervous system or neurological disorder (epilepsy, patients receiving MAO inhibitor)
5. Patients with urethral and prostate disorders
6. Patients with previous history of myocardial infarction
7. Patients with closed angle glaucoma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: The control group; One hour before the end of the operation, the control group was received 20 ml of saline.	Drug: Nefopam or saline; One hour before the end of the operation, the Nefopam group was received 20 mg of nefopam and the saline and the control group was received 20 ml of saline.
Active Comparator: The Nefopam group; One hour before the end of the operation, the Nefopam group was received 20 mg of nefopam.	Drug: Nefopam or saline; One hour before the end of the operation, the Nefopam group was received 20 mg of nefopam and the saline and the control group was received 20 ml of saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
catheter-related bladder discomfort	assessment of catheter-related bladder discomfort using visual analogue scale	postoperative 1 hour

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Eunsu Choi, pf, Seoul National Univ. Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: April 23, 2017
• First Submitted That Met QC Criteria: April 23, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Nefopam
• Other Study ID Numbers: B-1604/342-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No