PainPhase 3No needNCT07242157
Effects of Topical Lidocaine and Benzocaine on Pain Level and Injection Satisfaction
A Phase 3 study testing Lidocaine Spray: Each ml contained 10 mg lidocaine and ethanol. Applied to the local site to provide anesthesia and Benzocaine spray in people with Pain and Satisfaction, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effectiveness of topical lidocaine and benzocaine in reducing pain and improving injection satisfaction during Arteriovenous Fistula (AVF) catheterization among hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Satisfaction, Hemodialysis
- What is being tested?
- Lidocaine Spray: Each ml contained 10 mg lidocaine and ethanol. Applied to the local site to provide anesthesia and Benzocaine spray
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Jun 2024
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years,
- non-pregnant, not planning pregnancy,
- receiving hemodialysis three times weekly for at least three months,
- continuously treated at the same institution without any change in treatment regimen,
- without pain in any part of the body affecting study outcomes,
- with a Visual Analog Scale (VAS) pain score of zero at baseline,
Show all 12Show fewer
- no analgesics within 24 hours prior,
- a baseline Algometer pressure pain threshold of 8-16 lbs.
- participants were required to understand Turkish,
- communicate effectively,
- volunteer for the study, and
- provide written informed consent.
Who cannot join
- Individuals with neurological disorders such as epilepsy, Alzheimer's disease, Parkinson's disease, or multiple sclerosis,
- unable or unwilling to comply with study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Topical Lidocaine and Benzocaine on Pain Level and Injection Satisfaction.
This study aimed to evaluate the effectiveness of topical lidocaine and benzocaine in reducing pain and improving injection satisfaction during Arteriovenous Fistula (AVF) catheterization among hemodialysis patients.
Design:A randomized controlled trial was conducted with 60 hemodialysis patients who met the inclusion criteria.
Methods: Participants were randomly assigned into three groups: Lidocaine Spray (n=20), Benzocaine Spray (n=20), and Placebo (n=20). Pain intensity and injection satisfaction were measured immediately after catheterization using the Visual Analogue Scale (VAS) and the Injection Satisfaction Scale (ISS).
Read the detailed description
All individuals included in the study were provided with private health insurance to cover any potential adverse events resulting from the procedure. The participants were informed about the study both verbally and in writing, and written informed consent forms were obtained from them. Individuals who met the inclusion criteria and signed the informed consent form were assigned to study groups according to a computer-generated randomization list based on their file numbers. Accordingly, the first group was designated as the Lidocaine Spray group (Experiment I), the second group as the Benzocaine Spray group (Experiment II), and the third group as the placebo group. The design of the study, including the formation of the groups and the implementation process, is presented in Figure 3.
Two nurses working in the hemodialysis unit volunteered to participate in the study and received training from the researcher regarding the study procedures. To eliminate individual differences, one nurse performed the Arteriovenous Fistula (AVF) catheterization, while the other collected the data. These nurses were blinded to the group assignments of the patients they intervened with. In addition, the participants themselves were unaware of the groups to which they were assigned according to computer randomization. The individuals were informed about the Visual Analog Scale and the Injection Satisfaction Evaluation Scale. The nurse responsible for data collection measured and recorded in the Case Report Form the blood pressure, pulse rate, and peripheral oxygen saturation (using a fingertip pulse oximeter) five minutes before and immediately after the procedure. Blood pressure measurements were taken from the arm opposite to the Arteriovenous Fistula (AVF) catheterization site using a calibrated digital sphygmomanometer.
Since the Lidocaine Spray and Benzocaine Spray used in the groups had similar-looking bottles, the medications were used in their original containers. For the placebo group, a Lidocaine Spray bottle was emptied, washed, and sterilized in an autoclave. The sterilized glass bottle was then filled with 70% alcohol routinely used in the hospital. Subsequently, the bottles were labeled by the researchers with color-coded bands on their bases: red for the Lidocaine Spray, blue for the Benzocaine Spray, and black for the alcohol (Figure 2). The content of each bottle was identified only by the color band on its base, known exclusively to the researchers.
To prevent errors due to catheter differences, all patients included in the study received AVF catheters. To enhance the reliability of the study and avoid variations in pain levels, the same arterial and venous catheters were used for all AVF procedures. Immediately after AVF catheterization, the patient's blood pressure, pulse rate, and peripheral oxygen saturation were measured using a fingertip pulse oximeter, and the pain intensity experienced during the procedure was recorded by the nurse on the Questionnaire Form using the Visual Analog Scale (VAS) and Injection Satisfaction Evaluation Scale (ISES) values.
- Conditions
- Pain, Satisfaction, Hemodialysis, Arteriovenous Fistula
- Being tested
- Lidocaine Spray: Each ml contained 10 mg lidocaine and ethanol. Applied to the local site to provide anesthesia, Benzocaine spray, Placebo group (control arm)
- Keywords
- pain, satisfaction, hemodialysis
- Medical subject headings
- Pain, Personal Satisfaction, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine Spray: Each ml contained 10 mg lidocaine and ethanol. Applied to the local site to provide anesthesiaDrug
In this study, a moderate, negative, and significant correlation was found between total pain scores and injection satisfaction scores in the lidocaine and benzocaine groups. Overall, evidence suggests that considering the positive effects of topical lidocaine and benzocaine on pain and satisfaction during invasive procedures represents an important step toward improving patient-centered care and satisfaction. Incorporating these interventions into clinical protocols in hemodialysis units could serve as a comfort-enhancing approach before dialysis procedures.
Benzocaine sprayDrug
This study, designed to investigate the effects of lidocaine and benzocaine on reducing pain and increasing injection satisfaction during AVF catheterization, is the first of its kind conducted in Türkiye. It is expected to make a significant contribution to nursing science and provide an effective approach for nurses to reduce catheter-related pain in hemodialysis units. Nurses play a vital role in minimizing procedure-related pain, and it is essential that they possess and apply knowledge about evidence-based, easy-to-use pharmacological methods to achieve this goal.
Placebo group (control arm)Drug
Lidocaine and benzocaine sprays were provided in identical bottles with color-coded bases to maintain blinding. All participants received AVF catheterization using the same arterial and venous sites to standardize procedure-related pain. Pain (VAS) and injection satisfaction (ISS) scores were recorded immediately after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Group II : Benzocain Sprey | Experimental | Benzocain Spray was applied to Experiment I group before AVF catheterization application Receives: Drug: Benzocaine spray |
| Group III: Placebo | Placebo comparator | Alcohol was administered to the placebo group prior to AVF catheterization application. Receives: Drug: Placebo group (control arm) |
| Group 1:Lidocaine spray | Experimental | Each ml contained 10 mg lidocaine and ethanol Receives: Drug: Lidocaine Spray: Each ml contained 10 mg lidocaine and ethanol. Applied to the local site to provide anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level (Visual Anolog Scale)
The Visual Analog Scale (VAS) is a widely used, subjective measurement tool designed to assess the intensity of pain or other symptoms that cannot be directly quantified. It typically consists of a 10-cm horizontal line with two anchor points at each end, representing the extremes of the symptom being measured-commonly "no pain" (0 cm) and "worst imaginable pain" (10 cm). Participants are asked to mark a point on the line that best reflects the severity of their current experience.
The distance (in centimeters or millimeters) between the left anchor and the participant's mark is measured to obtain the VAS score. Higher scores indicate greater symptom intensity. The VAS is considered a reliable and valid instrument due to its simplicity, sensitivity to change, and ability to capture nuanced variations in subjective experiences. It is frequently used in clinical and research settings, particularly in pain assessment, postoperative evaluation, and intervention studies.
Measured: Evaluation was made immediately after application
Secondary outcomes (1)
Injection Satisfaction Scale
The Injection Satisfaction Scale is a standardized instrument used to evaluate an individual's level of satisfaction with injection-related procedures. The scale assesses multiple dimensions of the injection experience, including perceived comfort during the injection, ease of administration, overall acceptability, and the individual's willingness to undergo the same procedure again. It is typically administered immediately after the injection to minimize recall bias.
Items on the scale are rated using a Likert-type response format, with higher scores indicating greater satisfaction. The scale has been shown to be a reliable and valid measure for assessing patient-reported outcomes related to injection procedures across various clinical and research settings. Its use allows for a comprehensive evaluation of patient satisfaction, facilitating comparisons between different injection techniques, devices, or interventions.
Measured: Evaluation was made immediately after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Apr 2024
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The study population consisted of patients receiving treatment at the hemodialysis unit of a university-affiliated dialysis hospital between the study period (N = 126). Among these, 60 individuals who met the inclusion criteria and were selected using a computer-generated randomization list comprised the study sample. Sample size calculation was performed using pre-analysis data from similar studies in G\*Power 3.1.9.2, assuming a 5% Type I error and 95% power, with a 39.5% difference in pain levels considered. Each study group was determined to include 18 participants
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevil Şahin, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242157
- Sponsor's protocol ID
- 2023/686
- Acronym
- No need
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- 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 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Lidocaine and Benzocaine on Pain Level and Injection Satisfaction.
- ClinicalTrials.gov ID
- NCT07242157
- Acronym / sponsor ID
- No need / 2023/686
- Conditions
- Pain, Satisfaction, Hemodialysis, Arteriovenous Fistula
- Keywords
- pain, satisfaction, hemodialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 21 Nov 2025 (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.
This study aimed to evaluate the effectiveness of topical lidocaine and benzocaine in reducing pain and improving injection satisfaction during Arteriovenous Fistula (AVF) catheterization among hemodialysis patients.
Design:A randomized controlled trial was conducted with 60 hemodialysis patients who met the inclusion criteria.
Methods: Participants were randomly assigned into three groups: Lidocaine Spray (n=20), Benzocaine Spray (n=20), and Placebo (n=20). Pain intensity and injection satisfaction were measured immediately after catheterization using the Visual Analogue Scale (VAS) and the Injection Satisfaction Scale (ISS).
Detailed description
All individuals included in the study were provided with private health insurance to cover any potential adverse events resulting from the procedure. The participants were informed about the study both verbally and in writing, and written informed consent forms were obtained from them. Individuals who met the inclusion criteria and signed the informed consent form were assigned to study groups according to a computer-generated randomization list based on their file numbers. Accordingly, the first group was designated as the Lidocaine Spray group (Experiment I), the second group as the Benzocaine Spray group (Experiment II), and the third group as the placebo group. The design of the study, including the formation of the groups and the implementation process, is presented in Figure 3.
Two nurses working in the hemodialysis unit volunteered to participate in the study and received training from the researcher regarding the study procedures. To eliminate individual differences, one nurse performed the Arteriovenous Fistula (AVF) catheterization, while the other collected the data. These nurses were blinded to the group assignments of the patients they intervened with. In addition, the participants themselves were unaware of the groups to which they were assigned according to computer randomization. The individuals were informed about the Visual Analog Scale and the Injection Satisfaction Evaluation Scale. The nurse responsible for data collection measured and recorded in the Case Report Form the blood pressure, pulse rate, and peripheral oxygen saturation (using a fingertip pulse oximeter) five minutes before and immediately after the procedure. Blood pressure measurements were taken from the arm opposite to the Arteriovenous Fistula (AVF) catheterization site using a calibrated digital sphygmomanometer.
Since the Lidocaine Spray and Benzocaine Spray used in the groups had similar-looking bottles, the medications were used in their original containers. For the placebo group, a Lidocaine Spray bottle was emptied, washed, and sterilized in an autoclave. The sterilized glass bottle was then filled with 70% alcohol routinely used in the hospital. Subsequently, the bottles were labeled by the researchers with color-coded bands on their bases: red for the Lidocaine Spray, blue for the Benzocaine Spray, and black for the alcohol (Figure 2). The content of each bottle was identified only by the color band on its base, known exclusively to the researchers.
To prevent errors due to catheter differences, all patients included in the study received AVF catheters. To enhance the reliability of the study and avoid variations in pain levels, the same arterial and venous catheters were used for all AVF procedures. Immediately after AVF catheterization, the patient's blood pressure, pulse rate, and peripheral oxygen saturation were measured using a fingertip pulse oximeter, and the pain intensity experienced during the procedure was recorded by the nurse on the Questionnaire Form using the Visual Analog Scale (VAS) and Injection Satisfaction Evaluation Scale (ISES) values.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The study population consisted of patients receiving treatment at the hemodialysis unit of a university-affiliated dialysis hospital between the study period (N = 126). Among these, 60 individuals who met the inclusion criteria and were selected using a computer-generated randomization list comprised the study sample. Sample size calculation was performed using pre-analysis data from similar studies in G*Power 3.1.9.2, assuming a 5% Type I error and 95% power, with a 39.5% difference in pain levels considered. Each study group was determined to include 18 participants
| Arm | Type | Receives |
|---|---|---|
| Group II : Benzocain Sprey | Experimental | Drug: Benzocaine sprayBenzocain Spray was applied to Experiment I group before AVF catheterization application |
| Group III: Placebo | Placebo comparator | Drug: Placebo group (control arm)Alcohol was administered to the placebo group prior to AVF catheterization application. |
| Group 1:Lidocaine spray | Experimental | Drug: Lidocaine Spray: Each ml contained 10 mg lidocaine and ethanol. Applied to the local site to provide anesthesiaEach ml contained 10 mg lidocaine and ethanol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients aged ≥18 years,
- non-pregnant, not planning pregnancy,
- receiving hemodialysis three times weekly for at least three months,
- continuously treated at the same institution without any change in treatment regimen,
- without pain in any part of the body affecting study outcomes,
Key exclusion criteria (2 listed)
- Individuals with neurological disorders such as epilepsy, Alzheimer's disease, Parkinson's disease, or multiple sclerosis,
- unable or unwilling to comply with study protocol.
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 Spray: Each ml contained 10 mg lidocaine and ethanol. Applied to the local site to provide anesthesiaIn this study, a moderate, negative, and significant correlation was found between total pain scores and injection satisfaction scores in the lidocaine and benzocaine groups. Overall, evidence suggests that considering the positive effects of topical lidocaine and benzocaine on pain and satisfaction during invasive procedures represents an important step toward improving patient-centered care and satisfaction. Incorporating these interventions into clinical protocols in hemodialysis units could serve as a comfort-enhancing approach before dialysis procedures. | Drug | Group 1:Lidocaine spray |
| Benzocaine sprayThis study, designed to investigate the effects of lidocaine and benzocaine on reducing pain and increasing injection satisfaction during AVF catheterization, is the first of its kind conducted in Türkiye. It is expected to make a significant contribution to nursing science and provide an effective approach for nurses to reduce catheter-related pain in hemodialysis units. Nurses play a vital role in minimizing procedure-related pain, and it is essential that they possess and apply knowledge about evidence-based, easy-to-use pharmacological methods to achieve this goal. | Drug | Group II : Benzocain Sprey |
| Placebo group (control arm)Lidocaine and benzocaine sprays were provided in identical bottles with color-coded bases to maintain blinding. All participants received AVF catheterization using the same arterial and venous sites to standardize procedure-related pain. Pain (VAS) and injection satisfaction (ISS) scores were recorded immediately after the procedure. | Drug | Group III: Placebo |
Primary outcome
Pain level (Visual Anolog Scale)
Time frame: Evaluation was made immediately after application
The Visual Analog Scale (VAS) is a widely used, subjective measurement tool designed to assess the intensity of pain or other symptoms that cannot be directly quantified. It typically consists of a 10-cm horizontal line with two anchor points at each end, representing the extremes of the symptom being measured-commonly "no pain" (0 cm) and "worst imaginable pain" (10 cm). Participants are asked to mark a point on the line that best reflects the severity of their current experience. The distance (in centimeters or millimeters) between the left anchor and the participant's mark is measured to obtain the VAS score. Higher scores indicate greater symptom intensity. The VAS is considered a reliable and valid instrument due to its simplicity, sensitivity to change, and ability to capture nuanced variations in subjective experiences. It is frequently used in clinical and research settings, particularly in pain assessment, postoperative evaluation, and intervention studies.
1 secondary outcome
Injection Satisfaction Scale
Time frame: Evaluation was made immediately after application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine Spray: Each ml contained 10 mg lidocaine and ethanol. Applied to the local site to provide anesthesia and Benzocaine spray in people with Pain and Satisfaction, run by TC Erciyes University 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?
The sponsor lists 12 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 1 Dec 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (Visual Anolog Scale) (time frame: Evaluation was made immediately after application). 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 1 Dec 2025.