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临床试验/NCT07242157
NCT07242157已完成3 期

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

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Pain level (Visual Anolog Scale)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

盲法说明

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.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Group II : Benzocain Sprey

Experimental

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

干预措施: Benzocaine spray (Drug)

Group III: Placebo

Placebo Comparator

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

干预措施: Placebo group (control arm) (Drug)

结局指标

主要结局

Pain level (Visual Anolog Scale)

时间窗: 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.

次要结局

  • Injection Satisfaction Scale(Evaluation was made immediately after application)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevil Şahin

Assoc Prof Dr

TC Erciyes University

研究点 (1)

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