MedDataX Logo

Effect of Addition of Steroids on Duration of Analgesia

NCT ID: NCT04126824

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-06

Study Completion Date

2027-08-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Fibroids Adenomyosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

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

Iohexol contrast

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Triamcinolone

Intervention Type DRUG

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

Bupivacaine

Intervention Type DRUG

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

Iohexol contrast

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Triamcinolone

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

Intervention Type DRUG

Bupivacaine

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

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Kenalog Marcaine, Exparel Omnipaque

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jessica K. Stewart, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jessica K Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, Los Angeles

Westwood, Los Angeles, California, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21-001880

Identifier Type: -

Identifier Source: org_study_id