Effect of Lidocaine Gel and Cold Lidocaine Gel on Pain in Patients Who Had Prostate Biopsy With Transrectal Ultrasound

NCT06429046 | Completed

• 1 other identifier: CukurovaUSFırat2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer is one of the most common types of malignancy in men. Transrectal ultrasound-guided prostate biopsy (TRUSG-PBx) is considered the current gold standard method in the diagnosis of prostate cancer. Some patients experience serious discomfort during the procedure because the ultrasound probe is placed in the rectal area. Although no anesthetic or analgesic is used in some centers during the prostate biopsy procedure, in some centers lidocaine gel, cream or spray is applied before entering the rectal area, and lidocaine ampoule is injected during the procedure. However, most patients experience pain and discomfort due to the way the procedure is performed. Today, in addition to pharmacological methods, non-pharmacological methods are also used to control pain. Cold application has an important place among non-pharmacological methods. In this randomized controlled intervention study, the effect of cold lidocaine gel application on pain level in patients undergoing transrectal ultrasound-guided prostate biopsy (TRUSG-PBx) will be evaluated. In this study, it is thought that application of cold lidocaine gel will reduce the pain level of patients. The research will be conducted at the Urology Polyclinic of Çukurova University Faculty of Medicine Balcalı Practice and Research Hospital. The sample of the research; Ç.Ü.T.F. Volunteer patients who have undergone prostate biopsy at the Urology Polyclinic of Balcalı Practice and Research Hospital and meet the research criteria will be recruited. Patients consisting of 3 groups: control, experiment 1 (Lidocaine Gel) and experiment 2 (Cold Lidocaine Gel) will be determined by randomization. A power analysis was carried out by obtaining statistical support for the sample size. As a result of the sample calculation calculated with power with a confidence interval of 95%, beta value of 95% and alpha value of 0.05, a total of 114 patients will be included, 38 each in the control group, Lidocaine gel and Cold Lidocaine Gel groups. . Data will be collected with the "Personal Information Form" and "Pain Assessment Form". The data will be analyzed in the SPSS (Statistical Package for the Social Sciences) package program. In this context, in our study, the effect of lidocaine gel and cold lidocaine gel applied to the rectal area on the pain level in patients who underwent transrectal ultrasound-guided prostate biopsy will be evaluated and the effect of cold application on pain control will be compared. This result will make great contributions to patient benefit in terms of pain management.

Conditions

Prostate Cancer XXX; TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY

Keywords

Cold application

Outcome Measures

Primary Outcomes (1)

• Pain Evaluation Form

  The scale used in the first part of this form, which aims to evaluate pain severity, is the Numerical Pain Scale (NPS). On this scale, it starts with no pain (0) and reaches the level of unbearable pain (10). It was applied according to the determined measurement times of the patients \[At the beginning of the biopsy/while the ultrasound probe was being inserted (NPS) -1), During the biopsy/5 minutes after the ultrasound probe was placed (NPS-2), At the end of the biopsy/when the ultrasound probe was being removed (NPS-3)\].

  The first 24 hours: NPS 1, 2, 3.

Secondary Outcomes (1)

• Personal Information Form

  Personal Information Form was applied before the transaction

Study Arms (3)

CONTROL

NO INTERVENTION

For patients in the control group, "Personal Information Form" will be applied before the procedure and pain will be evaluated with "Numeric Pain Scale". NPS will be applied at the beginning of the procedure when the ultrasound probe is placed (NPS-1), 5 minutes after the procedure (NPS-2) and at the end of the procedure when the probe is removed (NPS-3). However, no treatment will be performed on control group patients.

LIDOCAINE GEL (LG)

EXPERIMENTAL

Data will be collected in two stages. To LG group patients, 20 ml lidocaine gel will be applied intrarectally (double application: 5cc to the perianal region, covering the anal sphincter, the remaining 15cc into the rectum) 5 minutes before the transrectal ultrasound probe is placed in the rectum. Patients in the LG group will be administered a "Personal Information Form" before the procedure, and their pain will be evaluated with the "Numeric Pain Scale". NPS will be applied at the beginning of the procedure when the ultrasound probe is placed (NPS-1), 5 minutes after the procedure (NPS-2) and at the end of the procedure when the probe is removed (NPS-3).

Other: LIDOCAINE GEL

COLD LIDOCAINE GEL (CLG)

EXPERIMENTAL

Similarly, patients in the CLG group will be administered "Personal Information Form" before the procedure and pain will be evaluated with "Numeric Pain Scale". In CLG group patients, 20 ml of cold lidocaine gel kept in the refrigerator at +4 0C will be applied intrarectally (double application: 5cc to the perianal region, including the anal sphincter, the remaining 15cc into the rectum) 5 minutes before the transrectal ultrasound probe is placed into the rectum.NPS will be applied at the beginning of the procedure when the ultrasound probe is placed (NPS-1), 5 minutes after the procedure (NPS-2) and at the end of the procedure when the probe is removed (NPS-3).

Other: COLD LIDOCAINE GEL

Interventions

LIDOCAINE GEL OTHER

To LG group patients, 20 ml lidocaine gel will be applied intrarectally (double application: 5cc to the perianal region, covering the anal sphincter, the remaining 15cc into the rectum) 5 minutes before the transrectal ultrasound probe is placed in the rectum.

LIDOCAINE GEL (LG)

COLD LIDOCAINE GEL OTHER

In CLG group patients, 20 ml of cold lidocaine gel kept in the refrigerator at +4 0C will be applied intrarectally (double application: 5cc to the perianal region, including the anal sphincter, the remaining 15cc into the rectum) 5 minutes before the transrectal ultrasound probe is placed into the rectum.

COLD LIDOCAINE GEL (CLG)

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: PROSTATE
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being able to communicate effectively,
• Being over 40 years old,
• Being literate,
• Volunteering to participate in the research.

You may not qualify if:

• Having a previous history of chronic pain,
• Having alcohol and drug addiction,
• Having bleeding diathesis and active urinary tract infection,
• Having a cognitive disorder, neurological or psychiatric disease,
• Having a disease in the anal and rectal area (wound, fistula, fissure, hemorrhoids, etc.).
• Not agreeing to participate in the research.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Sariçam, 01330, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study was planned to compare the effects of lidocaine gel and cold lidocaine gel application to the rectal area on the pain level in patients who underwent TRUSG-guided prostate biopsy.

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 24, 2024
• Study Start: January 2, 2020
• Primary Completion: July 29, 2022
• Study Completion: September 12, 2023
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

TU (1)