← 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

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 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)

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

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,543 Previous Clinical Trials
4,249,014 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,554 Previous Clinical Trials
10,264,086 Total Patients Enrolled
1 Trials studying Adenomyosis
40 Patients Enrolled for Adenomyosis
Clayton Commander, MDPrincipal InvestigatorUniversity of North Carolina
1 Previous Clinical Trials
12 Total Patients Enrolled

Media Library

Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04126824 — Phase < 1
Adenomyosis Research Study Groups: Bupivacaine and Triamcinolone, Bupivacaine
Adenomyosis Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT04126824 — Phase < 1
Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04126824 — Phase < 1
~3 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top