Effect of Addition of Steroids on Duration of Analgesia

December 10, 2025 updated by: Jessica K. Stewart, MD, University of California, Los Angeles

Prospective Randomized Controlled Clinical Trial: Superior Hypogastric Nerve Block for Pain Control After Uterine Artery Embolization: Effect of Addition of Steroids on Duration of Analgesia

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Investigators will enroll a total of 28 women undergoing the UAE procedure with 14 subjects in each study arm. This investigation is a single blind randomized control trial investigating the post-procedural analgesic effect of adding a corticosteroid (Triamcinolone) as an adjuvant to a SHNB that contains bupivacaine for patients undergoing UAE, compared to patients undergoing nerve block for pain control following UAE with local anesthetic only. Before and after the procedure, patients will be asked to complete online surveys in order to record their pain score (measured on the Visual Analog Pain Scale), opioid and other pain medication use, and other symptoms, such as nausea.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Westwood, Los Angeles, California, United States, 90024
        • University of California, Los Angeles
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 56 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • females
  • aged between 30 and 60 years
  • diagnosed with symptomatic uterine fibroids and/or adenomyosis and scheduled to undergo UAE procedure

Exclusion Criteria:

  • Contraindications to UAE
  • SHNB is deemed unsafe for the patient
  • Allergies to local anesthetic or steroid agent
  • History of inflammatory bowel disease or ulcerative colitis
  • Uncorrectable abnormal coagulation profile
  • Diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine
During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine and contrast to enable visualization of the nerve block under fluoroscopy.
Drug: Bupivacaine
0.5% bupivacaine (20 mL) administered as a Superior Hypogastric Nerve Block (SHNB).
Other Names:
  • Marcaine, Exparel
Other: Iohexol contrast
The appropriate amount of contrast to enable visualization of the nerve block under fluoroscopy given as a Superior Hypogastric Nerve Block (SHNB) will be administered.
Other Names:
  • Omnipaque
Experimental: Bupivacaine and Triamcinolone
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.
Drug: Bupivacaine
0.5% bupivacaine (20 mL) administered as a Superior Hypogastric Nerve Block (SHNB).
Other Names:
  • Marcaine, Exparel
Other: Iohexol contrast
The appropriate amount of contrast to enable visualization of the nerve block under fluoroscopy given as a Superior Hypogastric Nerve Block (SHNB) will be administered.
Other Names:
  • Omnipaque
Drug: Triamcinolone
40 mg triamcinolone administered as a Superior Hypogastric Nerve Block (SHNB)
Other Names:
  • Kenalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity Measure (mm)
Time Frame: Baseline, 240 hours
The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".
Baseline, 240 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Jessica K Stewart, MD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2022

Primary Completion (Estimated)

August 2, 2026

Study Completion (Estimated)

August 2, 2027

Study Registration Dates

First Submitted

October 7, 2019

First Submitted That Met QC Criteria

October 14, 2019

First Posted (Actual)

October 15, 2019

Study Record Updates

Last Update Posted (Estimated)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-001880 (Mayo Clinic in Florida)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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