By Olga Maystruk, Designer and Brand Strategist, and
Tamara Vasquez, Risk Management Representative
Presentation
On April 14, a 50-year-old man with a long history of chronic pain, spinal injuries and procedures, depression, and obesity, came to see Anesthesiologist A for pain management. The patient sought treatment for radiating neck and low back pain and migraine headaches. The patient’s medications included methadone, ibuprofen, paroxetine, tizanidine, and hydrocodone/acetaminophen (7.5/325).
An MRI of the patient’s lumbar spine revealed degenerative disc disease at the L3-4 and L4-5 vertebrae with spinal stenosis at L4-5. A cervical spine MRI showed a C4-5 fusion but was otherwise normal.
Physician action
On April 22, Anesthesiologist A performed a bilateral L4-5 epidural steroid injection (ESI). The patient did not return for a follow-up appointment one month later.
However, the patient did return to the physician’s office on July 1. He reported mild pain relief for approximately ten days following the ESI. The patient’s motor strength was normal, 5/5 throughout.
Three weeks later during the next follow-up appointment, Anesthesiologist A and the patient discussed an epiduroscopy and Percutaneous Ablation and Curettage and Inferior Foraminotomy (PACIF) with a plan to refer to neurosurgery if the patient saw no relief. The patient agreed to the procedures.
On August 16, the patient was admitted for the epiduroscopy and PACIF at L5 on the right side. During the procedure, Anesthesiologist A encountered epidural space adhesions and could not obtain access to the neural foramen of L4-5 on the right. Due to minor but persistent bleeding, Anesthesiologist A decided to terminate the procedure and injected 5 ml of a hemostatic matrix in the area of bleeding and retracted the scope.
A neurosurgery consultation was obtained. Neurosurgeon A noted no neurological deficits on examination and indicated no need for neurosurgical intervention.
Anesthesiologist A saw the patient the next day and noted weakness of the right leg. An MRI showed postoperative changes at L4-5 with an epidural collection resulting in mild stenosis starting at L4-5 and extending to S2, consistent with evolving traumatic epidural hemorrhage. The patient was discharged to home.
On August 21 during a follow-up telephone call, the patient reported inability to raise his big toe and foot on the right side. Anesthesiologist A referred the patient to Neurosurgeon B.
Neurosurgeon B performed electromyography and nerve conduction velocity tests on August 26. The patient had significant pain and weakness and expressed concern for injury in the past 10 days.
The next day, the patient underwent decompression and laminectomy of L4-5 and L5-S1 with removal of the hemostatic matrix and an epidural hematoma. The patient was discharged the next day with an ankle foot orthotic.
Following physical therapy, the patient’s foot drop resolved; however, there may be elements of secondary gain in the future.
Allegations
The patient filed a lawsuit against the anesthesiologist alleging:
- performing a non-medically indicated and experimental procedure;
- improper performance of the procedure; and
- failure to obtain timely neurosurgical consultation.
Legal implications
While acknowledging common complications during surgery such as bleeding, experts for the defense expressed concern about the follow-up care. Additionally, one consultant was critical of the PACIF procedure itself due to it still being under development at the time. In this expert’s opinion, the choice of the procedure and injection of a hemostatic matrix made the treatment in this case fall below the standard of care.
Expert consultants for the defense did not note any issues with the timing of the neurosurgical consultation.
Disposition
The case was settled on behalf of the anesthesiologist.
Risk management considerations
It is the duty of the physician performing a procedure to obtain informed consent from the patient. The discussion should include the patient’s condition, procedure being performed, risks and potential complications of the procedure, benefits, and alternatives. There should be adequate time in the discussion for the patient to ask questions, and the physician should respond to all questions as accurately as possible.
Others may help with administering informed consent documents, witnessing the patient’s signing, and reinforcing instructions; however, it is the treating physician’s responsibility to explain the procedure(s), ensure that all questions and concerns are addressed, and the patient’s understanding and willingness to proceed is documented. The process of obtaining informed consent should be documented in both the office visit note and at the facility where the procedure is performed. In this case, the informed consent discussion was not recorded in the patient's medical record.
A defense consultant questioned the use of ibuprofen which was on the patient’s medication list three days before surgery. It was noted that ibuprofen should have been stopped seven days before the procedure as it is a platelet inhibitor and increases the risk of bleeding. The American Society of Regional Anesthesia (ASRA) recommends that discontinuation of ibuprofen before a procedure occur for a duration equal to at least five half-lives of the drug.1
The same defense consultant stated that the patient underwent an unnecessary invasive procedure and the use of a hemostatic matrix deviated from reasonable treatment. When applicable, reasons for any variation from routine procedures should be thoroughly documented in the patient record.
Lastly, there were issues with limited follow up and monitoring of the patient. Five days after the procedure, the patient called with right foot weakness, but the patient was not re-evaluated by neurosurgery until six days later. Records reviewed did not include documentation of follow-up appointments or care.
For continuity of care, clearly communicate to the patient your follow-up plan and expectations, then document when follow-up care and appointments are accomplished. Document this communication in the record, along with participants in the discussion, dates, locations, and times. In this case it may have warranted a communication between the treating physicians to expedite follow-up care with neurosurgery rather than having the patient wait an additional six days.
Source
1. McCormick Z, Popescu A, Smith C. Risk of Bleeding with Non-Aspirin Non-Steroidal Anti-Inflammatory Drugs Before Spine Procedures. Spine Intervention Society Factfinders for Patient Safety. Spine Intervention Society. March 2018. Available at https://cdn.ymaws.com/www.spineintervention.org/resource/resmgr/factfinder/factfinder_2018_03_nsaid.pdf. Accessed March 24, 2022.
Olga Maystruk can be reached at olga-maystruk@tmlt.org.
Tamara Vasquez can be reached at tamara-vasquez@tmlt.org.
