Panel Recommends Steps for Safer Epidural Injections

Neil Osterweil

February 13, 2015

The risk for rare but potentially catastrophic neurological injuries from epidural steroid injections (ESIs) can be substantially reduced if anesthesiologists and other clinicians follow specific safety measures, according to members of a consensus panel representing 13 national medical organizations.

"We acknowledge that catastrophic neurologic injuries can and do occur during epidural steroid injections. The actual incidence is unknown, but epidural steroid injections are common and reports of these neurologic injuries are uncommon. The purpose of this multidisciplinary effort was to review the available evidence and assemble the best clinical considerations for reducing or eliminating these injuries," the panelists write in an article published online February 9 in Anesthesiology.

Panel members represent a wide range of specialists, including anesthesiologists, pain medicine specialists, orthopedic surgeons, interventional radiologists, and physical medicine and rehabilitation specialists. Panel meetings were facilitated by the US Food and Drug Administration's Safe Use Initiativesocieties.

17 Items

The panelists arrived at 17 specific recommendations, 10 of which all 13 organizations agreed to.

For example, all groups agreed on the following:

  • practitioners must wear face masks and sterile gloves during the procedure,

  • all cervical and lumber interlaminar injections should be performed under image guidance,

  • cervical interlaminar ESIs are recommended at vertebrae C7 to T1, but preferably not higher than the C6 to C7 level,

  • no cervical interlaminar ESIs should be performed at any segmental level without ensuring via imaging studies that there is adequate epidural space for placement of the needle, and

  • the treating physician should make the ultimate choice of an interlaminar or transforaminal technique and should be made by weighing potential risks and benefits with each technique for a given patient.

Other recommendations received a majority of agreement from no fewer than 11 of the 13 organizations. For example, two groups were unable to reach consensus on whether a non-particulate such as dexamethasone should be used in initial lumbar transforaminal injections, and two could not decide whether cervical and lumbar interlaminar ESI can be performed without contrast in patients with contrast allergy or anaphylactic reactions.

On the whole, however, the recommendations reflect a strong majority opinion about optimal clinical practices.

A Good Start, But...

In an accompanying editorial, Brian Thomas Bateman, MD, MSc, and Gary J. Brenner, MD, PhD, from the Department of Anesthesia, Critical Care, and Pain Medicine at Massachusetts General Hospital in Boston, call for research into the causes and prevention of injuries associated with well-intentioned ESIs.

"While the Working Group's consensus statement is an important step forward for pain medicine, it is essential that as a field we perform the studies that will better elucidate the risks of [ESI], to further refine the Group's suggestions," they write.

They note that "[t]he annual number of epidural injections performed on Medicare beneficiaries has approximately doubled since 2000; in 2012 alone there were over 2 million claims submitted to Medicare for ESIs." However, the true incidence of the catastrophic complications is unknown because prospective studies have not been done.

The editorialists call for better understanding of factors that may contribute to risk for serious neurological injuries from ESI, such as patient-specific, technical, and pharmacologic factors.

"We need to also understand the effect on risk of the background and training of the clinicians performing the procedure, particularly as many practitioners performing ESIs have not completed a formal pain fellowship," they write.

The consensus statement was supported by the US Food and Drug Administration and by institutions or organizations of the panel members. One coauthor reported acting as a consultant to Medtronics, Mesoiblast, and Relievant MedSystems. He also holds stock in Nocimed and Relievant. Another coauthor reported receiving grants and/or research support from AOSpine, Cerapedics, Medtronic, OREF, and Spinal Dynamics and receives honoraria from New England Spine Society Group and NASS. He also receives royalties from Biomet, Medtronic, and Osprey and is a stock holder with Amedica, Benvenue, Expanding Orthopedics, Nexgen Spine, Osprey, Pardigm, Spine, Spinal Kinetics, Spineology, Vertiflex, PSD.

Anesthesiology. Published online February 9, 2015. Article full text, Editorial full text

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