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NCT Number: NCT06585748

Lidocaine Spray Use on Patients Comfort in Undergoing Bladder Catheterization

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.

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Key information

Conditions

Urinary Catheterization As the Cause of Abnormal Reaction of Patient, or of Later Complication, Without Mention of Misadventure At Time of Procedure Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–92 year

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The study included male patients over 18 years old, without trauma, with spontaneous urine output, and who were oriented and cooperative. -

Exclusion criteria

Exclusion criteria were patients under 18 years old, female patients, patients with trauma, patients with globe vesicale (due to the need for rapid bladder catheterization), patients with anatomical variations, patients with urethral-bladder outlet problems preventing catheterization, and patients who refused to participate in the study.

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Treatment and study plan

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.

Placebo

Other

No medication/application will be administered as placebo.

Primary outcomes

  1. Lidocaine and Pain

    Time frame: 0., 15., 30., and 60. minutes

    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 .

Secondary outcomes

  1. Lidocaine and comfort

    Time frame: 0., 15., 30., and 60. minutes

    Wong-Baker pain scale evaluates pain based solely on facial expressions. A score of 0 represents no pain, while a score of 10 represents unbearable pain .

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

The Effect of Lidocaine Spray Use on Patients Comfort in Undergoing Bladder Catheterization: a Prospective,observational ,controlled Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 5, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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