1. 2012;15;131-140A Prospective Evaluation of Complications of 10,000 Fluoroscopically Directed Epidural Injections
   Prospective Evaluation
   Yogesh Malla, MD, Bradley W. Wargo, DO, Kimberly A. Cash, RT, Laxmaiah Manchikanti, MD, Vidyasagar Pampati, MSc, and Bert Fellows, MA.

BACKGROUND: Among the multiple modalities of treatments available in managing chronic spinal pain, including surgery and multiple interventional techniques, epidural injections by various routes, such as interlaminar epidural injections, caudal epidural injections, transforaminal epidural injections, and percutaneous adhesiolysis are common.

Even though the complications of fluoroscopically directed epidural injections are fewer than blind epidural injections, and have better effectiveness, multiple complications have been reported in scattered case reports, with only minor complications in randomized or non-randomized studies and systematic reviews. Thus, prospective studies with large patient series are essential to determine the types and incidences of complications.

STUDY DESIGN: A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009.

SETTING: A private interventional pain management practice, a specialty referral center in the United States.

OBJECTIVES: To assess the complication rate of fluoroscopically directed epidural injections.

METHODS: This study was carried out over a period of 20 months and included over 10,000 procedures: 39% caudal epidurals, 23% cervical interlaminar epidurals, 14% lumbar interlaminar epidurals, 13% lumbar transforaminal epidurals, 8% percutaneous adhesiolysis, and 3% thoracic interlaminar epidural procedures. All of the interventions were performed under fluoroscopic guidance in an ambulatory surgery center by one of 3 physicians. The complications encountered during the procedure and postoperatively were prospectively evaluated.

OUTCOMES ASSESSMENT: Measurable outcomes employed were intravascular entry of the needle, profuse bleeding, local hematoma, bruising, dural puncture and headache, nerve root or spinal cord irritation with resultant injury, infectious complications, vasovagal reactions, and facial flushing.

RESULTS: Intravascular entry was higher for adhesiolysis (11.6%) and lumbar transforaminal (7.9%) procedures compared to other epidurals which ranged from 0.5% for lumbar, 3.1% for caudal, 4% for thoracic, and 4.1% for cervical epidurals. Dural puncture was observed in a total of 0.5% of the procedures with 1% in the cervical region, 1.3% in the thoracic region, 0.8% with lumbar interlaminar epidurals, and 1.8% with adhesiolysis.

LIMITATIONS: Limitations of this study include a single-center study even though it included a large number of patients.

CONCLUSION: This study illustrates that major complications are rare and minor side effects are common.