Scott E. Glaser, M.D., DABIPP

Needle position analysis in cases of paralysis from transforaminal epidurals: consider alternative approaches to traditional technique.

Abstract

BACKGROUND: Transforaminal technique for epidural steroid injections, unlike other approaches, is uniquely associated with permanent, bilateral, lower extremity paralysis.

OBJECTIVE: To review the literature and analyze the reported cases of paralysis from lumbar transforaminal epidural steroid injections to possibly establish a cause and to prevent this complication.

STUDY DESIGN: Eighteen cases of paralysis from transforaminal epidural injection have been reported. We could analyze the position of the needle within the neural foramen based on the available images and/or description among 10 of these 18 cases. Five cases were performed with computed tomography guidance and 12 cases were performed with fluoroscopic guidance unknown in one case. Additionally, other variables associated with the procedure, including the technique, were also examined.

METHODS: Analysis of the needle position in the neural foramen in cases of paralysis from transforaminal epidural steroid injections. This analysis is based on images and/or description provided in published reports.

RESULTS: Paralysis in these cases seems to be associated with a well performed traditional safe triangle approach with good epidural contrast spreads. Analyzed data shows that 77.7% of the time, the needle was in the superior part of the foramen. In 71.4% of the cases, the needle was in the anterior part of the foramen. This coincides with the location of the radicular artery in the foramen. In 22.2%, the needle was in the midzone (neither in the superior nor inferior zone). No level was spared as this event occurred at every foramen from T12 to S1. Ten of these events happened during a left-sided procedure and 8 during a right-sided procedure. No relation to this complication was noted when other variables like type and size of the needles, side of the injection, local anesthetic, contrast, or volume of injectate were taken into consideration.

LIMITATIONS: Only 18 cases of paralysis from transforaminal epidurals have been reported. Out of these, only 10 cases included images or descriptions which could be evaluated for our study.

CONCLUSION: In light of the anatomical and radiological evidence in the literature that radicular arteries dwell in the superior part of the foramen and along with our needle position analysis, we suggest that the traditional technique of placing the needle in the superior and anterior part of the foramen must be reexamined. Alternative, safer techniques must be considered, one of which is described.

Paraplegia following a thoracolumbar transforaminal epidural steroid injection.

BACKGROUND: In recent years, transforaminal epidural injections have emerged as an alternative to interlaminar and caudal epidural steroid injections. The rationale for utilizing transforaminal epidural injections has been described for diagnostic as well as therapeutic purposes. The evidence for lumbar transforaminal epidural steroid injections in managing lumbar nerve root pain is strong, whereas it is moderate in managing cervical nerve root pain. However, these techniques are also associated with rare, but catastrophic, neurologic complications.

OBJECTIVE: To present a case report describing a devastating neurologic injury following a transforaminal thoracolumbar epidural steroid injection.

CASE REPORT: A 67-year-old female was referred for treatment of chest wall pain following a T-12 compression fracture. Her pain was primarily radicular in nature. She had not responded to conservative care and continued to suffer from disabling pain. A left T12-L1 transforaminal epidural steroid injection was performed using the “safe triangle” technique; there was appropriate spread of dye that was visualized and recorded as well as a “washout” image. The injectate consisted of a 3 mL volume of 1% ropivacaine and 50 mg triamcinolone acetonide suspension. The patient experienced a rapid and complete loss of sensation and movement below the T-10 level within five minutes after the injection. An MRI initially performed six hours after the procedure was non-diagnostic but an MRI performed two days later confirmed a thoracolumbar spinal cord infarction. High dose intravenous steroids provided during the course of treatment did not significantly alter her neurological deficits and she continues to be paraplegic.

CONCLUSION: This case report describes vascular injury leading to an infarction of the spinal cord following a thoracolumbar transforaminal epidural steroid injection. Alternative approaches to, or alternatives means of, performing transforaminal injections should be considered to avoid devastating neurological complications.

Opioid complications and side effects.

Medications which bind to opioid receptors are increasingly being prescribed for the treatment of multiple and diverse chronic painful conditions. Their use for acute pain or terminal pain is well accepted. Their role in the long-term treatment of chronic noncancer pain is, however, controversial for many reasons. One of the primary reasons is the well-known phenomenon of psychological addiction that can occur with the use of these medications. Abuse and diversion of these medications is a growing problem as the availability of these medications increases and this public health issue confounds their clinical utility. Also, the extent of their efficacy in the treatment of pain when utilized on a chronic basis has not been definitively proven. Lastly, the role of opioids in the treatment of chronic pain is also influenced by the fact that these potent analgesics are associated with a significant number of side effects and complications. It is these phenomena that are the focus of this review. Common side effects of opioid administration include sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression. Physical dependence and addiction are clinical concerns that may prevent proper prescribing and in turn inadequate pain management. Less common side effects may include delayed gastric emptying, hyperalgesia, immunologic and hormonal dysfunction, muscle rigidity, and myoclonus. The most common side effects of opioid usage are constipation (which has a very high incidence) and nausea. These 2 side effects can be difficult to manage and frequently tolerance to them does not develop; this is especially true for constipation. They may be severe enough to require opioid discontinuation, and contribute to under-dosing and inadequate analgesia. Several clinical trials are underway to identify adjunct therapies that may mitigate these side effects. Switching opioids and/or routes of administration may also provide benefits for patients. Proper patient screening, education, and preemptive treatment of potential side effects may aid in maximizing effectiveness while reducing the severity of side effects and adverse events. Opioids can be considered broad spectrum analgesic agents, affecting a wide number of organ systems and influencing a large number of body functions.

Effectiveness of opioids in the treatment of chronic non-cancer pain.

For thousands of years, opioids have been used to treat pain, and they continue to be one of the most commonly prescribed medications for pain. It is estimated that 90% of patients presenting to pain centers and receiving treatment in such facilities are on opioids. Opioids can be considered broad-spectrum analgesics that act at multiple points along the pain pathway. Unfortunately, opioids also have the potential for great harm, with multiple side effects and potential complications, some of which are lethal. They are also uniquely addictive, which can lead to misuse and diversion. We reviewed the relevant English literature and did thorough manual searches of the bibliographies of known primary and review articles. We utilized pain relief as the primary outcome measure. Other outcome measures were functional improvement, improvement of psychological status, improvement in work status, and evidence of addiction. Short-term use and improvement was defined as less than 6 months and long-term relief was defined as 6 months or longer. The 3 systematic reviews evaluating long-term effectiveness of opioids for chronic non-cancer pain provided unclear and weak evidence. The results of this review showed that many patients in the included studies were dissatisfied with adverse events or insufficient pain relief from opioids and withdrew from the studies. For patients able to continue on opioids, evidence was weak suggesting that their pain scores were lower than before therapy and that this relief could be maintained long-term (> 6 months). There was also weak evidence that long-term opioid therapy with morphine and transdermal fentanyl not only decreases pain but also improves functioning. Limited evidence was available for the most commonly used opioids, oxycodone and hydrocodone. Evidence for the ability to drive on chronic opioid therapy was moderate without major side effects or complications. It is concluded that, for long-term opioid therapy of 6 months or longer in managing chronic non-cancer pain, with improvement in function and reduction in pain, there is weak evidence for morphine and transdermal fentanyl. However, there is limited or lack of evidence for all other controlled substances, including the most commonly used drugs, oxycodone and hydrocodone.

Opioids in the management of chronic non-cancer pain: an update of American Society of the Interventional Pain Physicians’ (ASIPP) Guidelines.

BACKGROUND: Opioid abuse has continued to increase at an alarming rate since our last opioid guidelines were published in 2005. Available evidence suggests a continued wide variance in the use of opioids, as documented by different medical specialties, medical boards, advocacy groups, and the Drug Enforcement Administration.

OBJECTIVES: The objectives of opioid guidelines by the American Society of Interventional Pain Physicians (ASIPP) are to provide guidance for the use of opioids for the treatment of chronic non-cancer pain, to bring consistency in opioid philosophy among the many diverse groups involved, to improve the treatment of chronic non-cancer pain, and to reduce the incidence of abuse and drug diversion.

DESIGN: A broadly based policy committee of recognized experts in the field evaluated the available literature regarding opioid use in managing chronic non-cancer pain. This resulted in the formulation of the review and update of the guidelines published in 2006, a series of potential evidence linkages representing conclusions, followed by statements regarding the relationships between clinical interventions and outcomes.

METHODS: The elements of the guideline preparation process included literature searches, literature synthesis, consensus evaluation, open forum presentations, formal endorsement by the Board of Directors of the American Society of Interventional Pain Physicians, and peer review. Based on the criteria of the U.S. Preventive Services Task Force, the quality of evidence was designated as Level I, II, and III, with 3 subcategories in Level II, with Level I described as strong and Level III as indeterminate. The recommendations were provided from 1A to 2C, varying from strong recommendation with high quality evidence to weak recommendation with low-quality or very low-quality evidence.

RESULTS: After an extensive review and analysis of the literature, which included systematic reviews and all of the available literature, the evidence for the effectiveness of long-term opioids in reducing pain and improving functional status for 6 months or longer is variable. The evidence for transdermal fentanyl and sustained-release morphine is Level II-2, whereas for oxycodone the level of evidence is II-3, and the evidence for hydrocodone and methadone is Level III. There is also significant evidence of misuse and abuse of opioids. The recommendation is 2A – weak recommendation, high-quality evidence: with benefits closely balanced with risks and burdens; with evidence derived from RCTs without important limitations or overwhelming evidence from observational studies, with the implication that with a weak recommendation, best action may differ depending on circumstances or patients’ or societal values.

CONCLUSION: Opioids are commonly prescribed for chronic non-cancer pain and may be effective for short-term pain relief. However, long-term effectiveness of 6 months or longer is variable with evidence ranging from moderate for transdermal fentanyl and sustained-release morphine with a Level II-2, to limited for oxycodone with a Level II-3, and indeterminate for hydrocodone and methadone with a Level III. These guidelines included the evaluation of the evidence for the use of opioids in the management of chronic non-cancer pain and the recommendations for that management. These guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Because of the changing body of evidence, this document is not intended to be a “standard of care.”

Systematic review of thoracic discography as a diagnostic test for chronic spinal pain.

BACKGROUND: Even though the prevalence of thoracic pain has been reported to be 15% of the general population and up to 22% of the population in interventional pain management settings, the role of thoracic discs as a cause of chronic thoracic and extrathoracic pain has not been well researched. The intervertebral discs, zygapophysial or facet joints, and other structures including the costovertebral and costotransverse joints have been identified as a source of thoracic pain.

OBJECTIVE: To systematically assess the quality of clinical studies evaluating the diagnostic accuracy of provocation thoracic discography.

STUDY DESIGN: A systematic review of provocation thoracic discography.

METHODS: A systematic review of the literature was performed to assess the diagnostic accuracy of thoracic discography with respect to chronic, function limiting, thoracic or extrathoracic pain. Studies meeting the Agency for Healthcare Research and Quality (AHRQ) methodologic quality criteria with scores of 50 or higher were included for the assessment of the level of evidence. Level of evidence was based on the United States Preventive Services Task Force (USPSTF) criteria for the assessment of accuracy of diagnostic studies. Based on the level of evidence, recommendations were made according to Guyatt et al’s criteria.

RESULTS: The clinical value of thoracic provocation discography is limited (Level II-3) with 2C/weak recommendation derived from low quality or very low quality evidence indicating that other alternatives may be equally reasonable.

CONCLUSION: Based on the available evidence for this systematic review, thoracic provocation discography is provided with a weak recommendation for the diagnosis of discogenic pain in the thoracic spine, if conservative management has failed. This is qualified by the need to appropriately evaluate and diagnose other causes of chronic thoracic pain including pain originating from thoracic facet joints.

Systematic review of lumbar discography as a diagnostic test for chronic low back pain.

BACKGROUND: The intervertebral disc has been implicated as an etiology of chronic lumbar spine pain based on clinical, basic science, and epidemiological research. However, there is lack of consensus regarding the diagnosis and treatment of intervertebral disc disorders. Based on controlled evaluations, the lumbar intervertebral discs have been shown to be sources of chronic back pain without disc herniation in 26% to 39%. Lumbar provocation discography, which includes disc stimulation and morphological evaluation, is often used to distinguish a painful disc from other potential sources of pain. Despite the extensive literature, controversy continues about provocation lumbar discography.

STUDY DESIGN: A systematic review of the lumbar provocation discography literature.

OBJECTIVES: To systematically assess the diagnostic accuracy of lumbar discography.

METHODS: A systematic review of the literature was performed to assess the diagnostic accuracy of lumbar discography with respect to chronic low back pain. Study inclusion/exclusion criteria were based on International Association for the Study of Pain (IASP) standards with pain provocation and determination of controlled discs. Selected studies were then subjected to a rating instrument for diagnostic accuracy studies. Specific data were then culled from these studies and tabulated. Quality of evidence was assessed using modified Agency for Healthcare Research and Quality (AHRQ) diagnostic accuracy evaluation. Studies meeting methodologic quality criteria scores of 50 or higher were included in the assessment of the level of evidence. Qualitative analysis was conducted using 5 levels of evidence, ranging from Level I to III, with 3 subcategories in Level II. The rating scheme was modified to evaluate the diagnostic accuracy.

RESULTS: Based on a modified U.S. Preventive Services Task Force (USPSTF) level of evidence criteria, this systematic review indicates the strength of evidence as Level II-2 for the diagnostic accuracy of lumbar provocation discography utilizing IASP criteria.

LIMITATIONS: Limitations include a paucity of literature, poor methodologic quality, and very few studies performed utilizing IASP criteria.

CONCLUSION: Based on the current systematic review, lumbar provocation discography performed according to the IASP criteria with control disc (s) with minimum pain intensity of 7 of 10, or at least 70% reproduction of worst pain (i.e. worst spontaneous pain of 7 = 7 x 70% = 5) may be a useful tool for evaluating chronic lumbar discogenic pain. Discography is an important imaging and pain evaluation tool in identifying a subset of patients with chronic low back pain secondary to intervertebral disc disorders.

Root cause analysis of paraplegia following transforaminal epidural steroid injections: the ‘unsafe’ triangle.

The utilization rate of transforaminal epidural steroid injections (TFESIs), an elective diagnostic and therapeutic spinal procedure, has risen dramatically over the past decade. In 2006 alone, greater than 300,000 thoracolumbar TFESIs were performed on Medicare beneficiaries. Despite the purported superiority of the transforaminal route, compared to other modes of epidural injection, TFESIs are associated with potential hazards. The artery of Adamkiewicz (ARM) might enter any mid thoracic, lower thoracic, or lumbar foramen; the exact level, in a specific patient, will be unknown to the proceduralist. The authors propose that the “safe triangle” approach to transforaminal epidural injections is not safe (TFESIs). Injury to the ARM can lead to paraplegia, independent of operator skill or adjuvant safety initiatives (digital subtraction angiography, local anesthetic test dose). Injury to the ARM is a “black swan” event. The authors believe that catastrophic injury may be averted when performing TFESIs by avoiding the “un-safe,” superoanterior triangle in the foramen and that transforaminal injections should be performed at the inferior aspect of the foramen, known as Kambin’s triangle.

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2–guidance.

RESULTS: Part 2 of the guidelines on responsible opioid prescribing provides the following recommendations for initiating and maintaining chronic opioid therapy of 90 days or longer. 1. A) Comprehensive assessment and documentation is recommended before initiating opioid therapy, including documentation of comprehensive history, general medical condition, psychosocial history, psychiatric status, and substance use history. (Evidence: good) B) Despite limited evidence for reliability and accuracy, screening for opioid use is recommended, as it will identify opioid abusers and reduce opioid abuse. (Evidence: limited) C) Prescription monitoring programs must be implemented, as they provide data on patterns of prescription usage, reduce prescription drug abuse or doctor shopping. (Evidence: good to fair) D) Urine drug testing (UDT) must be implemented from initiation along with subsequent adherence monitoring to decrease prescription drug abuse or illicit drug use when patients are in chronic pain management therapy. (Evidence: good) 2. A) Establish appropriate physical diagnosis and psychological diagnosis if available prior to initiating opioid therapy. (Evidence: good) B) Caution must be exercised in ordering various imaging and other evaluations, interpretation and communication with the patient, to avoid increased fear, activity restriction, requests for increased opioids, and maladaptive behaviors. (Evidence: good) C) Stratify patients into one of the 3 risk categories – low, medium, or high risk. D) A pain management consultation, may assist non-pain physicians, if high-dose opioid therapy is utilized. (Evidence: fair) 3. Essential to establish medical necessity prior to initiation or maintenance of opioid therapy. (Evidence: good) 4. Establish treatment goals of opioid therapy with regard to pain relief and improvement in function. (Evidence: good) 5. A) Long-acting opioids in high doses are recommended only in specific circumstances with severe intractable pain that is not amenable to short-acting or moderate doses of long-acting opioids, as there is no significant difference between long-acting and short-acting opioids for their effectiveness or adverse effects. (Evidence: fair) B) The relative and absolute contraindications to opioid use in chronic non-cancer pain must be evaluated including respiratory instability, acute psychiatric instability, uncontrolled suicide risk, active or history of alcohol or substance abuse, confirmed allergy to opioid agents, coadministration of drugs capable of inducing life-limiting drug interaction, concomitant use of benzodiazepines, active diversion of controlled substances, and concomitant use of heavy doses of central nervous system depressants. (Evidence: fair to limited) 6. A robust agreement which is followed by all parties is essential in initiating and maintaining opioid therapy as such agreements reduce overuse, misuse, abuse, and diversion. (Evidence: fair) 7. A) Once medical necessity is established, opioid therapy may be initiated with low doses and short-acting drugs with appropriate monitoring to provide effective relief and avoid side effects. (Evidence: fair for short-term effectiveness, limited for long-term effectiveness) B) Up to 40 mg of morphine equivalent is considered as low dose, 41 to 90 mg of morphine equivalent as a moderate dose, and greater than 91 mg of morphine equivalence as high dose. (Evidence: fair) C) In reference to long-acting opioids, titration must be carried out with caution and overdose and misuse must be avoided. (Evidence: good) 8. A) Methadone is recommended for use in late stages after failure of other opioid therapy and only by clinicians with specific training in the risks and uses. (Evidence: limited) B) Monitoring recommendation for methadone prescription is that an electrocardiogram should be obtained prior to initiation, at 30 days and yearly thereafter. (Evidence: fair) 9. In order to reduce prescription drug abuse and doctor shopping, adherence monitoring by UDT and PMDPs provide evidence that is essential to the identification of those patients who are non-compliant or abusing prescription drugs or illicit drugs. (Evidence: fair) 10. Constipation must be closely monitored and a bowel regimen be initiated as soon as deemed necessary. (Evidence: good) 11. Chronic opioid therapy may be continued, with continuous adherence monitoring, in well-selected populations, in conjunction with or after failure of other modalities of treatments with improvement in physical and functional status and minimal adverse effects. (Evidence: fair).

DISCLAIMER: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a “standard of care.”

American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part I–evidence assessment.

BACKGROUND: Opioid abuse has continued to increase at an alarming rate since the 1990 s. As documented by different medical specialties, medical boards, advocacy groups, and the Drug Enforcement Administration, available evidence suggests a wide variance in chronic opioid therapy of 90 days or longer in chronic non-cancer pain. Part 1 describes evidence assessment.

OBJECTIVES: The objectives of opioid guidelines as issued by the American Society of Interventional Pain Physicians (ASIPP) are to provide guidance for the use of opioids for the treatment of chronic non-cancer pain, to produce consistency in the application of an opioid philosophy among the many diverse groups involved, to improve the treatment of chronic non-cancer pain, and to reduce the incidence of abuse and drug diversion. The focus of these guidelines is to curtail the abuse of opioids without jeopardizing non-cancer pain management with opioids.

RESULTS: 1) There is good evidence that non-medical use of opioids is extensive; one-third of chronic pain patients may not use prescribed opioids as prescribed or may abuse them, and illicit drug use is significantly higher in these patients. 2) There is good evidence that opioid prescriptions are increasing rapidly, as the majority of prescriptions are from non-pain physicians, many patients are on long-acting opioids, and many patients are provided with combinations of long-acting and short-acting opioids. 3) There is good evidence that the increased supply of opioids, use of high dose opioids, doctor shoppers, and patients with multiple comorbid factors contribute to the majority of the fatalities. 4) There is fair evidence that long-acting opioids and a combination of long-acting and short-acting opioids contribute to increasing fatalities and that even low-doses of 40 mg or 50 mg of daily morphine equivalent doses may be responsible for emergency room admissions with overdoses and deaths. 5) There is good evidence that approximately 60% of fatalities originate from opioids prescribed within the guidelines, with approximately 40% of fatalities occurring in 10% of drug abusers. 6) The short-term effectiveness of opioids is fair, whereas the long-term effectiveness of opioids is limited due to a lack of long-term (> 3 months) high quality studies, with fair evidence with no significant difference between long-acting and short-acting opioids. 7) Among the individual drugs, most opioids have fair evidence for short-term and limited evidence for long-term due to a lack of quality studies. 8) The evidence for the effectiveness and safety of chronic opioid therapy in the elderly for chronic non-cancer pain is fair for short-term and limited for long-term due to lack of high quality studies; limited in children and adolescents and patients with comorbid psychological disorders due to lack of quality studies; and the evidence is poor in pregnant women. 9) There is limited evidence for reliability and accuracy of screening tests for opioid abuse due to lack of high quality studies. 10) There is fair evidence to support the identification of patients who are non-compliant or abusing prescription drugs or illicit drugs through urine drug testing and prescription drug monitoring programs, both of which can reduce prescription drug abuse or doctor shopping.

DISCLAIMER: The guidelines are based on the best available evidence and do not constitute inflexible treatment recommendations. Due to the changing body of evidence, this document is not intended to be a “standard of care.”