Pudendal Neuralgia Pudendal Nerve Entrapment Chronic Pelvic PainNCT07828574
Pudendal Nerve Block With Articaine and Triamcinolone for Pudendal Neuralgia
A study testing Articaine and triamcinolone in people with Pudendal Neuralgia Pudendal Nerve Entrapment Chronic Pelvic Pain, run by Irkutsk State Medical University at 1 site in Russia.
Trial summary
This study is testing whether an injection of local anesthetic (articaine) combined with a steroid (triamcinolone), placed near the pudendal nerve under ultrasound guidance, can reduce pain in people with pudendal neuralgia - a chronic pain condition affecting the perineal area - when other treatments (such as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pudendal Neuralgia Pudendal Nerve Entrapment Chronic Pelvic Pain
- What is being tested?
- Articaine and triamcinolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jan 2025to 10 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Nantes criteria for pudendal neuralgia (all 4 mandatory criteria)
- Pain intensity on the Numeric Rating Scale (NRS) greater than 4 out of 10 during the previous 7 days
- Pain duration exceeding 3 months
- Failure of prior conservative therapy (pregabalin ≥150 mg/day, or gabapentin ≥900 mg/day, or physical therapy) for more than 8 weeks
- Age 18 years or older
Who cannot join
- Pudendal nerve compression by a space-occupying lesion (tumor, cyst, endometriosis) on pelvic MRI
- Coagulopathy (INR >1.4, platelets <50×10^9/L)
- Use of anticoagulants or antiplatelet agents that cannot be discontinued 5-7 days before the block (per cardiology consultation)
- Active infection at the intended injection site, or systemic infection/sepsis
- Allergy to amide-type local anesthetics or corticosteroids
- Pregnancy or lactation
- Psychiatric conditions precluding understanding of the procedure or completion of questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Pudendal Nerve Block With Articaine and Triamcinolone in Patients With Pudendal Neuropathy: A Prospective Randomized Placebo-Controlled Trial With Blinded Outcome Assessment
This study is testing whether an injection of local anesthetic (articaine) combined with a steroid (triamcinolone), placed near the pudendal nerve under ultrasound guidance, can reduce pain in people with pudendal neuralgia - a chronic pain condition affecting the perineal area - when other treatments (such as medications and physical therapy) have not worked well enough.
Participants are randomly assigned to receive either the active injection (articaine and triamcinolone) or a placebo injection (saline solution), without knowing which one they receive. Neither the participant, the person performing the injection, nor the person assessing the results afterward knows which group the participant is in.
The main question the study is trying to answer is whether more people report at least 50% less pain four weeks after the injection with the active treatment compared with placebo. The study also looks at quality of life, sleep, physical function, use of pain medication, and side effects over 24 weeks after the injection.
Read the detailed description
This is a single-center, prospective, randomized, placebo-controlled, parallel-group trial conducted at Kharlampiev Clinic (Irkutsk, Russia), a clinical base of Irkutsk State Medical University. Patients meeting the clinical Nantes criteria for pudendal neuralgia, with pain refractory to conservative therapy, are randomized 1:1 to receive a single ultrasound-guided transperineal pudendal nerve block with either articaine 5 mL (20 mg/mL with epinephrine 1:200,000) plus triamcinolone acetonide 40 mg, or an equal volume of 0.9% saline (placebo), both brought to a total volume of 10 mL with saline.
Randomization is performed using a computer-generated sequence with a fixed block size, by an independent staff member not involved in patient care or outcome assessment. Study medication is prepared by a designated unblinded staff member; the treating physician, outcome assessor, and participant remain blinded to group assignment throughout the study.
The primary outcome is the proportion of participants achieving a reduction of more than 50% in pain intensity on a 0-10 Numeric Rating Scale (NRS) at 4 weeks after the injection. Secondary outcomes include NRS pain scores at 1, 2, 8, 12, and 24 weeks; quality of life (EQ-5D-5L); sleep quality (Pittsburgh Sleep Quality Index, PSQI); pudendal neuralgia-specific functional status (PNEQ); rescue analgesic use; and treatment-related adverse events over 24 weeks of follow-up.
- Being tested
- Articaine and triamcinolone, Placebo (0.9% sodium chloride)
- Keywords
- pudendal nerve block articaine triamcinolone ultrasound-guided nerve block randomized controlled trial placebo-controlled chronic perineal pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articaine and triamcinoloneDrug
Perineural injection of articaine hydrochloride with epinephrine (20 mg/mL + 0.005 mg/mL, 5 mL) combined with triamcinolone acetonide (40 mg in 1 mL), diluted with 0.9% saline to a total volume of 10 mL, administered as a single ultrasound-guided transperineal pudendal nerve block.
Placebo (0.9% sodium chloride)Drug
Single ultrasound-guided transperineal injection of 10 mL of 0.9% sodium chloride solution (saline), using the same needle, approach, and injection technique as the active intervention, without active pharmacological agent.
| Study group | Role | What they receive |
|---|---|---|
| Active block | Experimental | Single ultrasound-guided transperineal pudendal nerve block with articaine (5 mL, 20 mg/mL with epinephrine 1:200,000) and triamcinolone acetonide (40 mg/1 mL), diluted with 0.9% saline to a total volume of 10 mL. Receives: Drug: Articaine and triamcinolone |
| Placebo block | Placebo comparator | Single ultrasound-guided transperineal injection of 10 mL of 0.9% saline, using the identical needle, approach, and injection technique as the active arm. Receives: Drug: Placebo (0.9% sodium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With ≥50% Reduction in Pain Intensity at 4 Weeks
Proportion of participants achieving more than 50% reduction in pain intensity on the 0-10 Numeric Rating Scale (NRS) compared with baseline, assessed 4 weeks after the pudendal nerve block.
Measured: 4 weeks
Secondary outcomes (6)
Change in Pain Intensity (NRS) Over Time
Absolute change in pain intensity from baseline on the 0-10 Numeric Rating Scale.
Measured: Baseline, 1, 2, 4, 8, 12, and 24 weeks
Change in Quality of Life (EQ-5D-5L)
Change from baseline in health-related quality of life, measured by the EQ-5D-5L index score.
Measured: Baseline, 12 and 24 weeks
Change in Sleep Quality (PSQI)
Change from baseline in sleep quality, measured by the Pittsburgh Sleep Quality Index (PSQI) total score.
Measured: Baseline and 12 weeks
Change in Pudendal Neuralgia-Specific Functional Status (PNEQ)
Change from baseline in pudendal-neuralgia-specific functional status, measured by the Pudendal Neuralgia Functional Questionnaire (PNEQ) total score.
Time Frame: Baseline and 12 weeks
Measured: Baseline and 12 weeks
Rescue Analgesic Use
Number of days per 4-week interval on which participants used rescue analgesics (nimesulide or ibuprofen), recorded in a patient diary.
Measured: Every 4 weeks, up to 24 weeks
Incidence of Treatment-Related Adverse Events
Proportion of participants with procedure- or treatment-related adverse events, including injection-site hematoma, infection, transient pain exacerbation, and systemic anesthetic effects.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start15 Jan 2025
- Primary completion18 Jun 2026
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pudendal Neuralgia Pudendal Nerve Entrapment Chronic Pelvic PainStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irkutsk State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan A. Stepanov, Irkutsk State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828574
- Sponsor's protocol ID
- 4/20122024
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pudendal Nerve Block With Articaine and Triamcinolone in Patients With Pudendal Neuropathy: A Prospective Randomized Placebo-Controlled Trial With Blinded Outcome Assessment
- ClinicalTrials.gov ID
- NCT07828574
- Acronym / sponsor ID
- 4/20122024
- Keywords
- pudendal nerve block articaine triamcinolone ultrasound-guided nerve block randomized controlled trial placebo-controlled chronic perineal pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Irkutsk State Medical UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 18 Jun 2026 (actual)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 18 Sep 2026 (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 is testing whether an injection of local anesthetic (articaine) combined with a steroid (triamcinolone), placed near the pudendal nerve under ultrasound guidance, can reduce pain in people with pudendal neuralgia - a chronic pain condition affecting the perineal area - when other treatments (such as medications and physical therapy) have not worked well enough.
Participants are randomly assigned to receive either the active injection (articaine and triamcinolone) or a placebo injection (saline solution), without knowing which one they receive. Neither the participant, the person performing the injection, nor the person assessing the results afterward knows which group the participant is in.
The main question the study is trying to answer is whether more people report at least 50% less pain four weeks after the injection with the active treatment compared with placebo. The study also looks at quality of life, sleep, physical function, use of pain medication, and side effects over 24 weeks after the injection.
Detailed description
This is a single-center, prospective, randomized, placebo-controlled, parallel-group trial conducted at Kharlampiev Clinic (Irkutsk, Russia), a clinical base of Irkutsk State Medical University. Patients meeting the clinical Nantes criteria for pudendal neuralgia, with pain refractory to conservative therapy, are randomized 1:1 to receive a single ultrasound-guided transperineal pudendal nerve block with either articaine 5 mL (20 mg/mL with epinephrine 1:200,000) plus triamcinolone acetonide 40 mg, or an equal volume of 0.9% saline (placebo), both brought to a total volume of 10 mL with saline.
Randomization is performed using a computer-generated sequence with a fixed block size, by an independent staff member not involved in patient care or outcome assessment. Study medication is prepared by a designated unblinded staff member; the treating physician, outcome assessor, and participant remain blinded to group assignment throughout the study.
The primary outcome is the proportion of participants achieving a reduction of more than 50% in pain intensity on a 0-10 Numeric Rating Scale (NRS) at 4 weeks after the injection. Secondary outcomes include NRS pain scores at 1, 2, 8, 12, and 24 weeks; quality of life (EQ-5D-5L); sleep quality (Pittsburgh Sleep Quality Index, PSQI); pudendal neuralgia-specific functional status (PNEQ); rescue analgesic use; and treatment-related adverse events over 24 weeks of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active block | Experimental | Drug: Articaine and triamcinoloneSingle ultrasound-guided transperineal pudendal nerve block with articaine (5 mL, 20 mg/mL with epinephrine 1:200,000) and triamcinolone acetonide (40 mg/1 mL), diluted with 0.9% saline to a total volume of 10 mL. |
| Placebo block | Placebo comparator | Drug: Placebo (0.9% sodium chloride)Single ultrasound-guided transperineal injection of 10 mL of 0.9% saline, using the identical needle, approach, and injection technique as the active arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical Nantes criteria for pudendal neuralgia (all 4 mandatory criteria)
- Pain intensity on the Numeric Rating Scale (NRS) greater than 4 out of 10 during the previous 7 days
- Pain duration exceeding 3 months
- Failure of prior conservative therapy (pregabalin ≥150 mg/day, or gabapentin ≥900 mg/day, or physical therapy) for more than 8 weeks
- Age 18 years or older
Key exclusion criteria (7 listed)
- Pudendal nerve compression by a space-occupying lesion (tumor, cyst, endometriosis) on pelvic MRI
- Coagulopathy (INR >1.4, platelets <50×10^9/L)
- Use of anticoagulants or antiplatelet agents that cannot be discontinued 5-7 days before the block (per cardiology consultation)
- Active infection at the intended injection site, or systemic infection/sepsis
- Allergy to amide-type local anesthetics or corticosteroids
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 |
|---|---|---|
| Articaine and triamcinolonePerineural injection of articaine hydrochloride with epinephrine (20 mg/mL + 0.005 mg/mL, 5 mL) combined with triamcinolone acetonide (40 mg in 1 mL), diluted with 0.9% saline to a total volume of 10 mL, administered as a single ultrasound-guided transperineal pudendal nerve block. | Drug | Active block |
| Placebo (0.9% sodium chloride)Single ultrasound-guided transperineal injection of 10 mL of 0.9% sodium chloride solution (saline), using the same needle, approach, and injection technique as the active intervention, without active pharmacological agent. | Drug | Placebo block |
Primary outcome
Proportion of Participants With ≥50% Reduction in Pain Intensity at 4 Weeks
Time frame: 4 weeks
Proportion of participants achieving more than 50% reduction in pain intensity on the 0-10 Numeric Rating Scale (NRS) compared with baseline, assessed 4 weeks after the pudendal nerve block.
6 secondary outcomes
Change in Pain Intensity (NRS) Over Time
Time frame: Baseline, 1, 2, 4, 8, 12, and 24 weeks
Change in Quality of Life (EQ-5D-5L)
Time frame: Baseline, 12 and 24 weeks
Change in Sleep Quality (PSQI)
Time frame: Baseline and 12 weeks
Change in Pudendal Neuralgia-Specific Functional Status (PNEQ)
Time frame: Baseline and 12 weeks
Rescue Analgesic Use
Time frame: Every 4 weeks, up to 24 weeks
Incidence of Treatment-Related Adverse Events
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Articaine and triamcinolone in people with Pudendal Neuralgia Pudendal Nerve Entrapment Chronic Pelvic Pain, run by Irkutsk State Medical University at 1 site in Russia.
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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. 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 Russia. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of Participants With ≥50% Reduction in Pain Intensity at 4 Weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2026.