Lidocaine Spray Use on Patients Comfort in Undergoing Bladder Catheterization
September 4, 2024 updated by: Elif Kaya Çelikel, Ankara City Hospital Bilkent
The Effect of Lidocaine Spray Use on Patients Comfort in Undergoing Bladder Catheterization: a Prospective,observational ,controlled Study
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.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Estimated)
100
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
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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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 .
|
0., 15., 30., and 60. minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 .
|
0., 15., 30., and 60. minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
July 1, 2023
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
August 28, 2024
First Submitted That Met QC Criteria
September 4, 2024
First Posted (Estimated)
September 5, 2024
Study Record Updates
Last Update Posted (Estimated)
September 5, 2024
Last Update Submitted That Met QC Criteria
September 4, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- ACH-Lidocaine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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