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Local Anesthetic

Bupivacaine Injection for Pudendal Neuralgia

Phase < 1

Recruiting

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Minimum pain/bother score of 4/10

Diagnosis of pudendal neuralgia OR chronic pelvic pain with pain in the distribution of the pudendal nerve for 3 months or longer

Must not have

Pelvic surgery within the last 3 months

Contraindication to pudendal nerve block (skin or vaginal infection, bupivacaine allergy, uncorrected coagulopathy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare two methods of treating chronic pelvic pain caused by pudendal neuralgia. One method involves a transvaginal finger-guided pudendal nerve block, while the other

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include discomfort at injection site, allergic reactions to bupivacaine, temporary numbness in the pelvic region, bleeding, infection risk at the puncture site, and potential worsening of symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have had a pudendal nerve block in the last 3 months.

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I have a neurological condition affecting my lower body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absolute change in Visual Analog Scale (VAS) for pain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Transvaginal pudendal nerve blockExperimental Treatment1 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 blockExperimental Treatment1 Intervention

Participants in this arm will receive 10 mL bupavicaine injected into bilateral pudendal nerves via fluoroscopy-guided trans gluteal approach. They will receive one injection over the 6 week duration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine injection

2024

N/A

~70

0 / 6Eligibility criteria met