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

Trial Summary

What is the purpose of this trial?

Chronic pain affecting the pelvic and urogenital area is a major clinical problem and can have a profound impact on quality of life and health care costs. Pelvic pain arising from entrapment or neuropathy of the pudendal nerve is known as pudendal neuralgia, which results in chronic perineal pain. This pain syndrome is difficult to diagnose and patients with pudendal neuralgia may present to providers with refractory chronic pelvic pain. Pudendal nerve infiltration or pudendal nerve block (PNB) serves as a diagnostic tool and treatment modality for patients with this condition. To date, there are no published randomized controlled trials comparing imaging-guided PNB to transvaginal finger-guided PNB. While one can assume that image-guided nerve blocks will provide better accuracy for injection and potentially better efficacy in pain relief as a result, no published data exists comparing the outcomes and efficacy between modalities. The purpose of this prospective, non-inferiority, randomized controlled trial is to compare the efficacy of pain relief from bilateral transvaginal finger-guided pudendal nerve block versus bilateral fluoroscopy-guided trans gluteal pudendal nerve block for patients with pudendal neuralgia.

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 data supports the effectiveness of the drug Bupivacaine for treating pudendal neuralgia?

Research on similar treatments, like CT-guided percutaneous infiltration using local anesthetics and corticosteroids, shows that these methods can safely and effectively reduce pain in conditions like Alcock's neuralgia, which is similar to pudendal neuralgia. This suggests that Bupivacaine, a local anesthetic, might also help relieve pain in pudendal neuralgia. ^{1 2 3 4 5}

Is Bupivacaine safe for treating pudendal neuralgia?

Bupivacaine, when used in pudendal nerve injections, is generally considered safe and provides rapid pain relief, although it is often combined with corticosteroids for longer-lasting effects. In studies, no complications were noted when steroids and local anesthetics like bupivacaine were administered within therapeutic doses. ^{1 3 6 7 8}

How does the drug Bupivacaine differ from other treatments for pudendal neuralgia?

Bupivacaine (Marcaine) is unique for its ability to provide a strong sensory block with minimal side effects, making it effective for pain relief in conditions like pudendal neuralgia. Its use in fractionated doses helps limit toxicity, and its high protein binding reduces the risk of affecting other areas, which may not be the case with other treatments. ^{9 10 11 12 13}

Eligibility Criteria

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.

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

Pregnant or intending to become pregnant during the study

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transsacral S2-S4 nerve block for vaginal pain due to pudendal neuralgia. [2011]

2. England pubmed.ncbi.nlm.nih.gov

Right laparoscopic pudendal release + neurostimulator prosthesis (LION procedure) in pudendal neuralgia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

CT-guided percutaneous infiltration for the treatment of Alcock's neuralgia. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Pilot Study Exploring Chronic Pudendal Neuromodulation as a Treatment Option for Pain Associated with Pudendal Neuralgia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Chronic perineal pain: analyses of prognostic factors in pudendal neuralgia. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Measuring the Quality of Pudendal Nerve Perineural Injections. [2019]

7. France pubmed.ncbi.nlm.nih.gov

[CT guided dual site infiltration in pudendal neuralgia]. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

10. Serbia pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]

11. United States 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. [2019]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine 0.25% and methylene blue spread with epidural anesthesia in dog. [2017]