Effect of Addition of Steroids on Duration of Analgesia

NCT04126824 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 21-001880
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Uterine Fibroids; Adenomyosis

Keywords

Uterine Artery Embolization

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Measure (mm)

  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

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

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; Other: Iohexol contrast

Bupivacaine and Triamcinolone

EXPERIMENTAL

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: Triamcinolone; Drug: Bupivacaine; Other: Iohexol contrast

Interventions

Triamcinolone DRUG

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

Also known as: Kenalog

Bupivacaine and Triamcinolone

Bupivacaine DRUG

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

Also known as: Marcaine, Exparel

Bupivacaine; Bupivacaine and Triamcinolone

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.

Also known as: Omnipaque

Bupivacaine; Bupivacaine and Triamcinolone

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (2)

University of California, Los Angeles

Westwood, Los Angeles, California, 90024, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Leiomyoma; Adenomyosis

Interventions

Triamcinolone; Triamcinolone Acetonide; Bupivacaine; Iohexol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jessica K Stewart, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 15, 2019
• Study Start: January 6, 2022
• Primary Completion (Estimated): August 2, 2026
• Study Completion (Estimated): August 2, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)