Pain, AcuteNCT06737939
Periprostatic Nerve Block vs. Intravenous Ibuprofen for Pain Management During Transrectal Prostate Biopsy
A study testing intravenous ibuprofen and periprostatic nerve block in people with Pain, Acute, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 82 years, men only
- Conditions the study is for
- Pain, Acute
- What is being tested?
- intravenous ibuprofen and periprostatic nerve block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 82 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male gender. Scheduled for a prostate biopsy. Prostate-specific antigen (PSA) levels > 4 ng/mL.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziantep University Hospital
Gaziantep, 27310
About this study
Official title: Periprostatic Nerve Block vs. Intravenous Ibuprofen for Pain Management During Transrectal Prostate Biopsy: A Prospective Comparative Study
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.
Read the detailed description
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
- Pain, Acute
- Being tested
- intravenous ibuprofen, periprostatic nerve block
- Keywords
- Prostate biopsy, ıv ibuprofen, periprostatic nerve block, visual analog scale
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: intravenous ibuprofen |
| Periprostatic nerve block | Experimental | Periprostatic Nerve Block (PPNB) using 2% lidocaine was administered for pain relief during the prostate biopsy procedure. Receives: Other: periprostatic nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the biopsy, During probe insertion and prostate needle insertion,2 hours and 1 day after the procedure
Secondary outcomes (1)
Complications
Complications (such as bleeding, nausea vomiting etc)
Measured: immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Jun 2023
- Primary completion1 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzem SEN, University of Gaziantep
- Investigators
- Elzem Sen, Assoc Prof, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737939
- Sponsor's protocol ID
- 2023/51
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41537216
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periprostatic Nerve Block vs. Intravenous Ibuprofen for Pain Management During Transrectal Prostate Biopsy: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT06737939
- Acronym / sponsor ID
- 2023/51
- Conditions
- Pain, Acute
- Keywords
- Prostate biopsy, ıv ibuprofen, periprostatic nerve block, visual analog scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen group | Experimental | Other: intravenous ibuprofenEach 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. |
| Periprostatic nerve block | Experimental | Other: periprostatic nerve blockPeriprostatic Nerve Block (PPNB) using 2% lidocaine was administered for pain relief during the prostate biopsy procedure. |
Who may qualify
- Ages
- 45 to 82 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male gender. Scheduled for a prostate biopsy. Prostate-specific antigen (PSA) levels > 4 ng/mL.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous ibuprofenA systemic analgesic (NSAID) administered intravenously for pain management during prostate biopsy, without the need for additional invasive interventions. | Other | Ibuprofen group |
| periprostatic nerve blockA 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. | Other | Periprostatic nerve block |
Primary outcome
Visual analog scale (VAS)
Time frame: Before the biopsy, During probe insertion and prostate needle insertion,2 hours and 1 day after the procedure
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.
1 secondary outcome
Complications
Time frame: immediately after the intervention/procedure/surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Derived from this study: PubMed 41537216Baturu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elzem Sen, Assoc Prof principal investigator
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous ibuprofen and periprostatic nerve block in people with Pain, Acute, run by University of Gaziantep at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: Before the biopsy, During probe insertion and prostate needle insertion,2 hours and 1 day after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06737939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.