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
Overview
- Phase
- Early Phase 1
- Intervention
- Bupivacaine
- Conditions
- Uterine Fibroids
- Sponsor
- University of California, Los Angeles
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Change in Pain Intensity Measure (mm)
- Status
- Active, Not Recruiting
- Last Updated
- 4 months ago
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.
Investigators
Jessica K. Stewart, MD
Principal Investigator
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
Bupivacaine
During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine and contrast to enable visualization of the nerve block under fluoroscopy.
Intervention: Bupivacaine
Bupivacaine
During the Uterine Artery Embolization (UAE) procedure, participants in this arm receive bupivacaine and contrast to enable visualization of the nerve block under fluoroscopy.
Intervention: Iohexol contrast
Bupivacaine and Triamcinolone
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.
Intervention: Triamcinolone
Bupivacaine and Triamcinolone
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.
Intervention: Bupivacaine
Bupivacaine and Triamcinolone
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.
Intervention: Iohexol contrast
Outcomes
Primary Outcomes
Change in Pain Intensity Measure (mm)
Time Frame: Baseline, 240 hours
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".