by Rachel Pollock, Marketing and Brand Strategist, and
Tamara Vasquez, Risk Management Representative
Presentation
On December 2, a 45-year-old man came to see Pain Management (PM) Physician A for treatment of neck, back, and shoulder pain resulting from a car accident on October 15. The patient previously consulted a chiropractor and noted some mild improvement with treatment.
Physician action
PM Physician A documented that the patient presented with non-radicular neck pain that had gradually improved with chiropractic treatment. He scheduled a cervical MRI and prescribed tizanidine and naproxen.
A week later, the patient returned and reported persistent neck pain as well as shoulder pain, numbness, and tingling when rotating his neck to the right. The patient believed that the prescribed medications were not effective and requested to explore less conservative pain management options. PM Physician A recommended a transforaminal epidural steroid injection (ESI).
On December 21, PM Physician A performed a right C3-4 and C5 transforaminal injections with fluoroscopic guidance on the patient. The procedure was administered under anesthesia and no adverse effects were documented. At a follow-up appointment, the patient was noted as having responded well to the injections with relief in his upper right arm and improved functionality. Physical therapy was also prescribed.
On February 3, the patient returned and reported that his pain had returned to pre-procedure levels and that physical therapy was not effective.
On February 16, PM Physician A performed a second set of injections, right C3-4 and C5-6 transforaminal ESIs, on the patient. According to the patient schedule, PM Physician A performed 16 procedures that day with this patient’s injections being the final procedure of the day.
During the procedure, Anesthesiologist A administered total intravenous anesthesia (TIVA) to the patient beginning at 11:29 a.m. and concluding at 11:45 a.m. The ESIs started at 11:37 a.m. and were completed by 11:43 a.m. PM Physician A reported no unusual events during the injections and that the patient tolerated the procedure well.
At 11:47 a.m., while transferring the patient to a gurney, the patient was found to be cyanotic. Anesthesiologist A called a code and resuscitative measures were performed. The patient was transferred to the hospital, where he was diagnosed with anoxic brain damage and severe disability.
Allegations
A lawsuit was filed against the PM Physician A and Anesthesiologist A for failure to adequately and safely perform an ESI.
Legal considerations
ESIs have inherent risks and potential complications including infection, nerve damage, stroke, brain damage, and death.
Consultants for the defense were critical of the PM physician’s decision to perform the C3-4 transforaminal ESI, as there was no documentation of radicular pain and it was not well supported by the patient’s history, examination, or MRI findings.
Plaintiff experts were critical of PM Physician A’s technique and execution of the procedure. Specifically, they stated there was a lack of care and precision with positioning the needle and improper use of contrast and digital subtraction imaging. One expert stated that PM Physician A placed the needle lateral to the normally targeted anatomy for this injection. He claimed the fluoroscopic imaging showed the contrast was injected into a vascular structure rather than the intervertebral foramina.
Another expert reviewing the case felt that, while PM Physician A was within the standard of care to have recommended the ESIs, his use of a posterior approach while the patient was prone would make it “virtually impossible to get the needle into the intervertebral foramen, as it angles forward, ventrally.” He believed that PM Physician A did not know the position of the needle and injected into the subarachnoid space of the cord leading to “a high spinal anesthesia, which interfered with the breathing center and caused accompanying vasodilation and circulatory collapse.”
The level of anesthesia was also a concern. Consultants for both the defense and the plaintiff stated that had the patient been able to respond to stimuli or communicate adverse sensations, the injections may have been stopped and the catastrophic outcome avoided.
One plaintiff’s expert believed PM Physician A breached the standard of care by requesting a deep sedation for the ESIs. Defense experts noted that even if the PM physician inadvertently injected intravascularly, the anesthesiologist could have more closely monitored the patient.
Disposition
The case was settled on behalf of PM Physician A and Anesthesiologist A.
Risk management considerations
A cervical epidural injection may be indicated when there are radicular pain symptoms, including numbness, tingling, or a burning type of pain. 1 According to some defense consultants, PM Physician A’s decision to perform the C3-4 transforaminal ESI was not the appropriate course of action based on the patient’s symptoms. When applicable, reasons for electing not to use non-routine treatment should be thoroughly documented.
Anesthesiologist A used total intravenous anesthesia (TIVA), and the patient received a combination of propofol, ketamine, fentanyl, and lidocaine.
When administering these drugs, the physician should consider each patient’s individual needs and dosing capacity. During a procedure when anesthesia is used, close observation of the patient’s response is required.
Both defense and plaintiff experts stated that the administration of TIVA was the wrong choice in this case. Had the patient been able to respond to stimuli and communicate adverse sensations, the outcome in this case may have been different.
Guidelines from the American Society of Anesthesiologists (ASA) — updated since the time of this case — state that interventional pain procedures generally only require local anesthesia. “When sedation is provided during the performance of a pain procedure, it should allow the patient to be responsive during critical portions of the procedure, e.g., to report potential procedure-related paresthesia, acute changes in pain intensity or function, or potential toxicities.” 2
The ASA has identified several procedures that do not require moderate sedation. ESIs are included on this list. 2
However, the ASA acknowledges that “significant patient anxiety and/or medical comorbidities may be an indication for moderate (conscious) sedation or anesthesia care team services. In addition, procedures that require the patient to remain motionless for a prolonged period of time and/or remain in a painful position may require moderate sedation or anesthesia care team services.” 2 Each case and patient must be evaluated individually to determine the best course of treatment.
When administering office-based anesthesia, ensure you check with the ASA and your state medical board for the most current rules and guidance.
Sources
1 Cervical Epidural Steroid Injections. Cleveland Clinic. Last reviewed January 25, 2022. Available at https://my.clevelandclinic.org/health/treatments/22293-cervical-epidural-steroid-injection. Accessed March 27, 2023.
2 American Society of Anesthesiologists. Statement on Anesthetic Care During Interventional Pain Procedures for Adults. Last amended October 13, 2021. Available at https://www.asahq.org/standards-and-guidelines/statement-on-anesthetic-care-during-interventional-pain-procedures-for-adults. Accessed March 27, 2023.
Rachel Pollock can be reached at rachel-pollock@tmlt.org.
Tamara Vasquez can be reached at tamara-vasquez@tmlt.org.
