Summary

Eligibility
for females ages 30-60 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Jessica K Stewart, MD (ucla)

Description

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.

Official 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

Details

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.

Keywords

Uterine Fibroids, Adenomyosis, Uterine Artery Embolization, Leiomyoma, Triamcinolone, Bupivacaine, Iohexol contrast, Bupivacaine and Triamcinolone

Eligibility

You can join if…

Open to females ages 30-60

You CAN'T join 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

Locations

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

Lead Scientist at University of California Health

  • Jessica K Stewart, MD (ucla)
    HS Assistant Clinical Professor, Radiological Sciences, Medicine. Authored (or co-authored) 5 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04126824
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 28 study participants
Last Updated