Steroid-Enhanced Nerve Block for Uterine Fibroids Pain Relief

Recruiting at 1 trial location

Overseen By Saima Chaabane

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of the study is to investigate the differences in post-procedural pain scores and narcotic use among patients who receive a Superior Hypogastric Nerve Block (SHNB) with and without corticosteroid performed as part of the Uterine Artery Embolization (UAE) procedure.

Research Team

Jessica K Stewart, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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.

Inclusion Criteria

I am between 30 and 60 years old.

I am female.

I am diagnosed with uterine fibroids or adenomyosis and will have a UAE procedure.

Exclusion Criteria

My doctor says a nerve block is unsafe for me.

I have diabetes.

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

Treatment Details

Interventions

• Bupivacaine (Local Anesthetic)
• Triamcinolone (Corticosteroid)

Trial Overview 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.

Participant Groups

Group I: Bupivacaine and Triamcinolone Experimental Treatment 3 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: Bupivacaine Active Control 2 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.

Bupivacaine is already approved in Canada for the following indications:

Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+