A pilot study of the dose-response of caudal methylprednisolone with levobupivacaine in chronic lower back pain*

Abstract

SummaryThe question as to what constitutes the ideal epidural steroid injection remains unresolved. We performed a prospective, randomised, double-blind, AB ⁄ BA 2 · 2 crossover study of caudal 40 vs 80 mg methylprednisolone acetate (in 20 ml levobupivacaine 0.125%) in outpatients with chronic low back pain. Data from 33 participants were analysed. The Oswestry Disability Index improved in both dose groups over time following injection. However, a statistically significant improvement was only observed in the 40 mg methylprednisolone acetate group (40 mg: p < 0.001; 80 mg: p = 0.33). There was no statistically significant difference between the dose groups in change in the Oswestry Disability Index with respect to time. Methylprednisolone acetate 40 mg appears to be as effective as 80 mg in improving disability associated with chronic low back pain, and should be considered in preference to the 80 mg dose for outpatients with chronic low back pain attending for repeat caudal steroid injection.

Epidural Injections for Spinal Pain

“…In high-risk patients (e.g., patients with previous surgery) and procedures (e.g., cervical and thoracic transforaminal ESI) in which the inadvertent intravascular injection of depo-steroids can have catastrophic consequences such as paralysis and death, [117][118][119] physicians might consider removing steroids from the injectate and using nonsteroid solutions as a first-line treatment. Using nonsteroid solutions may also reduce the risk of rare but potentially fatal complications such as meningitis, which has recently been attributed to a contaminated steroid batch.# On the basis of these results and the results of other clinical trials demonstrating no differences between high-and lowdose ESI [110][111][112]120 the dose of steroids may be considerably reduced or even eliminated in high-risk patient populations. Examples of these patients might include individuals at high risk for avascular necrosis, 121 and those with diabetes, 122 at high risk for infection, 123 poor wound healing, or in whom the temporary suppression of the adrenocortical axis could adversely affect outcomes (e.g., those scheduled for major surgery).…”

“…In addition to the evidence presented here, several other randomized studies indirectly bolster this assertion. Randomized, doubleblind studies comparing high doses of steroid with lower doses in which the steroid was replaced by saline 110,111 or local anesthestic 112 have consistently failed to demonstrate any significant differences between treatment groups. A systematic review by Rabinovitch et al 113 found a statistically significant benefit for larger epidural injectate volumes irrespective of the contents, suggesting that the beneficial effect of nonsteroid solutions may counterbalance dilution of steroids.…”

“…27,132 For example, increasing the depo-steroid dose of more than 40 mg appears to provide no added benefit, and there is little evidence that a series of ESI results in better outcomes than a single injection, or tailoring the number of injections to patient response. 27,[110][111][112]120,132,133 However, the conglomeration of these different factors (e.g., injection type and number, dose, volume) may have a cumulative effect, and hence limit the generalization of the meta-analyses. Third, publication bias may be present for studies that compared ESI and ENSIs, with modeling suggesting a nonsignificant outcome favoring ESI when a correction for small study effects was performed.…”

“…In light of these findings, opportunities exist for clinicians and investigators to modify their approach to these procedures, such as reducing [110][111][112]120 or even in some cases eliminating, the steroid component of epidural injections in high-risk scenarios, and performing high-quality RCTs that directly compare epidural nonsteroid and nonepidural injections.…”

Cost effectiveness of epidural steroid injections to manage chronic lower back pain

“…Members of the study team obtained written informed consent from all study participants prior to randomization in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the ICH (International Conference on Harmonisation) Guideline for Good Clinical Practice. Full details of the trial’s organization and its clinical findings have been published elsewhere [20]. …”