Noninvasive Auricular Vagal Nerve Stimulation to Reduce Inflammation and Pain After Long-Segment Spinal Fusion Surgery

What this Trial Is About

Researchers are evaluating the effect of non-invasive auricular vagal nerve stimulation VNS on inflammatory markers, blood sugar control, postoperative pain, and inflammation-related outcomes after long-segment spinal fusion surgeries. This randomized controlled trial compares the use of auricular VNS plus accepted perioperative care against accepted care plus a sham stimulus. The study aims to address the significant postoperative inflammation and complications common in these extensive spine surgeries, which currently lack effective non-drug treatments. Participants will be randomly assigned to receive either real auricular VNS or a sham device. The VNS device is applied to the left ear and delivers stimulation twice on the surgery day once before surgery and then twice daily during the hospital stay. Each stimulation session lasts 20 minutes with specific parameters for frequency and intensity, which can be adjusted for comfort. The sham group will have the device applied but will not receive active stimulation. During the 5 to 10 days of hospital admission, researchers will collect blood samples to measure inflammatory cytokines and other markers, monitor pain scores, blood glucose, heart rate, blood pressure, opioid use, and insulin needs. They will also track postoperative complications, hospital stay length, discharge disposition, and readmissions up to 60 days after surgery. These assessments aim to understand how VNS affects inflammation and recovery in patients undergoing these complex spinal procedures.

Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery