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

NCT ID: NCT06737939

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain, Acute

Keywords

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Prostate biopsy ıv ibuprofen periprostatic nerve block visual analog scale

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Ibuprofen group

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.

Group Type EXPERIMENTAL

intravenous ibuprofen

Intervention Type OTHER

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

Periprostatic nerve block

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

Group Type EXPERIMENTAL

periprostatic nerve block

Intervention Type 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.

Interventions

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intravenous ibuprofen

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

Intervention Type OTHER

periprostatic nerve block

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

82 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Gaziantep

OTHER

Sponsor Role lead

Responsible Party

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Elzem SEN

Assoc. Prof.Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elzem Sen, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

University of Gaziantep

Locations

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Gaziantep University Hospital

Gaziantep, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023/51

Identifier Type: -

Identifier Source: org_study_id