Biplane Ultrasound Versus Fluoroscopy for Guidance of Percutaneous Lumbar Intervertebral Foramen Insertion : A Randomized Controlled Clinical Trial.

Abstract

A randomized controlled study. The aim of this study was to develop a clinical process of biplane ultrasound (US) guided percutaneous lumbar intervertebral foramen insertion (PLIFI) and to verify that biplane US can improve accuracy and reduce number of fluoroscopies. PLIFI is crucial for drug injection and establishment of transforaminal surgical channel. The traditional fluoroscopy guidance involves radiation and requires practical experience. Patients with lumbar disc herniation scheduled for an epidural steroid injection or percutaneous endoscopic lumbar discectomy were randomized to the biplane US and fluoroscopy groups. The biplane US group was divided into training and proficiency stages using a learning curve fitted by cumulative sum analysis. All punctures were performed by a junior spine surgeon and a junior sonographer. The primary outcomes were the first success rate, number of punctures and radiographs, puncture time, and confidence score. Sixty-eight patients (age 51.4±15.4 yr, 36 males) were divided into the biplane US and fluoroscopy groups. According to the 12th turning point of a learning curve, the biplane US group was divided into training and proficiency periods. The first-attempt success rate was achieved in 61% using biplane US at the proficiency period, compared with 32% using fluoroscopy [ P =0.033, RR: 1.634]. The number of radiographies [1 (IQR 1-2) vs . 2 (IQR 2-3), P =0.001] was significantly smaller, and puncture time [120 s (IQR 57-210) vs. 197 s (IQR 159-341), P =0.001] was significantly faster using biplane US at the proficiency period. Biplane US provides an accurate, safe, and convenient approach for PLIFI. With further clinical practice, biplane US would be conducive to rapid skill acquisition for novices and has the potential to achieve a completely radiation-free puncture process.