Health TrialsbyHealthPanel

Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery

ConditionsSpinal FusionHyperglycemiaPostoperative Pain ManagementPostoperative CareSpine DiseaseNeurologic DeficitsNeurological DisorderInflammationSpine ConditionSpinal (Fusion) SurgeryCytokine LevelsSpine Fusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexander T. Yahanda

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients <18 years of age

Shorter-segment spinal fusions than those described above

Undergoing current active cancer therapy

Undergoing treatment with immunosuppressive drugs

Trial design

Design model

Parallel

Treatments tested in this trial

  • Auricular vagus nerve stimulation

    Device

    Transcutaneous auricular vagal nerve stimulation

  • Sham Auricular Vagus nerve Stimulation

    Device

    Transcutaneous auricular vagal nerve stimulator applied without utilizing stimulating current.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Auricular vagal nerve stimulationExperimental treatment 1 intervention
Group B: Sham vagal nerve stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Inflammatory cytokine levels

The levels of 4 different inflammatory cytokines will be measured: interleukin-6 (IL-6), IL-1, IL-10, and tumor necrosis factor alpha (TNF-a) (all measured in pg/ml). Blood for these tests will be drawn preoperatively, postoperatively, on postop day 3, and postop day 6 (or time of discharge).

Time frame
5-10 days (depending on hospital admission length)

Secondary outcomes

1

Pain scores

Patient pain levels will be assessed twice daily using the visual analogue scale (VAS), a validated pain reporting scale that uses a 100-millimeter horizontal line with anchors at "no pain" (0) and "worst possible pain" (100). Patients draw a line along this spectrum to signify their pain level. Higher distance along the spectrum in a left-to-right direction indicates higher pain.

Time frame
5-10 days (depending on hospital admission length)
2

blood glucose levels

Glucose measurements will be obtained multiple times daily via bedside point-of-care testing as well as through daily CMP labs (in mg/dL).

Time frame
5-10 days (depending on hospital admission length)
3

Postoperative adverse events/complications

Investigators will track the incidence of postoperative adverse events or complications, including temporary radiculopathy or nerve stretch injury, deep vein thrombosis (DVT), pulmonary embolism (PE), acute kidney injury (AKI), ileus, wound healing problems, hospital delirium, transfusion reactions, and infections. All patients will receive screening lower extremity doppler (LED) studies before surgery and at time of hospital discharge.

Time frame
5-10 days (depending on hospital admission length)
4

Secondary markers of inflammation

Daily laboratory studies that serve as surrogate markers for the body's degree of systemic inflammation will be obtained. This includes labs such as CRP, cortisol, creatinine, and troponin (all in mg/dL)

Time frame
5-10 days (depending on hospital admission length)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexander T. Yahanda

Lead sponsor

Washington University School of Medicine

Sponsor institution

Source ClinicalTrials.gov
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