Effect of Addition of Steroids on Duration of Analgesia

Study Overview
=================
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.

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

Conditions
-----------------
Uterine Fibroids, Adenomyosis

Intervention / Treatment
-----------------
* Drug: Triamcinolone
* Drug: Bupivacaine
* Other: Iohexol contrast


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine<br>During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine and contrast to enable visualization of the nerve block under fluoroscopy. | Drug: Bupivacaine<br>* 0.5% bupivacaine (20 mL) administered as a Superior Hypogastric Nerve Block (SHNB).<br>* Other names: Marcaine, Exparel;Other: Iohexol contrast<br>* 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.<br>* Other names: Omnipaque;|
| Experimental: Bupivacaine and Triamcinolone<br>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. | Drug: Triamcinolone<br>* 40 mg triamcinolone administered as a Superior Hypogastric Nerve Block (SHNB)<br>* Other names: Kenalog;Drug: Bupivacaine<br>* 0.5% bupivacaine (20 mL) administered as a Superior Hypogastric Nerve Block (SHNB).<br>* Other names: Marcaine, Exparel;Other: Iohexol contrast<br>* 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.<br>* Other names: Omnipaque;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uterine Artery Embolization