Effects of Topical Lidocaine and Benzocaine on Pain Level and Injection Satisfaction

NCT07242157 | Completed Phase 3

• 1 other identifier: 2023/686
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Pain; Satisfaction; Hemodialysis; Arteriovenous Fistula

Keywords

pain; satisfaction; hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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.

  Evaluation was made immediately after application

Secondary Outcomes (1)

• Injection Satisfaction Scale

  Evaluation was made immediately after application

Study Arms (3)

Group II : Benzocain Sprey

EXPERIMENTAL

Benzocain Spray was applied to Experiment I group before AVF catheterization application

Drug: Benzocaine spray

Group III: Placebo

PLACEBO COMPARATOR

Alcohol was administered to the placebo group prior to AVF catheterization application.

Drug: Placebo group (control arm)

Group 1:Lidocaine spray

EXPERIMENTAL

Each ml contained 10 mg lidocaine and ethanol

Drug: Lidocaine Spray: Each ml contained 10 mg lidocaine and ethanol. Applied to the local site to provide anesthesia

Interventions

Lidocaine Spray: Each ml contained 10 mg lidocaine and ethanol. Applied to the local site to provide anesthesia DRUG

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.

Group 1:Lidocaine spray

Benzocaine spray DRUG

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.

Group II : Benzocain Sprey

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.

Group III: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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.

You may not qualify if:

• Individuals with neurological disorders such as epilepsy, Alzheimer's disease, Parkinson's disease, or multiple sclerosis,
• unable or unwilling to comply with study protocol.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes Universty

Kayseri, Talas, 38039, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pain; Personal Satisfaction; Arteriovenous Fistula

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: During the data collection process, the sample of the study consisted of 60 individuals who met the inclusion criteria and were selected according to a computer-generated randomization list.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Dr

Model Details: 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

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: April 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)