The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy of single-dose dexamethasone in reducing post-embolization syndrome in patients undergoing uterine artery embolization

BACKGROUND: Uterine artery embolization (UAE) is a minimally invasive technique well established for treating symptomatic uterine fibroids. However, the post-procedure recovery for UAE involves a notable inflammatory process in response to ischemia known as post-embolization syndrome (PES). PES encompasses transient leukocytosis, low-grade fever, and can result in readmission of up to 10% of patients. In surgical settings, multiple studies have demonstrated the efficacy of glucocorticoids in reducing inflammation and associated pain. However, this approach has not yet been assessed in predominantly ischemia-driven PES. METHODS: This paper describes the protocol of a prospective randomized, double-blind, placebo-controlled, multi-center trial to test the efficacy and safety of single-dose dexamethasone on inflammatory responses, pain, nausea, and readmission rates after UAE. The study will enroll pre-menopausal patients between 25 and 55 years (planned enrollment, n = 60) with MRI confirmed symptomatic fibroids. Patients will be randomly allocated into two groups: single-dose intravenous dexamethasone plus standard of care or placebo (normal saline) plus standard of care. RESULTS: The primary endpoint is the patient pain score 4 h following the UAE procedure. Secondary endpoints include pain scores at 7 h and 24 h following UAE; narcotic usage in the first 24 h following UAE; and serum inflammatory markers (white blood cell count, C-reactive protein [CRP], interleukin-6 [IL-6], and cortisol) 24 h after UAE. CONCLUSION: Given the high incidence of post-procedure pain and difficulty with pain control after uterine artery embolization, results of this trial may directly influence the standard of care in perioperative management of patients undergoing UAE.