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

NCT06737939 | Completed

• 1 other identifier: 2023/51
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Acute

Keywords

Prostate biopsy; ıv ibuprofen; periprostatic nerve block; visual analog scale

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Complications

  immediately after the intervention/procedure/surgery

Study Arms (2)

Ibuprofen group

EXPERIMENTAL

Each patient in Group 1 received 400 mg of IV ibuprofen diluted in 100 mL of solution. The infusion was administered over a 30-minute period to ensure proper absorption and minimize adverse effects.

Other: intravenous ibuprofen

Periprostatic nerve block

EXPERIMENTAL

Periprostatic Nerve Block (PPNB) using 2% lidocaine was administered for pain relief during the prostate biopsy procedure.

Other: periprostatic nerve block

Interventions

intravenous ibuprofen OTHER

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

Ibuprofen group

periprostatic nerve block OTHER

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.

Periprostatic nerve block

Eligibility Criteria

• Age: 45 Years - 82 Years
• Gender Eligibility Details: Since the study involves a prostate biopsy, which is a procedure specifically related to the prostate gland, only male participants were included. The prostate is an organ found only in men, making this a male-only study population.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male gender. Scheduled for a prostate biopsy. Prostate-specific antigen (PSA) levels \> 4 ng/mL.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep University Hospital

Gaziantep, 27310, Turkey (Türkiye)

Location

Related Publications (1)

• Baturu M, Sen E. Periprostatic Nerve Block vs. Intravenous Ibuprofen for Pain Management During Transrectal Prostate Biopsy Procedures: A Prospective Comparative Study. Ann Ital Chir. 2025 Sep 16;97(1):119-125. doi: 10.62713/aic.3938.

  PMID: 41537216 DERIVED

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elzem Sen, Assoc Prof

  University of Gaziantep

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.Dr

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 17, 2024
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

TU (1)