The objective of this article was to present a systematic review of the safety issues encountered in interventional pain management. Patient safety is an important consideration in the practice of interventional pain management. Although there is a paucity of scientific articles addressing this topic, the authors have reviewed the literature and present a review of the topic, as well as strategies to minimize the risk to patients undergoing interventional spine procedures.
Scope of errors in interventional pain management
Human Error
To err is human and as long as humans interact in providing care, there is the potential for human error. Human error can be classified into knowledge-based error, rule-based error, and skill-based error. Skill-based errors are a result of lack of judgment (eg, a physician who unintentionally orders 10 mg of dilaudid, instead of 1.0 mg of dilaudid), rule-based errors are a result of ignorance of rules related to a situation (eg, a physician who performs a cervical epidural injection instead of a lumbar epidural injection failing to do a time out to verify the type of procedure before starting the procedure), and knowledge-based errors are a result of incomplete or incorrect knowledge in a particular problem or situation (eg, a novice interventionalist who unknowingly heats up the annuloplasty canula in the spinal canal instead of the disc, while performing an intradiscal annuloplasty).
Regardless of the type of error, medical errors in pain management can be catastrophic (ie, spinal cord injury after spinal injections or respiratory arrest after opiate overdose). Regrettably, in the practice of interventional pain management, a significant number of patients are victims of avoidable human error. In a closed claims study, Fitzgibbon and colleagues found 97% of the closed claims in pain management malpractice suits in pain management were related to invasive procedures. Of the invasive procedures, most of the complications were related to epidural steroid injections. Unfortunately, the patient who was a victim of error before the injury can also be prone again to medical errors in the hands of the pain management physician.
Technical Problems
Advances in the field of pain management have introduced several types of devices into clinical practice. These include (1) the fluoroscope and the fluoroscope table, (2) radiofrequency generator, (3) dorsal column stimulator, and (4) intrathecal drug delivery systems. The machines are not perfect; they break down, at times even during the procedure. For example, a recently inspected fluoroscope might fail during a procedure, requiring replacement in the middle of the procedure. This can create a safety hazard for the patient. The interventional pain management physician should be able to recognize when equipment is malfunctioning and implement procedures to remedy the situation in the event of a breakdown, without compromising patient safety.
Communication Problems
Interventional pain management requires teamwork, even for the solo practitioner. Pain management physicians work within a team that can also include pain management nurses, anesthesiologists, nurse anesthetists, radiology technicians, operating room technicians, physical therapists, occupational therapists, secretaries, pharmacists, and, most importantly, the patient. Effective communication is a key element in the successful completion of interventional pain procedures. Lack of communication or miscommunication among team members can contribute to patient safety errors. Within the team, errors can occur when one team member is not able to perform his or her role adequately, thereby jeopardizing the patient’s safety. For instance, a novice radiology technician who is not experienced with the use of the fluoroscope can produce poor radiological images that result in poor visualization of critical areas of the spine. There should be a good understanding of the terminology used in the procedure by all the team members (ie, “10° cephalad tilt” or “30° right oblique tilt”). Poor communication among the team members during the procedure can result in poor visualization of critical spinal anatomy during a spinal procedure. In another instance, lack of communication between the physician and the radiology technician can lead to a potentially catastrophic injury when the technician elevates the table on which the patient is lying to very close to the image intensifier, resulting in an instant spinal cord injury if the needle is still in the neck of the patient.
Regardless of years of clinical expertise, an interventional pain management physician can potentially make a “wrong patient/wrong side/wrong procedure” error while performing an interventional pain procedure secondary to improper communication at the team level. It is important to understand that errors happen at the most prestigious hospitals in the most experienced hands.
Characteristics of Patients with Pain Syndromes That Place Them at Increased Safety Risk During Interventional Pain Management Procedures
Elderly patients with pain syndromes can have comorbid diseases that require the use of anticoagulants. The use of anticoagulants just before the interventional pain management procedure can increase the risk for epidural hematomas with spinal injections.
Types of medical errors commonly seen in pain management
Diagnosis-Related Errors
Diagnosis-related errors are typically the result of a medical condition that was misdiagnosed or not diagnosed in a timely manner. Some examples are described in the following sections.
Neurogenic claudication versus vascular claudication
Performing an epidural steroid injection on a patient with misdiagnosed vascular claudication can occur as a result of not performing an adequate vascular assessment as part of the history and physical examination. Vascular claudication and neurogenic claudication have similarities and differences and clearly excluding a vascular claudication is necessary before performing an epidural steroid injection for neurogenic claudication.
Cervical radiculopathy versus primary shoulder pathology
Regional joint pathology can manifest as neck pain with radiation to the ipsilateral shoulder and misdiagnosis can result in unnecessary injection to the cervical spine.
Gluteal pain syndromes
Regional hip pathology can manifest as low back pain with radiation to the ipsilateral hip and misdiagnosis can result in unnecessary injection to the lumbar spine. Misdiagnosis of Piriformis syndrome and assuming a diagnosis of lumbar radiculopathy can result in an unnecessary injection.
Headaches
Misdiagnosis of migraine versus intracranial lesions can result in an unnecessary injection. Although the vast majority of patients with headaches do not have tumor, headaches can occur in 50% of patients with intracranial tumors. Awareness of potential tumors as a cause of headaches is necessary to prevent a misdiagnosis. Neurologic evaluation can provide clues to mass lesion, such as seizures, focal findings, mass effect, and personality changes.
Low back pain: malignancy versus lumbar spine degenerative joint disease
Elderly patients often present with low back pain secondary to osteoarthritis, from which they can benefit from epidural steroid injections. However, osteoporotic compression fractures or underlying metastatic disease are also part of the differential diagnosis and if present would require different treatments and prompt attention.
Treatment-Related Errors
There are several different types of treatment-related errors and some examples are described in the following sections.
Direct spinal cord injury
Patient sedation during an interventional procedure is helpful, as this can minimize patient anxiety and patient movement during the procedure, and allow efficient needle placement. Patient sedation, although useful, needs careful attention during cervical and thoracic epidural steroid injections. When relying solely on loss of resistance technique, one can run the risk of the Touhy needle advancing farther anteriorly, as the ligamentum flavum can be incomplete in some patients. Deep sedation during epidural steroid injection is risky if the needle inadvertently enters the spinal cord, and medication is injected into the spinal cord. Ideally, one has to be able to talk to the patient during cervical and thoracic epidurals to avoid the potential risk of direct injury to the spinal cord. Similarly, when performing a cervical epidural steroid injection, deep sedation is risky and has to be avoided. In instances when the patient goes into deep sedation, one has to wait until the patient is more awake until doing procedures, such as cervical and thoracic epidural steroid injections, where valuable feedback from the patient can prevent potential neurologic complications.
The risk of direct cord injury is increased when the injection is performed at the same level as there is severe central stenosis. For instance, if a patient has a severe stenosis at C5-6 level, one should not perform a spinal injection at this level, as the risk of spinal cord injury is high because of narrow epidural space at that level. The injection can be performed at one level below. Baseline neurologic examination is also necessary in case the patient has changes in neurologic status while in the recovery room. A patient can also have a preexisting myelopathy, and physical examination should check for this possibility. The interventional pain management physician should review magnetic resonance imaging films, even though the films may have already been interpreted by a radiologist.
Direct nerve injury
A patient can have a nerve root injury typically after a transforaminal epidural steroid injection and very rarely after an interlaminar injection if the needle strays laterally into the intervertebral foramen. Sedation has to be minimal to get a response from the patient if the nerve root is accidently injured.
Spinal cord infarctions can occur with transforaminal epidural steroid injections. The risk is higher with cervical transforaminal epidural steroid injections, although there is a risk with upper lumbar transforaminal epidural steroid injections as well. These risks can be avoided using a live fluoroscope with digital subtraction techniques to identify vascular uptake. Negative aspiration is not a reliable test to identify if the needle is in a radicular artery. The safe triangle radiologic landmark (the triangle is composed of a roof made up of the pedicle, a tangential base corresponding to the exiting nerve root, and the lateral border of the vertebral body) was used for transforaminal epidural steroid injections for decades. Studies have shown that the “safe triangle” is no longer safe because of potential risks of embolization of the anterior spinal artery; hence, it is safer to inject in the inferior portion of the intervertebral foramen in thoracic and upper lumbar levels.
Dural punctures after epidural steroid injections
Patients can have spinal fluid leaks after epidural access for steroid injections or epidural lead placement. This can be a problem with use of large-gauge Touhy needle in epidural lead placement where a 14-gauge needle is used instead of a 20-gauge needle in routine epidural steroid injection use. Post spinal headaches may require fluid hydration, caffeine, nonsteroidal anti-inflammatory drugs, and blood patch if pain is not controlled. Using the Touhy needle with the bevel parallel to the length of the spinal column can split, rather than cut, the dural fibers, potentially reducing the incidence of cerebrospinal fluid leaks.
Epidural hematomas after epidural steroid injections
Epidural hematomas can occur after a translaminar epidural injection for steroid administration or epidural lead placement. Anticoagulants need to be stopped before the procedure.
Pneumothorax following trigger point injections
Pneumothorax can occur while performing trigger point injections in the posterior thoracic wall. Use of a fluoroscope can visualize the ribs and the intercostal space to minimize the risk of pneumothorax.
Infections after spinal injections
Epidural abscess, meningitis, discitis, or osteomyelitis is a potential problem with any spinal injection if performed when the sterile barrier is breached. Although most spinal injections do not need antibiotics, they are necessary before advanced procedures, such as discography, intradiscal annuloplasty, nucleoplasty, spinal cord stimulation, and intrathecal opiate trial and pump placement. Although cefazolin is the most common antibiotic used, in patients with an allergy to cefazolin, clindamycin is an alternative. The skin is a potential source for staphylococcal infection and hence it needs to be cleansed with iodine-based dyes. In patients who have allergies to iodine, absolute alcohol can be used instead. Meningitis has been linked to contaminated compounded betamethasone from local pharmacies Sterile drapes are necessary for invasive procedures, such as discography and spinal cord stimulators. Urinary tract infections or respiratory infections are contraindications for spinal injections because of the risk of seeding the bacteria into the site of injection. Skin infections at the site of injections are also a contraindication.
Falls
Patients who are sedated can potentially fall off the narrow table during or after a procedure. Patients who receive sedation need to be positioned on a stretcher or in a recliner and should not be allowed to stand, especially when the spinal injection is done in an office setting. There is also a risk for falls if the fluoroscopy table is not powered on, especially during transfer of a patient from a stretcher to a fluoroscopy table. The ideal table for a spinal procedure is a diving board table with the least amount of hardware possible, especially during a transforaminal approach. Tables that can be placed in a jackknife position are useful when using an interlaminar approach for epidural steroid injections or dorsal column lead placement.
Radiofrequency equipment
The Food and Drug Administration received 628 reports of grounding pad burns between December 1996 and April 1998 from various surgical procedures using grounding pads. In the pain management field, grounding pad injury can potentially occur with improper grounding in several scenarios, such as facet radiofrequency nerve ablation procedures, intradiscal annuloplasty procedures, and use of cautery during a spinal cord stimulator placement.
Radiation safety
In women of childbearing age, urine pregnancy tests are mandatory to avoid fetal radiation exposure. In younger individuals, lead shielding of the table is essential to avoid radiation exposure to the gonads. The shield has to be placed before the patient gets on the table, as the radiation passes from the inferior portion of the table superiorly. One has no control on the lateral-view radiation exposure. Linear collimation and spherical collimation can avoid radiation exposure. Use of pulse mode (8 pps) can drastically reduce fluoroscopic exposure.
Interventional medication toxicity
Steroids
Patients receiving steroids as part of the interventional procedure have an increased risk of having elevated blood sugar levels and elevated blood pressure. Steroids have also been linked to vaginal bleeding in women. Appropriate consultation is necessary if the symptoms persist.
Intrathecal morphine trials
Patients undergoing an intrathecal morphine trial should have an overnight intensive care unit admission for monitoring of vital signs because of the concern for hypotension. Patients might also require urinary catheterization because of urinary retention.
Local anesthetics
Local anesthetics can cause cardiac arrhythmias, especially during a sympathetic block, because of the close proximity to the vascular structures. Cardiac monitoring is necessary before, during, and after the procedure.
Allergy
Iodine/iodine contrast/noniodine contrast
Patients can have an allergy to contrast. Noniodinated contrast is a useful alternative.
Steroid
Patients can have allergy to ingredients in the steroid mixture. If the patient has a history of allergies to these ingredients, he or she would need to undergo skin testing to determine the preparation of steroid that is causing allergy.
Latex
Latex allergy is a concern and, if needed, nonlatex gloves should be used. In addition, latex vial tops would also need to be removed so that the needle does not penetrate through the rubber stopper.
Patient identifiers
Wrong patient
Wrist bands can be wrongly printed or wrongly attached and one has to verify the name and data on the wrist band before anesthesia.
Wrong side
Patients scheduled to receive selective epidurals should have the skin marked on the appropriate side.
Wrong procedure
Patients often have cervical and lumbar pathologies, and a patient may have a worsening of the cervical pathology on the day a procedure of the lumbar region is scheduled to be performed. It is important to confirm with the patient the type and location of the procedure for the date that it is being performed.
Anesthesia complications
To minimize complications associated with anesthesia, it is recommended that perioperative monitoring occur. The monitoring should include pulse oximetry, blood pressure, temperature, and cardiac telemetry A fully stocked emergency crash cart should be nearby. Peripheral intravenous (IV) access is also recommended. Vasovagal reactions can occur after procedures, and, hence, IV access obtained before the procedure can be used to treat the effects of this type of reaction. Most pain management procedures are performed in prone position, which can increase risk for hypoventilation. Monitoring for this problem is also recommended. Most medications are metabolized via the kidneys and dose adjustment is necessary when using anesthetics.
Aspiration pneumonia
Patients should be advised to fast after midnight before the procedure because of the risk of aspiration pneumonia.
Postprocedure monitoring
Patients need to be monitored before discharge with the length of time depending on the type of anesthesia used (ie, local vs sedation). Patients who received a stellate ganglion block should have their swallowing function monitored. Discharge criteria postprocedure include that the patient should be alert, awake, and able to ambulate as per expectations of the anesthesia. Patients with chronic obstructive pulmonary disease are at risk from an anesthesia standpoint, especially postoperatively, and require close monitoring. Cellulitis can occur at site where peripheral IV access was obtained.
Communication-related issues
Communication among rehabilitation staff, among consultants, and with the family and patient are all critical. Patient expectations of risks, benefits, and alternatives have to be clearly explained to avoid frustration with negative outcomes from pain management procedures.
Organization-related issues: location of the procedure
Hospital-based procedures (versus office and ambulatory procedures) have the added benefit of having medical and surgical specialists and intensive care units available in the event of a postprocedure complication.
Competency of Staff in Providing Care to the Patients
Most hospitals require proof of training in pain management for interventional procedures, either via fellowship training or under mentorship. Most pain management physicians undergo a year of accredited fellowship training, and are certified by the American Board of Medical Specialties. In addition, most hospitals credentialing for pain management require recertification in infection control, radiation safety training, sedation safety training, and basic and advanced life support. Physicians who attend weekend courses for pain management do perform procedures. The American Society of interventional Pain Management is concerned about the risk to patient safety and the real potential for patients experiencing less than optimal clinical outcomes when they are treated by providers who have not successfully completed rigorous specialty medical training. It is important that physicians performing interventional procedures have the proper training and experience to perform them, as well as update their skills and knowledge base on a regular basis. Staff working with the physician should also have the proper training and experience.
Related posts:
Patient Safety and Quality Improvement in Rehabilitation Medicine
Medication Safety in Rehabilitation Medicine
Patient Safety Considerations in the Rehabilitation of the Individual with Cognitive Impairment
Patient Safety in Rehabilitation Medicine: Traumatic Brain Injury
Patient Safety in the Rehabilitation of the Adult with an Amputation
Safety Considerations During Cardiac and Pulmonary Rehabilitation Program
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