Bupivacaine Injection for Pudendal Neuralgia

Overseen By Sean Francis, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Louisville

Disqualifiers: Pregnancy, Recent pelvic surgery, Neurologic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods of administering pain relief injections for pudendal neuralgia, a chronic pain condition affecting the pelvic area. Researchers aim to determine whether the transvaginal approach (through the vaginal wall) or the fluoroscopy-guided approach (using X-ray guidance) provides better pain relief. Women who have experienced pelvic pain related to the pudendal nerve for at least three months and seek pain relief through nerve block injections may be suitable participants. The main treatment involves injections of bupivacaine, a medication that numbs the area to relieve pain. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Bupivacaine?

Research has shown that bupivacaine, used in pudendal nerve blocks, is generally safe for pain relief. Past studies have demonstrated that these nerve blocks effectively reduce pain and maintain a good safety record. They manage pain during certain medical procedures and reduce the need for other painkillers.

For the transvaginal method, the main concern involves the risk of accidentally puncturing nearby blood vessels, which can lead to serious issues. However, careful administration keeps these risks low. The fluoroscopy-guided method, which uses imaging to guide the injection, is considered safe and effective. This approach allows for more precise treatment, enhancing safety.

Both methods, when performed by experienced healthcare providers, have been well-tolerated by patients in past studies. No major safety concerns have been reported, indicating that bupivacaine is a reliable option for managing pudendal neuralgia pain. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for pudendal neuralgia because they offer innovative approaches to pain management. Unlike typical treatments that may involve medication or surgery, these methods utilize targeted bupivacaine injections directly into the pudendal nerves. The transvaginal approach delivers consistent pain relief over three sessions, while the fluoroscopy-guided technique offers precision with just a single injection. These methods could potentially provide more effective and quicker relief with fewer side effects compared to traditional options.

What evidence suggests that this trial's treatments could be effective for pudendal neuralgia?

In this trial, participants will receive bupivacaine injections to relieve pain from pudendal neuralgia, a condition causing ongoing pelvic pain. Bupivacaine numbs the pudendal nerve, reducing pain quickly and often lasting several hours. Participants in one arm of the trial will receive the transvaginal pudendal nerve block method, which has successfully managed this type of pain. Another arm will use the fluoroscopy-guided method, which research suggests may also be effective, especially for patients whose pain hasn't improved with other treatments. Overall, both methods using bupivacaine show promise in easing the discomfort of pudendal neuralgia. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing chronic pelvic or urogenital pain, diagnosed with pudendal neuralgia. It's aimed at those who have not found relief from other treatments and are suitable candidates for nerve block procedures.

Inclusion Criteria

I want a pudendal nerve block for pain relief.

I have been diagnosed with pudendal neuralgia or chronic pelvic pain for 3+ months.

My pain or discomfort level is at least 4 out of 10.

Exclusion Criteria

I don't have skin or vaginal infections, allergies to bupivacaine, or blood clotting issues.

Pregnant or intending to become pregnant during the study

I have not had pelvic surgery in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either transvaginal or fluoroscopy-guided pudendal nerve block for pain relief

6 weeks

3 visits (in-person) for transvaginal group, 1 visit (in-person) for fluoroscopy group

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Weekly assessments (virtual or in-person)

Crossover Option

Participants have the option to crossover to the alternative treatment arm after the initial 6-week follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine

Trial Overview The study compares two methods of administering a pudendal nerve block to relieve pelvic pain: one using transvaginal finger guidance and the other using fluoroscopy (a type of X-ray) for guidance through the gluteal area.

How Is the Trial Designed?

Group I: Transvaginal pudendal nerve block Experimental Treatment 1 Intervention

Participants in this arm will receive 10 mL bupivacaine injected into bilateral pudendal nerves via transvaginal approach. This is performed by palpating 1 cm superior and medial to the ischial spine. Participants will receive an injection each 2 weeks, for a total of 3 injections over 6 weeks.

Group II: Fluoroscopy guided pudendal nerve block Experimental Treatment 1 Intervention

Participants in this arm will receive 5 mL bupivacaine injected into bilateral pudendal nerves via fluoroscopic guided trans gluteal approach. They will receive one injection over the 6-week duration.

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in European Union as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Published Research Related to This Trial

Pudendal nerve block using a transsacral approach at S2-S4 with lidocaine and methylprednisolone provided significant pain relief for two patients suffering from severe chronic vaginal pain, reducing their pain scores from 9 and 10 to 1 and 0 after one month.

This method is suggested as an effective alternative treatment for pudendal neuralgia when traditional pudendal nerve block techniques are not suitable, demonstrating long-term pain relief at a 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transsacral S2-S4 nerve block for vaginal pain due to pudendal neuralgia. Cok, OY., Eker, HE., Cok, T., et al.[2011]

Laparoscopic pudendal release combined with neurostimulation has been proposed as a new treatment for pudendal neuralgia, which is a painful condition that can be very disabling.

This experimental technique has shown promising results in one patient, suggesting it may be an effective option for those who have not responded to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Right laparoscopic pudendal release + neurostimulator prosthesis (LION procedure) in pudendal neuralgia. Moncada, E., de San Ildefonso, A., Flores, E., et al.[2022]

In a study of 51 patients with pudendal neuralgia (PN), 73% showed improvement with a mixed analgesic treatment, highlighting the efficacy of first-line neuropathic pain management.

Pain intensity linked to dorsal clitoris nerve damage and sensory deficits in the S2-S4 dermatome were identified as poor prognostic factors, indicating that these conditions may lead to a lower likelihood of responding to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic perineal pain: analyses of prognostic factors in pudendal neuralgia. Pereira, A., Pérez-Medina, T., Rodríguez-Tapia, A., et al.[2014]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

In a study of 10 patients with radiculopathy, a low-volume epidural injection of Marcaine significantly improved physical examination parameters, specifically seated slump testing and straight-leg raising, indicating effective pain relief.

The H-reflex latency showed a significant change on the affected side post-injection, suggesting potential alterations in nerve function, although the clinical relevance of this finding remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

H-reflex latency and nerve root tension sign correlation in fluoroscopically guided, contrast-confirmed, translaminar lumbar epidural steroid-bupivacaine injections. Stretanski, MF.[2019]

In a study of 49 patients with suspected pudendal neuralgia, 70% of those with typical symptoms experienced significant relief from pain after CT-guided dual site infiltration, compared to only 27% with atypical symptoms.

Most patients (84%) who responded positively felt relief after just the first injection, with the average duration of relief lasting about 3 months, highlighting the efficacy of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[CT guided dual site infiltration in pudendal neuralgia]. Puget, J., Kastler, B., Aubry, S., et al.[2019]

CT-guided percutaneous infiltration of the pudendal nerve with a local anesthetic and long-acting corticosteroid is a safe and effective treatment for Alcock's neuralgia, a painful condition caused by pudendal nerve compression.

The procedure provides initial pain relief from the local anesthetic, followed by longer-lasting relief as the corticosteroid takes effect over 3-5 days, with no complications reported when steroids are administered within therapeutic doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CT-guided percutaneous infiltration for the treatment of Alcock's neuralgia. Filippiadis, DK., Velonakis, G., Mazioti, A., et al.[2022]

In a study involving 30 patients, two forms of 0.5% bupivacaine hydrochloride (Anecaine and Marcaine) were compared for epidural anesthesia, revealing differences in how quickly and effectively they provided pain relief.

Anecaine showed a shorter onset of analgesia at the catheter site but a delayed effect in peripheral areas compared to Marcaine, indicating that even the same active ingredient can behave differently based on the manufacturer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. Kozlov, SP., Vashchinskaia, TV., Svetlov, VA.[2013]

Bupivacaine with a vasoconstrictor has a shorter onset time for local anesthesia compared to bupivacaine without a vasoconstrictor, but the duration of anesthesia is longer without the vasoconstrictor.

Using bupivacaine without a vasoconstrictor resulted in lower postoperative pain levels and better blood circulation, which is beneficial for the osseointegration of dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. Duka, M., Lazić, Z., Stamatović, N., et al.[2019]

In a study involving 20 healthy adult dogs, the volume of 0.25% bupivacaine (Bu) injected epidurally significantly influenced the extent of sensory and motor blocks, with 0.6 mL kg(-1) providing an effective sensory block across 20.2 dermatomes.

Motor block was found to be longer-lasting and more intense than sensory block, and complete spinal cord dyeing with methylene blue was achieved at 0.6 mL kg(-1), indicating that this volume is crucial for effective epidural anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine 0.25% and methylene blue spread with epidural anesthesia in dog. Freire, CD., Torres, ML., Fantoni, DT., et al.[2017]

Chronic pudendal neuromodulation (CPN) significantly improved pain symptoms in patients with pudendal neuralgia, with 63% of participants reporting substantial pain relief after treatment.

In a survey of patients, 80% found CPN more effective than nerve blocks for pain management, indicating a higher satisfaction rate with CPN compared to previous treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study Exploring Chronic Pudendal Neuromodulation as a Treatment Option for Pain Associated with Pudendal Neuralgia. Peters, KM., Killinger, KA., Jaeger, C., et al.[2022]

High-voltage, long-duration pulsed radiofrequency (PRF) treatment applied to the pudendal nerve significantly improved pain levels and quality of life in 70 patients with pudendal neuralgia, with an effective rate of 88.6% at 12 weeks post-treatment.

Patients reported notable reductions in pain (measured by the visual analog scale), improved health-related quality of life (SF-36), and decreased symptoms of depression (PHQ-9) after the treatment, indicating both safety and clinical efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Efficacy of High-Voltage Long-Duration Pulsed Radiofrequency Treatment in Pudendal Neuralgia: A Retrospective Study. Wang, CL., Song, T.[2022]

Pudendal nerve perineural injections (PNPIs) using bupivacaine significantly reduce pain in patients with pudendal neuropathy, with 80.4% of patients reporting less pain after the procedure.

The effectiveness of pain relief from PNPIs is correlated with the number of nerve branches anesthetized, indicating that a greater number of successfully treated branches leads to better pain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the Quality of Pudendal Nerve Perineural Injections. Antolak, S., Antolak, C., Lendway, L.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11084891/

Fluoroscopy-Guided Transgluteal Pudendal Nerve Block for ... Fluoroscopy-guided transgluteal pudendal nerve block appears to be effective in patients who have pudendal neuralgia that is resistant to conservative therapy.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06644261

Transvaginal Versus Fluoroscopy-guided Trans Gluteal ... The purpose of this prospective, non-inferiority, randomized controlled trial is to compare the efficacy of pain relief from bilateral transvaginal finger- ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772594423000948

Modified technique for fluoroscopically guided pudendal ... Pudendal nerve blocks for pudendal neuralgia has been described as a safe and effective method for reducing pain for patients. Image guidance allows for ...

4. jag.journalagent.com jag.journalagent.com/anestezi/pdfs/JARSS_33_4_239_246.pdf

Fluoroscopy-Guided Pulsed Radiofrequency of the ... In this retrospective study, we evaluated the clinical outcomes and tolerability of fluoroscopy-guided pulsed radiofrequency applied to the ...

5. withpower.com withpower.com/trial/early-phase-1-neuralgia-5-2024-70525

Bupivacaine Injection for Pudendal Neuralgia This Phase 4 medical study run by University of Louisville is evaluating whether Bupivacaine will have tolerable side effects & efficacy for patients with ...

6. rapm.bmj.com rapm.bmj.com/content/37/3/262

Randomized Controlled Trial Comparing Pudendal Nerve ... The primary outcome was the success of the block in the distribution of the pudendal nerve along the perineum, rated as either absent, moderate, or strong.