Urinary Catheterization As the Cause of Abnormal Reaction of Patient, or of Later Complication, Without Mention of Misadventure At Time of ProcedureNCT06585748
Lidocaine Spray Use on Patients Comfort in Undergoing Bladder Catheterization
An observational study of Urinary Catheterization As the Cause of Abnormal Reaction of Patient, or of Later Complication, Without Mention of Misadventure At Time of Procedure, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 92 years, men only
- Conditions the study is for
- Urinary Catheterization As the Cause of Abnormal Reaction of Patient, or of Later Complication, Without Mention of Misadventure At Time of Procedure
- What is being tested?
- Lidocaine spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 92 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
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.
-
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Ankara, 06170
Elif Çelikel, MD, +905058310158, drelifkaya@gmail.com
Ahmet Burak Erdem, Asosc. Prof., +905054957495, drabe0182@gmail.com
About this study
Official title: 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.
- Being tested
- Lidocaine spray, Placebo
- Keywords
- Bladder catheterization, Pain control, Lidocaine spray, Patient comfort
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine sprayDrug
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.
PlaceboOther
No medication/application will be administered as placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 0., 15., 30., and 60. minutes
Secondary outcomes (1)
Lidocaine and comfort
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 .
Measured: 0., 15., 30., and 60. minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start1 Jul 2022
- Primary completion1 Jul 2023
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Catheterization As the Cause of Abnormal Reaction of Patient, or of Later Complication, Without Mention of Misadventure At Time of ProcedureStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Kaya Çelikel, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585748
- Sponsor's protocol ID
- ACH-Lidocaine
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lidocaine Spray Use on Patients Comfort in Undergoing Bladder Catheterization: a Prospective,observational ,controlled Study
- ClinicalTrials.gov ID
- NCT06585748
- Acronym / sponsor ID
- ACH-Lidocaine
- Keywords
- Bladder catheterization, Pain control, Lidocaine spray, Patient comfort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L | – | Drug: Lidocaine sprayGroup 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. |
| Group P | – | Other: PlaceboGroup 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. |
Who may qualify
- Ages
- 18 to 92 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine spray4 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. | Drug | Group L |
| PlaceboNo medication/application will be administered as placebo. | Other | Group P |
Primary outcome
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 .
1 secondary outcome
Lidocaine and comfort
Time frame: 0., 15., 30., and 60. minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Catheterization As the Cause of Abnormal Reaction of Patient, or of Later Complication, Without Mention of Misadventure At Time of Procedure, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lidocaine and Pain (time frame: 0., 15., 30., and 60. minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.