Transcutaneous Auricular Neurostimulation After Lumbar Fusion Surgery

Pain, Postoperative Clinical Trial

Official title: Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study, entitled "Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Fusion Surgery", is to demonstrate whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients undergoing lumbar fusion surgery. tAN is placed on and around the ear to non-invasively stimulate branches of the vagus and trigeminal nerves and modulate specific brain regions associated with pain.

Clinical Trial Description

This study is designed as a randomized, double-blind, sham-controlled, single-center, clinical trial in which 20 patients undergoing lumbar fusion surgery will be randomized 1:1 into one of two treatment groups:

1. Group 1 (n=10): Active tAN + standard care

2. Group 2 (n=10): Sham tAN + standard care

Stimulation:

Participants undergoing lumbar fusion surgery will be randomized to receive either active or sham tAN treatment according to the following time points:

• Pre-operative: 30 minutes in the hour prior to surgery

• Intra-operative: 30 minutes before the end of surgery

• Post-operative: 30 minutes at 3 and 6 hours after surgery

• Inpatient: Four 30-minute sessions on Day 2

Blood Draws

Participants will have blood samples collected at the following time points:

• Day 1 (Day of Surgery)

• Day 2 (Day 1 post-surgical)

Follow up Visits Participants will have study follow up visits on Days 7 and Day 14. These visits can either be conducted either via a secure telehealth video visit, or in person visit. ;

Related Conditions & MeSH terms

• Lumbar Spine Injury
• Opioid Use
• Pain, Postoperative
• Spinal Injuries

• NCT number: NCT06100172
• Study type: Interventional
• Source: University of Texas Southwestern Medical Center
• Contact: Alex Valadka, MD
• Phone: 214-645-2300
• Email: alex.valadka@utsouthwestern.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Completion date: March 2025