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Cumulative glucocorticoid exposure in patients receiving epidural steroid injections: A single-centre retrospective evaluation on 581 procedures against existing clinical recommendations.

ABSTRACT: The purpose of the study was to review the cumulative corticosteroid doses received from epidural and non-epidural-based pain interventions in a cohort of patients undergoing epidural steroid injections (ESIs) with comparison to safe dosing recommendations. Retrospective analysis was undertaken for all 349 patients who underwent a total of 581 ESIs at a single-centre, tertiary hospital in South Australia between 2017 and 2019. The primary outcome was the yearly dose analysis of cumulative steroid doses in methylprednisolone equivalents (MDPE) administered from epidural and non-epidural interventions in post-menopausal women, interpreted against maximum recommended doses. The annual limit of 200 mg for postmenopausal women was exceeded in 4.7% of the time (11/235) from ESIs alone, with a significant rise to 15.3% (46/300) when non-ESI injections were included in cumulative dose totals(p < 0.001). Of the 173 participants of post-menopausal female age, 4.1% (7/173) received cumulative corticosteroid doses above the 3-year 400 mg MPDE limit from ESIs alone, with a statistically significant increase to 13.9% (24/173) when non-epidural steroid injections were again included in cumulative dose totals (p < 0.001). The mean ± standard deviation administered MPDE per epidural steroid injection across the whole study cohort was 72 ± 22 mg, nearly double the recommended dose of 40 mg. Our study underpins the need for vigilance when considering steroid-based pain interventions, wherein both the individual and cumulative steroid exposure should be considered.

SUBMITTER: Brown-Beresford K

PROVIDER: S-EPMC11372952 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Cumulative glucocorticoid exposure in patients receiving epidural steroid injections: A single-centre retrospective evaluation on 581 procedures against existing clinical recommendations.

Brown-Beresford Kate K Wahba Medhat M Herriot Peter P Smithson-Tomas Georgia G Thiruvenkatarajan Venkatesan V

Interventional pain medicine 20220505 2

<h4>Background</h4>The purpose of the study was to review the cumulative corticosteroid doses received from epidural and non-epidural-based pain interventions in a cohort of patients undergoing epidural steroid injections (ESIs) with comparison to safe dosing recommendations.<h4>Methods</h4>Retrospective analysis was undertaken for all 349 patients who underwent a total of 581 ESIs at a single-centre, tertiary hospital in South Australia between 2017 and 2019. The primary outcome was the yearly ...[more]

PMID: 39239375

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Project description:BackgroundLumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, treatment of spinal stenosis symptoms remains controversial. Epidural steroid injections are used with increasing frequency as a less invasive, potentially safer, and more cost-effective treatment than surgery. However, there is a lack of data to judge the effectiveness and safety of epidural steroid injections for spinal stenosis. We describe our prospective, double-blind, randomized controlled trial that tests the hypothesis that epidural injections with steroids plus local anesthetic are more effective than epidural injections of local anesthetic alone in improving pain and function among older adults with lumbar spinal stenosis.MethodsWe will recruit up to 400 patients with lumbar central canal spinal stenosis from at least 9 clinical sites over 2 years. Patients with spinal instability who require surgical fusion, a history of prior lumbar surgery, or prior epidural steroid injection within the past 6 months are excluded. Participants are randomly assigned to receive either ESI with local anesthetic or the control intervention (epidural injections with local anesthetic alone). Subjects receive up to 2 injections prior to the primary endpoint at 6 weeks, at which time they may choose to crossover to the other intervention.Participants complete validated, standardized measures of pain, functional disability, and health-related quality of life at baseline and at 3 weeks, 6 weeks, and 3, 6, and 12 months after randomization. The primary outcomes are Roland-Morris Disability Questionnaire and a numerical rating scale measure of pain intensity at 6 weeks. In order to better understand their safety, we also measure cortisol, HbA1c, fasting blood glucose, weight, and blood pressure at baseline, and at 3 and 6 weeks post-injection. We also obtain data on resource utilization and costs to assess cost-effectiveness of epidural steroid injection.DiscussionThis study is the first multi-center, double-blind RCT to evaluate the effectiveness of epidural steroid injections in improving pain and function among older adults with lumbar spinal stenosis. The study will also yield data on the safety and cost-effectiveness of this procedure for older adults.Trial registrationClinicaltrials.gov NCT01238536.

Project description:BackgroundTransforaminal epidural injections with steroids (TESI) are increasingly being used in patients sciatica. The STAR (steroids against radiculopathy)-trial aimed to evaluate the (cost-) effectiveness of TESI in patients with acute sciatica (< 8 weeks). This article contains the economic evaluation of the STAR-trial.MethodsParticipants were randomized to one of three study arms: Usual Care (UC), that is oral pain medication with or without physiotherapy, n = 45); intervention group 1: UC and transforaminal epidural steroid injection (TESI) 1 ml of 0.5% Levobupivacaine and 1 ml of 40 mg/ml Methylprednisolone and intervention group 2: UC and transforaminal epidural injection (TEI) with 1 ml of 0,5% Levobupivacaine and 1 ml of 0.9% NaCl (n = 50). The primary effect measure was health-related quality of life. Secondary outcomes were pain, functioning, and recovery. Costs were measured from a societal perspective, meaning that all costs were included, irrespective of who paid or benefited. Missing data were imputed using multiple imputation, and bootstrapping was used to estimate statistical uncertainty.ResultsNone of the between-group differences in effects were statistically significant for any of the outcomes (QALY, back pain, leg pain, functioning, and global perceived effect) at the 26-weeks follow-up. The adjusted mean difference in total societal costs was €1718 (95% confidence interval [CI]: - 3020 to 6052) for comparison 1 (intervention group 1 versus usual care), €1640 (95%CI: - 3354 to 6106) for comparison 2 (intervention group 1 versus intervention group 2), and €770 (95%CI: - 3758 to 5702) for comparison 3 (intervention group 2 versus usual care). Except for the intervention costs, none of the aggregate and disaggregate cost differences were statistically significant. The maximum probability of all interventions being cost-effective compared to the control was low (< 0.7) for all effect measures.ConclusionThese results suggest that adding TESI (or TEI) to usual care is not cost-effective compared to usual care in patients with acute sciatica (< 8 weeks) from a societal perspective in a Dutch healthcare setting.Trial registrationDutch National trial register: NTR4457 (March, 6th, 2014).

Project description:ObjectiveTo evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy.DesignA multicenter randomized study conducted between 2011 and 2014. Computer generated randomization was stratified by site. Patients and evaluating physicians were blinded to treatment outcomes.SettingsEight military, Veterans Administration, and civilian hospitals.Participants145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain.InterventionsParticipants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin.Main outcome measuresAverage leg pain one and three months after the injection on a 0-10 numerical rating scale. A positive outcome was defined as a ≥ 2 point decrease in leg pain coupled with a positive global perceived effect. All patients had one month follow-up visits; patients whose condition improved remained blinded for their three month visit.ResultsThere were no significant differences for the primary outcome measure at one month (mean pain score 3.3 (SD 2.6) and mean change from baseline -2.2 (SD 2.4) in epidural steroid injection group versus 3.7 (SD 2.6) and -1.7 (SD 2.6) in gabapentin group; adjusted difference 0.4, 95% confidence interval -0.3 to 1.2; P=0.25) and three months (mean pain score 3.4 (SD 2.7) and mean change from baseline -2.0 (SD 2.6) versus 3.7 (SD 2.8) and -1.6 (SD 2.7), respectively; adjusted difference 0.3, -0.5 to 1.2; P=0.43). Among secondary outcomes, one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain (-3.0, SD 2.8) than those treated with gabapentin (-2.0, SD 2.9; P=0.04) and were more likely to experience a positive successful outcome (66% v 46%; number needed to treat=5.0, 95% confidence interval 2.8 to 27.0; P=0.02). At three months, there were no significant differences between treatments.ConclusionsAlthough epidural steroid injection might provide greater benefit than gabapentin for some outcome measures, the differences are modest and are transient for most people.Trial registration ClinicalTrials.gov Identifier: NCT01495923.

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Cumulative glucocorticoid exposure in patients receiving epidural steroid injections: A single-centre retrospective evaluation on 581 procedures against existing clinical recommendations.

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Cumulative glucocorticoid exposure in patients receiving epidural steroid injections: A single-centre retrospective evaluation on 581 procedures against existing clinical recommendations.

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