Adverse events associated with fluoroscopically guided lumbosacral transforaminal epidural steroid injections.

BACKGROUND CONTEXT: Although the types and incidence of adverse events (AEs) associated with transforaminal epidural steroid injection (TFESI) have been described, no study has used a systematic standardized questionnaire to solicit AEs from patients to capture an accurate range and incidence of complications. PURPOSE: The aim was to systematically identify the types and incidence of AEs associated with TFESI. Additionally, this study evaluated demographic and clinical factors that may predict a higher risk of an AE. STUDY DESIGN/SETTING: This was a retrospective cohort study from a multiphysician academic PM&R clinic. PATIENT SAMPLE: Patients, aged 19 to 89, who underwent a fluoroscopically guided TFESI for lumbosacral radicular pain between 2004 and 2007 were included. OUTCOME MEASURES: The relationship of AEs with gender, age, trainee presence, steroid type, preprocedure visual analog scale (VAS) pain score, systolic blood pressure, fluoroscopy time, and corticosteroid injectate volume was analyzed. METHODS: Adverse event data were collected using a survey both immediately and at 24 to 72 hours after TFESI. Statistical analysis was performed using the chi-square, Fisher exact, or Wilcoxon rank sum two-sided tests. Logistic regression analysis was also performed. C.P. is the owner of Rehabilitation Institute of Chicago Physiatric Log & Analysis System computer software. RESULTS: In 1,295 consecutive patients undergoing 2,025 TFESI procedures, immediate AEs and delayed AEs occurred after 182 (9.2%) and 305 (20.0%) injections, respectively. The most common immediate AEs were: vasovagal reaction (4.2%) and interrupted procedure from intravascular flow (1.7%). Common delayed AEs included: pain exacerbation (5.0%), injection site soreness (3.9%), headache (3.9%), facial flushing/sweating (1.8%), and insomnia (1.6%). Significant associations were identified between AEs and gender, age, preprocedure VAS, steroid type, and fluoroscopy time. Trainee involvement in the procedure did not impact the complication rate. CONCLUSIONS: Fluoroscopically guided lumbosacral TFESI is associated with a similar rate of minor AEs both immediately and 24 to 72 hours after procedure that are typical of other axial corticosteroid injections. Permanent AEs were not found in this sample. The most common AEs associated with TFESI include vasovagal episodes, procedure interruption from intravascular flow, pain exacerbation, injection site soreness, headache, and insomnia.

Adverse events associated with fluoroscopically guided zygapophyseal joint injections.

BACKGROUND: In spite of the widespread performance of intra-articular zygapophyseal joint (IAZJ) injections, we know of no systematic analysis to date that examines the risks and types of adverse events when IAZJ injections are performed. OBJECTIVE: To describe the type, incidence, and factors contributing to adverse events associated with fluoroscopically guided IAZJ injections. STUDY DESIGN: A retrospective, cohort study of English-speaking adults aged 18 - 90 years who underwent fluoroscopically guided IAZJ injections between March 8, 2004, and April 19, 2007. Following IAZJ injections, 3 senior researchers recorded the presence and type of adverse events. The relationship of adverse events with age, gender, fluoroscopy time, vital signs, and trainee presence was analyzed with Fisher's exact or Wilcoxon rank sum 2-sided tests. Frequency of immediate (during or immediately after the procedure) or delayed (within 24 - 72 hours following the procedure) adverse events. SETTING: Tertiary, academic, outpatient physical medicine and rehabilitation interventional spine clinic. RESULTS: One hundred ninety-one patients (111 men) underwent 239 procedures. The mean and standard deviation (SD) of subject age was 56.4 (16.6) years ranging from 20 to 89. The mean and SD of pre-procedure 11-point Visual Analog Pain Scale was 5.5 (2.2) ranging from 0 to 10, and for post-procedure was 2.6 (2.6) ranging from 0 to 10. Trainees were involved in 52.3% of procedures. Reported immediate adverse events were vasovagal reaction (3.8%, n = 9) and steroid clogged needle (0.4%, n = 1). Follow-up data were available for 185/239 procedures (77.4%). There were 35 adverse events reported at mean follow-up interval of 1.8 days, of which the most frequent were injection site soreness (6.0%, n = 11), pain exacerbation (4.3%, n = 8), sleeplessness (2.2%, n = 4), and transient headache (1.6%, n = 3). Patient gender, age, trainee involvement, pre-procedural pain score, systolic or diastolic blood pressure, pulse, hemoglobin saturation as measured by pulse oximetry, volume of corticosteroid injected, and duration of fluoroscopy were not found to have a significant effect on immediate or delayed adverse events. LIMITATIONS: This study is limited by a 24- to 72-hour follow-up window, which may have also been too small to capture more delayed complications, and a sample size too small to accurately define the incidence of rare complications. CONCLUSION: Fluoroscopically guided IAZJ injections have minimal adverse effects. The most common immediate adverse event was vasovagal reaction and most common delayed adverse event was injection site soreness.

Fluoroscopy procedure and equipment changes to reduce staff radiation exposure in the interventional spine suite.

BACKGROUND: Fluoroscopic guided percutaneous interventional spine procedures are increasingly performed in recent years as they have been shown to be target specific and enhance patient safety. However, ionizing radiation has been associated with stochastic effects such as cancer and genetic defects as well as deterministic effects such as cataracts, erythema, epilation, and even death. These are dose related, and hence, measures should be taken to minimize radiation exposure to patients and health care personnel to reduce these adverse effects. OBJECTIVE: A risk reduction project was completed with the goal of reducing effective doses to the staff and patients in a university-based spinal interventional practice. Effective dose reduction to the staff and patients was hypothesized to occur with technique and equipment changes in the procedure suite. The goal of this study was to quantify effective dose rates to staff before and after interventions. STUDY DESIGN: Retrospective study comparing descriptive data of effective dose to the health care staff before and after implementation of a combination of technique and equipment changes. METHODS: Technique changes from pre to post intervention period included continuous needle advancement under continuous fluoroscopic controlled by the interventional physician to intermittent needle advancement under pulsed fluoroscopic controlled by the radiology technician. Equipment changes included circumferential lead drape skirt around the procedure table and use of mobile transparent lead barriers on both sides of the procedure table.Effective dose exposure measured in Millirem (mrem) from the radiation dosimetry badges for pre-intervention (February 2009 through June 2009) and post-intervention (November 2009 through March 2010) periods were examined through monthly radiation dosimetry reports for the fluoroscopy suite staff. RESULTS: A total of 685 interventional procedures were performed in the pre-intervention period and 385 in the post-intervention period. The median cumulative mrem (interquartile range) for all staff combined in the pre-intervention period was 71 (28,75) and post-intervention period was 1 (0,3). The median mrem per procedure was significantly higher in the pre-intervention group 0.46 (0.36, 0.54) compared to post-intervention 0.01 (0.0.03); P < 0.01. The percentage reduction in overall effective dose per procedure to all staff was 97.3%. LIMITATIONS: Observational study, multiple radiation reduction interventions confound the individual effects of each intervention's effective dose CONCLUSIONS: Spinal injection technique and equipment changes in the procedure suite significantly reduced the rate of effective dose to the clinical staff.