Periprostatic Nerve Block vs. Intravenous Ibuprofen for Pain Management During Transrectal Prostate Biopsy

University of Gaziantep128 enrolled

Overview

This study aimed to compare the efficacy of intravenous ibuprofen with peri-prostatic nerve block in pain control during prostate biopsy and to investigate factors influencing pain scores.

This study aimed to compare the efficacy of intravenous (IV) ibuprofen with periprostatic nerve block (PPNB) in controlling pain during prostate biopsy, a common procedure used to diagnose prostate cancer. The study also aimed to investigate factors influencing pain perception during the procedure, such as prostate-specific antigen (PSA) levels, prostate volume, and comorbidities.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

128

Conditions

Pain, Acute

Interventions

intravenous ibuprofenOTHER

A systemic analgesic (NSAID) administered intravenously for pain management during prostate biopsy, without the need for additional invasive interventions.

periprostatic nerve blockOTHER

A local anesthetic injection targeting the periprostatic nerves to provide direct pain relief during the biopsy procedure, considered the gold standard for pain management in prostate biopsies.

Eligibility

Sex: MALEMin age: 45 YearsMax age: 82 Years

Medical Language ↔ Plain English

Inclusion Criteria: Male gender. Scheduled for a prostate biopsy. Prostate-specific antigen (PSA) levels \> 4 ng/mL. Exclusion Criteria: Renal failure. Liver failure. Neurological disorders (e.g., dementia, Alzheimer's disease, epilepsy, paraplegia). Rectal disorders. Previous negative prostate biopsy. Chronic anticoagulant therapy or bleeding diathesis. Severe comorbidities. Psychiatric conditions interfering with consent or compliance.

Locations (1)

Gaziantep University Hospital

Gaziantep, Turkey (Türkiye)

Outcomes

Primary Outcomes

Visual analog scale (VAS)

Pain Assessment using Visual Analog Scale (VAS),The Visual Analog Scale (VAS) is a tool used to measure subjective characteristics or attitudes that cannot be directly measured. It typically consists of a 10 cm (100 mm) horizontal or vertical line, anchored by two endpoints representing extremes of the sensation being measured. Range: Scores range from 0 (minimum) to 10 (maximum). Interpretation: Higher scores indicate a worse outcome (e.g., greater pain intensity or distress). Description: Participants mark a point along the line that corresponds to the intensity of their experience. The score is determined by measuring the distance (in centimeters or millimeters) from the lower end of the scale to the participant's mark.

Time frame: Before the biopsy, During probe insertion and prostate needle insertion,2 hours and 1 day after the procedure

Secondary Outcomes

Complications

Complications (such as bleeding, nausea vomiting etc)

Time frame: immediately after the intervention/procedure/surgery

Data from ClinicalTrials.gov

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