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Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery

RecruitingNA

Sponsor: Alexander T. Yahanda

Conditions: Spinal Fusion, Hyperglycemia, Postoperative Pain Management, Postoperative Care, Spine Disease

Interventions: Auricular vagus nerve stimulation, Sham Auricular Vagus nerve Stimulation

Countries: United States

This study is a randomized controlled trial that will evaluate the effect of non-invasive auricular vagal nerve stimulation on inflammatory markers, glycemic control, postoperative pain, and inflammation-related clinical outcomes after long-segment spinal fusion surgeries when compared to current accepted management.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Long-segment spinal fusions (defined as constructs spanning at least L2-pelvis for thoracolumbar fusions or C2-T2 for cervical fusions)
* Ability to undergo a reliable neurologic examination and pain assessments

Exclusion Criteria:

* Patients \<18 years of age
* Shorter-segment spinal fusions than those described above
* Undergoing current active cancer therapy
* Undergoing treatment with immunosuppressive drugs
* Additional spinal surgery within past 6 months
* Sustained bradycardia or presence of pacemaker
* History of substance abuse

Locations (1)

St Louis, Missouri, United States