Brief Title
Effect of Addition of Steroids on Duration of Analgesia
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
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.
Detailed 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.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Change in Pain Intensity Measure (mm)
Condition
Uterine Fibroids
Intervention
Triamcinolone
Study Arms / Comparison Groups
Bupivacaine
Description: During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine and contrast to enable visualization of the nerve block under fluoroscopy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
28
Start Date
November 5, 2019
Completion Date
February 2025
Primary Completion Date
February 2024
Eligibility Criteria
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
Gender
Female
Ages
30 Years - 60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jessica K Stewart, MD, 310-794-9202, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04126824
Organization ID
21-001880
Responsible Party
Principal Investigator
Study Sponsor
University of California, Los Angeles
Study Sponsor
Jessica K Stewart, MD, Principal Investigator, University of California, Los Angeles
Verification Date
March 2022