Dexamethasone for Post Uterine Artery Embolization Pain

Study Overview
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Brief Summary
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The purpose of this research is to investigate if administration steroids (anti-inflammatory medication) via the uterine arteries during uterine fibroid embolization (A non surgical procedure for treating uterine fibroids by blocking their blood supply) can help reduce the pain, nausea, vomiting, and general feeling of weakness following the procedure.

Official Title
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Intra-Arterial Dexamethasone for the Alleviation of Pain and Postembolization Syndrome Following Uterine Artery Embolization

Conditions
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Leiomyoma

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who meet criteria to undergo uterine fibroid embolization for symptomatic fibroids. Exclusion Criteria: Currently pregnant or actively attempting to conceive Those deemed mentally impaired to make their own medical decisions Previous documented allergy to dexamethasone Those currently taking daily steroids for any reason Those with diabetes or deemed to be pre-diabetic Those with contraindications for angiography Prisoners

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone Arm<br>A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization. | Drug: Dexamethasone<br>* Dexamethasone delivered to the uterine arterial bed, prior to embolization.<br>|
| Placebo Comparator: Saline Arm<br>A volume of normal saline, equal to the total volume delivered in the Dexamethasone Arm, will be administered into each uterine artery prior to uterine artery embolization. | Drug: Saline<br>* Saline delivered to the uterine arterial bed, prior to embolization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores using the VAS Questionnaire | Pain is measured using a modified Visual Analogue Score (VAS), which has a total score ranging from 0 (no pain at all) to 10 (worst pain). | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of post-embolization syndrome symptoms | Post embolization Syndrome (PES) symptomatology will be assessed using a PES survey | Day 7 | 
| Change in uterine fibroid volume | As evaluated via magnetic Resonance Imaging (MRI) using volumetric software | Baseline, 3 months | 
| Change in symptoms | Change in participant symptoms will be assessed using the Uterine Fibroid Embolization (UFE) Quality of Life and Symptomatology Survey with a total subsection score ranging from 8-40 with the higher score indicating a patient-perceived improvement in symptomatology. | Baseline, 3 months | 
| Change in quality of life | Change in participant quality of life will be reported using the Uterine Fibroid Embolization (UFE) Quality of Life and Symptomatology Survey with a total subsection score ranging from 0-6 with the highest score indicating the best positive response. | Baseline, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexamethasone, Fibroids, Leiomyoma, post-embolization pain