The risk of rare, but potentially serious, neurological damage from epidural steroid injections (ESIS) can be greatly reduced if anesthetists and other physicians follow certain specific safety measures. This is what is reported in an article published in the journal Anestesiology and which derives from a consensus panel representing 13 medical organizations in collaboration with the FDA.
Epidural corticosteroid injections are a common treatment for pain caused by herniated intervertebral radicular disc, spinal stenosis, and other disorders. These injections are associated with a number of minor complications and side effects, such as exacerbation of pain, vasovagal reaction, headache and accidental dural puncture that do not involve any permanent damage.
Catastrophic neurological injuries have rarely occurred, including stroke and spinal cord injury, sometimes even death.
To try to address this problem, a collaboration was created between the FDA’s Safe Use Initiative, a multidisciplinary working group of experts and 13 companies of stakeholder specialists.
The goal of this collaboration was to review existing evidence regarding neurological complications associated with epidural corticosteroid injections and produce a consensus document with clinical procedural considerations aimed at improving the safety of these injections.
Representatives from the FDA helped convene and facilitate meetings without actively participating in deliberations or decision making.
17 clinical considerations aimed at improving safety were produced. Specific clinical considerations have been issued for performing transforaminal and interlaminar injections, including the use of non-particulate steroids, anatomical considerations, and
Panel experts said: “We recognize that severe neurological injury can and does occur during epidural steroid injections. The actual incidence is unknown, but epidural steroid injections are common and relationships with these neurological injuries are rare.
The purpose of this multidisciplinary effort was to review the available evidence and assemble the best clinical considerations to reduce or eliminate these injuries. ”
Group members represent a wide range of specialists, including anesthetists, pain medicine specialists, surgeons orthopedists, interventional radiologists and physical medicine and rehabilitation specialists
Of the 17 specific recommendations, 10 were accepted by all 13 organizations.
For example, all groups agreed on the following: operators must wear sterile masks and gloves during the procedure; all cervical and interlaminar injections should be done under image guidance; Interlaminar cervical epidural steroid (ESI) infiltrations are recommended from the C7 vertebra to T1, but preferably not supra to C6-C7.
The experts also agreed that no interlaminar cervical ESI should be performed at any segmental level without ensuring, via imaging studies, that there is sufficient epidural space for needle placement, and the treating physician must make the final choice of a interlaminar or transforaminal technique weighing risks and potential benefits, with each technique for a given patient.
Other recommendations won agreement from at least 11 of the 13 organizations.
Although the initial use of non-particulate steroid dexamethasone in lumbar transforaminal injections was recommended (11 out of 13 votes), representatives unanimously agreed that there may be instances where particulate steroids could be used in this context; for example, consider a particulate steroid when a given patient has not improved after initial treatment with non-particulate steroids.
Two organizations failed to agree on whether cervical and lumbar interlaminar ESI can be performed without contrast in patients with contrast allergy or anaphylactic reactions.
Overall, however, the recommendations reflect a strong majority opinion on best practice.
In an accompanying editorial, Brian Thomas Bateman and Gary J. Brenner of the Department of Anesthesia, Critical Care, and Pain Medicine at Massachusetts General Hospital in Boston, call for research into the causes and prevention of ESI-associated injuries: of consensus by the working group is an important step forward for pain medicine, but it is essential to carry out studies that better clarify the risks of ESI, to further refine the group’s suggestions ”.
The editorial specifies that: “The annual number of epidural injections performed has nearly doubled since 2000. In 2012 alone, there were over 2 million ESI applications filed for Medicare (US government administered medical insurance program).” .
However, the true incidence of catastrophic complications is unknown because prospective studies have not been done.
The editorialists call for a better understanding of the factors that can contribute to the risk of severe ESI neurological injury, such as patient-specific, pharmacological, technical factors: “We also need to understand the effect on underlying risk and physician training perform this procedure, especially the number of practitioners who perform ESI have not completed a formal pain scholarship. ”
In conclusion, adherence to specific recommended practices when performing epidural corticosteroid injections should lead to a reduction in the incidence of neurological lesions.
Roidex 