Auricular Vagal Nerve Stimulation for Spinal Fusion Surgery

(TAPIS Trial)

This trial aims to determine if auricular vagal nerve stimulation, a therapy involving nerve stimulation, can manage pain and inflammation after long-segment spinal fusion surgery. Researchers will compare real stimulation to a sham (fake) version to assess any true benefits. Candidates for this trial include those undergoing extensive spinal fusion surgery, specifically involving spinal segments from L2 to the pelvis or C2 to T2. Participants must be capable of undergoing reliable neurological and pain assessments. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to new pain management therapies.

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are undergoing treatment with immunosuppressive drugs.

Research has shown that auricular vagal nerve stimulation (aVNS) is generally safe. A review of several studies found that aVNS can be an effective and safe non-drug treatment for certain long-term health issues, typically without causing serious side effects.

Other studies have used aVNS as a non-opioid method for pain management, indicating its safety for most patients. Some individuals report mild discomfort at the device site, but adjusting the intensity often resolves this issue.

Researchers are excited about auricular vagal nerve stimulation for spinal fusion surgery because it offers a novel approach to managing pain and recovery. Unlike traditional pain management methods, which often rely on medications like opioids, this technique uses mild electrical impulses to stimulate the vagus nerve through the ear, potentially reducing pain and inflammation without the side effects of drugs. Additionally, the non-invasive delivery method, using adhesive contacts on the ear, provides a simple and patient-friendly alternative. This innovative method could enhance recovery times and improve patient outcomes after surgery.

Research has shown that stimulating the vagus nerve in the ear, known as auricular vagal nerve stimulation (VNS), might help manage pain and swelling after spinal fusion surgery. In this trial, participants will receive either actual VNS or a sham version to compare outcomes. Other studies have found that VNS may also reduce pain and improve outcomes for people with long-term back and stomach pain. By activating the vagus nerve, VNS can help control pain and inflammation in the body. Some patients have reported less swelling, better pain management, and improved blood sugar levels after receiving VNS. Although more research is needed specifically for spinal fusion, these findings suggest that VNS could aid in recovery and comfort after surgery.¹³⁶⁷⁸