← Back to Search

Local Anesthetic

Steroid-Enhanced Nerve Block for Uterine Fibroids Pain Relief

Phase < 1

Waitlist Available

Led By Clayton Commander, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

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

Must have

Aged between 30 and 60 years

Be between 18 and 65 years old

Must not have

Diabetes mellitus

Contraindications to UAE

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 240 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding a corticosteroid to a nerve block improves pain relief and reduces narcotic use for women undergoing a uterine artery embolization.

Who is the study for?

This trial is for women aged 30-60 with painful uterine fibroids or adenomyosis who are scheduled for a Uterine Artery Embolization (UAE) procedure. It's not suitable for those with conditions making UAE unsafe, bleeding disorders, diabetes, allergies to anesthetics or steroids, and certain bowel diseases.

What is being tested?

The study tests if adding steroids to the Superior Hypogastric Nerve Block (SHNB), part of the UAE procedure, affects post-procedure pain and need for painkillers. Participants will receive SHNB with either Bupivacaine alone or combined with Triamcinolone.

What are the potential side effects?

Possible side effects include reactions at the injection site like pain or infection, steroid-related issues such as increased blood sugar levels (not relevant here due to diabetes exclusion), and potential nerve damage from the block procedure.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 30 and 60 years old.

Exclusion Criteria

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

Select...

I have diabetes.

Select...

I do not have any conditions that prevent me from undergoing UAE.

Select...

I have a history of inflammatory bowel disease or ulcerative colitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 240 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 240 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 240 hours for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Pain Intensity Measure (mm)

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

Active Control

Group I: Bupivacaine and TriamcinoloneExperimental Treatment3 Interventions

During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine plus triamcinolone mixed with contrast to enable visualization of the nerve block under fluoroscopy.

Group II: BupivacaineActive Control2 Interventions

During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine and contrast to enable visualization of the nerve block under fluoroscopy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Triamcinolone

2016

Completed Phase 4

~1220

Bupivacaine

2013

Completed Phase 4

~1530