Clinical trial · Interventional
Effect of Lidocaine Gel and Cold Lidocaine Gel on Pain in Patients Who Had Prostate Biopsy With Transrectal Ultrasound
Effect of Lidocaine Gel and Cold Lidocaine Gel Applied to the Rectal Area on Pain in Patients Who Had Prostate Biopsy With Transrectal Ultrasound: Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer XXX | — | UNRESOLVED | — |
| TRANSRECTAL ULTRASOUND-GUIDED PROSTATE BIOPSY | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| COLD LIDOCAINE GEL | Other | — | UNRESOLVED |
| LIDOCAINE GEL | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- CONTROL
- description
- 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.
- type
- EXPERIMENTAL
- label
- LIDOCAINE GEL (LG)
- description
- 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).
- interventionNames
- Other: LIDOCAINE GEL
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Being able to communicate effectively, * Being over 40 years old, * Being literate, * Volunteering to participate in the research. Exclusion Criteria: * 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.
References
Publications (0)
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