Lidocaine Spray Use on Patients Comfort in Undergoing Bladder Catheterization

NCT06585748 | Recruiting

• 1 other identifier: ACH-Lidocaine
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Bladder catheterization is a procedure frequently performed in emergency departments and may cause symptoms such as pain and discomfort in patients. This study hypothesizes that lidocaine spray application will improve patient compliance and comfort from the outset and facilitate smoother medical procedures. In our prospective, case-controlled study, the patients were divided into two groups: Group L (lidocaine) and Group P (placebo). Pain conditions after bladder catheterization were evaluated at 0 minutes (during the procedure) and 15, 30 and 60 minutes after the procedure. Face Legs Arm Cry Consolability Pain Scale (FLACC) and Wong-Baker pain scales were used. All time periods in Group L, FLACC score and Wang Baker scores were found to be statistically significantly lower.The differences between the first measurement and the measurements at 15-30-60 minutes of the FLACC score were found to be significantly higher in group P than in group L. As a result, we recommend that lidocaine spray be applied before urinary catheter insertion. This study showed that lidocaine spray increased patients\' sleep at the end and reduced the feeling of restlessness by reducing pain.

Conditions

Urinary Catheterization As the Cause of Abnormal Reaction of Patient, or of Later Complication, Without Mention of Misadventure At Time of Procedure

Keywords

Bladder catheterization; Pain control; Lidocaine spray; Patient comfort

Outcome Measures

Primary Outcomes (1)

• Lidocaine and Pain

  The FLACC scale assesses acute pain based on facial expression, leg position, activity, crying, and consolability Each category is scored from 0-2, with 0 indicating a calm patient and 10 indicating a visibly distressed patient .

  0., 15., 30., and 60. minutes

Secondary Outcomes (1)

• Lidocaine and comfort

  0., 15., 30., and 60. minutes

Study Arms (2)

Group L

Group L: Lidocaine spray. Lidocaine spray in our country is available in a 10% spray form, with each puff containing 10 mg of lidocaine. In Group L, 4 puffs of lidocaine spray were applied to the glans penis and urethral meatus, and after 5 minutes, the appropriate method and sterilization were used to apply a catheter gel, and a Foley catheter was placed in the bladder.

Drug: Lidocaine spray

Group P

Group P: Placebo In Group P, 4 puffs of isotonic saline (%0.09 NaCl) spray were applied to the glans penis and urethral meatus, followed by catheter gel application and Foley catheter placement.

Other: Placebo

Interventions

Lidocaine spray DRUG

4 puffs of lidocaine spray was applied to the glans penis and urethral meatus, and after 5 minutes, the appropriate method and sterilization were used to apply a catheter gel, and a Foley catheter was placed in the bladder. After bladder catheterization, pain scores were evaluated by a neutral emergency medicine physician at 0 minutes (during the procedure), and at 15, 30, and 60 minutes post-procedure. The Face Legs Arms Cry Consolability Pain Scale (FLACC) and Wong-Baker pain scales were used for this evaluation.

Group L

Placebo OTHER

No medication/application will be administered as placebo.

Group P

Eligibility Criteria

• Age: 18 Years - 92 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of patients who required bladder catheterization during the follow-up and treatment process and came to the emergency departments of two major city hospitals in Ankara.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Ankara, 06170, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 5, 2024
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)