Transcutaneous Auricular Neurostimulation After Lumbar Fusion Surgery

Not Applicable

Not yet recruiting

• Conditions: Pain, Postoperative; Opioid Use; Lumbar Spine Injury

• Registration Number: NCT06100172
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-9-14
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Medically cleared to undergo a lumbar fusion surgery<br><br> 2. 18-85 years of age<br><br> 3. English Proficiency<br><br> 4. Participants must be able to provide informed consent and function at an<br> intellectual level sufficient for study requirements<br><br>Exclusion Criteria:<br><br> 1. Current evidence of an uncontrolled and/or clinically significant medical condition<br><br> 2. History of bleeding disorders or coagulopathy<br><br> 3. History of seizures or epilepsy<br><br> 4. History of neurological diseases or traumatic brain injury<br><br> 5. Use of illegal recreational drugs<br><br> 6. Presence of devices, e.g. pacemakers, cochlear prosthesis, neuro-stimulators<br><br> 7. Use of acupuncture within 4 weeks of surgery<br><br> 8. Grossly abnormal external ear anatomy or active ear infection<br><br> 9. Women of childbearing potential, not using effective contraception per investigator<br> judgment or not willing to comply with contraception for the duration of the study<br><br> 10. Females who are pregnant or lactating<br><br> 11. Any other significant disease or disorder which, in the opinion of the Investigator,<br> may either put the participants at risk because of participation in the trial, or<br> may influence the result of the trial, or the participant's ability to participate<br> in the trial

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 3 hours post-operation;Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at 6 hours post-operation;Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 2 post-operation;Change From Baseline in Pain Scores on the Visual Analog Scale (VAS) at day 14 post-operation

Secondary Outcome Measures

Name	Time	Method
Mean total postoperative opioid consumption (morphine equivalent dose) at 3 hours post-surgery;Mean total postoperative opioid consumption (morphine equivalent dose) at 6 hours post-surgery;Mean total postoperative opioid consumption (morphine equivalent dose) at Day 2 post-surgery;Mean total postoperative opioid consumption (morphine equivalent dose) at Day 7 post-surgery;Mean total postoperative opioid consumption (morphine equivalent dose) at Day 14 post-surgery;Mean percent change in C-reactive protein (CRP) levels from baseline at Day 1 (intra-op);Mean percent change in C-reactive protein (CRP) levels from baseline at 6 hours post-op;Mean percent change in C-reactive protein (CRP) levels from baseline at Day 2 post-op;Mean percent change in TNF-alpha levels from baseline at Day 1 (intra-op);Mean percent change in TNF-alpha levels from baseline at 6 hours post-op;Surgery time (incision to closure);Estimated mean total blood loss