Obstetrics & Gynecology · Medical Literature
Intraarterial Dexamethasone for Pain Relief After Uterine Fibroid Embolization: A Randomized Clinical Trial.
Abstract
Acute postprocedural pain remains a major barrier to uterine fibroid embolization (UFE). To assess whether intraarterial dexamethasone reduces postprocedural pain after UFE. This double-blind, placebo-controlled randomized clinical trial was conducted from July 2020 to December 2023, with follow-up through 3 months, at a single tertiary academic medical center. Participants were women, aged 20 to 50 years, undergoing UFE. Intraarterial dexamethasone (10 mg) or saline placebo administered during embolization. The primary outcome was postprocedural pain through 168 hours. Secondary outcomes included postembolization syndrome symptoms; fibroid-related symptoms and health-related quality of life, assessed using the UFE-Quality of Life questionnaire at baseline and at 1 and 3 months; and percentage reduction in uterine volumes on magnetic resonance imaging. Among 42 women randomized (mean [SD] age, 44.7 [4.7] years; 21 per group), 40 women were included in the final analysis (20 randomized to the dexamethasone group and 20 to the placebo group) after excluding 2 participants. In the dexamethasone group, 7 participants (35%) were African American, 6 (30%) were Hispanic, and 7 (35%) were White; in the placebo group, 9 (45%) were African American, 8 (40%) were Hispanic, and 3 (15%) were White. Intraarterial dexamethasone was associated with significantly lower mean (SD) pain scores immediately after the procedure (4.0 [3.3] vs 6.1 [3.1]; mean difference, -2.1 [95% CI, -4.14 to -0.06]; P = .04) and through 96 hours (2.4 [2.4] vs 4.5 [3.2]; mean difference, -2.1 [95% CI, -3.90 to -0.30]; P = .02) compared with placebo. The mean (SE) pain score over 168 hours was significantly lower in the dexamethasone group vs placebo (2.63 [2.28] vs 4.28 [2.27] visual analog scale units; mean difference, -1.64 [95% CI, -3.10 to -0.19]; P = .02). Among participants with paired magnetic resonance imaging follow-up, the mean (SD) uterine volume reduction from baseline to 3 months was 37.4% (17.7%) in the dexamethasone group vs 29.6% (20.2%) in the placebo group (P = .30), and the mean (SD) dominant fibroid volume reduction was 34.4% (22.8%) vs 38.6% (16.7%) (P = .60). No major complications occurred in either group. In this randomized clinical trial of 40 women undergoing UFE, intraarterial dexamethasone was associated with clinically meaningful reductions in postprocedural pain through 96 hours compared with placebo, without compromising treatment efficacy or increasing adverse events, which may offer a simple, low-cost strategy to reduce analgesic burden in individuals undergoing UFE. ClinicalTrials.gov Identifier: NCT04655144.
Clinical relevance
Acute postprocedural pain following uterine fibroid embolization (UFE) is a well-recognized barrier to wider adoption of this minimally invasive uterine-sparing procedure, often necessitating prolonged opioid analgesia and inpatient admission. This trial addresses a critical unmet need in the management of postembolization syndrome in reproductive-aged women (20–50 years), a population in whom opioid-sparing strategies are highly desirable. The findings are immediately clinically relevant given the simplicity, low cost, and favorable safety profile of intraarterial dexamethasone as an adjunct analgesic intervention.
Key findings
1. Intraarterial dexamethasone (10 mg) was associated with significantly lower mean pain scores immediately post-procedure compared with placebo (4.0 vs 6.1 on VAS; mean difference −2.1 [95% CI, −4.14 to −0.06]; P = .04). 2. Mean pain scores through 96 hours were significantly lower in the dexamethasone group vs placebo (2.4 vs 4.5; mean difference −2.1 [95% CI, −3.90 to −0.30]; P = .02). 3. The mean pain score over the full 168-hour follow-up period was significantly lower with dexamethasone vs placebo (2.63 vs 4.28 VAS units; mean difference −1.64 [95% CI, −3.10 to −0.19]; P = .02). 4. Uterine volume reduction at 3 months was numerically greater in the dexamethasone group (37.4% ± 17.7%) vs placebo (29.6% ± 20.2%), but this difference was not statistically significant (P = .30), indicating no compromise of treatment efficacy. 5. Dominant fibroid volume reduction at 3 months did not differ significantly between groups (dexamethasone 34.4% ± 22.8% vs placebo 38.6% ± 16.7%; P = .60), further confirming preserved embolization efficacy. 6. No major complications occurred in either group, supporting the safety of intraarterial dexamethasone in this patient population. Note: NNT, NNH, and health-related quality of life outcome data (UFE-QoL) were not reported with sufficient quantitative detail in the abstract to include here.
Practice implications
Interventional radiologists and gynecologists performing UFE should consider administering intraarterial dexamethasone 10 mg at the time of embolization as a simple, low-cost adjunct to standard periprocedural analgesia, given its demonstrated reduction in postprocedural pain through 96 hours without compromising fibroid treatment efficacy or increasing adverse events. This strategy may reduce reliance on opioid analgesics in the acute postembolization period, potentially facilitating same-day discharge or shorter observation stays in appropriately selected patients. Larger multicenter trials are warranted to confirm these findings, define optimal dosing, and assess the impact on opioid consumption and quality-of-life outcomes across diverse patient populations.