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

Abstract

BackgroundUterine 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.MethodsThis 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.ResultsThe 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.ConclusionGiven 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.

Pelvic pain management with ultrasound-guided superior hypogastric plexus block (SHPB) after uterine artery embolization for symptomatic myomatosis

“…The addition of corticosteroids to SHPB increases the duration of analgesia after UAE 3,13,23,24 . Stewart JK et al 13 showed that adding triamcinolone to SHPB resulted in prolonged analgesia after UAE in 16 patients.…”

“…Visual analog scale (VAS): the initial VAS, reported immediately at the end of UAE, and the final VAS, between twelve and fourteen hours after SHPB and before discharge, were obtained. The scale was reported as mild (0-2), moderate (3)(4)(5)(6)(7), or severe (8-10) pain.…”

“…Normal myometrium remains viable through collateral circulation 1,2 . Subsequently, ischemic degeneration and regression of the myoma occur, resulting in uterine shrinkage and improvement or disappearance of symptoms such as pelvic pain, bleeding, and compression of adjacent organs 3 . Various embolizing materials have been used, such as gelatin sponge 4,5 , polyvinyl alcohol 1 , and microspheres 6 .…”

Retrospective Analysis of the Effect of Lidocaine Combined with Methylprednisolone on Pain Control After Uterine Artery Embolization

“…Methylprednisolone produces significant anti-inflammatory effects by inhibiting the NF-kB pathway and upregulating anti-inflammatory mediators ( 13 ). Glucocorticoids can inhibit the vascular and cellular phases of inflammation and release of BKs, and reduce the inflammatory response secondary to ischemic changes ( 26 ). However, the use of glucocorticoids can cause elevation of white blood cell levels, and the greater the dosage, the more obvious the increase in leukocyte levels the following day ( 27 ).…”

Managing Postembolization Syndrome–Related Pain after Uterine Fibroid Embolization

“…Studies have shown that glucocorticoids, particularly dexamethasone, are effective at reducing postoperative inflammation and pain in procedural settings. 25,26 Kim et al used 0.2 μg/kg/h dosing 30 minutes prior to UAE and 0.6 μg/kg/h 6 hours postprocedure. 27 In that study, the group that received dexamethasone required 28% less of the fentanyl PCA, had lower pain scores, and needed fewer analgesics than the control group.…”