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Local Anesthetic
Bupivacaine Injection for Pudendal Neuralgia
Phase 4
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
Drug Has Already Been Approved
Pivotal Trial
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 belowSelect...
My pain or discomfort level is at least 4 out of 10.
Select...
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:Select...
I have not had pelvic surgery in the last 3 months.
Select...
I don't have skin or vaginal infections, allergies to bupivacaine, or blood clotting issues.
Select...
I have had a pudendal nerve block in the last 3 months.
Select...
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
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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 5 mL bupivacaine injected into bilateral pudendal nerves via fluoroscopic 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
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
348 Previous Clinical Trials
77,338 Total Patients Enrolled