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OpenTrials
Active, Not Recruiting

NCT Number: NCT04126824

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Uterine Fibroids Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Urogenital Diseases Uterine Diseases

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of California, Los Angeles, Westwood, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triamcinolone

Drug

40 mg triamcinolone administered as a Superior Hypogastric Nerve Block (SHNB)

Other names: Kenalog

Bupivacaine

Drug

0.5% bupivacaine (20 mL) administered as a Superior Hypogastric Nerve Block (SHNB).

Other names: Marcaine, Exparel

Iohexol contrast

Other

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

Primary outcomes

  1. 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".

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Oct 15, 2019
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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