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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04126824
Other study ID # 21-001880
Secondary ID
Status Active, not recruiting
Phase Early Phase 1
First received
Last updated
Start date January 6, 2022
Est. completion date February 2026

Study information

Verified date May 2024
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 28
Est. completion date February 2026
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Triamcinolone
40 mg triamcinolone administered as a Superior Hypogastric Nerve Block (SHNB)
Bupivacaine
0.5% bupivacaine (20 mL) administered as a Superior Hypogastric Nerve Block (SHNB).
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.

Locations

Country Name City State
United States University of North Carolina Chapel Hill North Carolina
United States University of California, Los Angeles Westwood California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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