NCT06554067

Effects of tDCS and VNS on Postoperative Analgesia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study seeks to evaluate the efficacy of transcranial direct current stimulation (tDCS) and Afferent Vagus nerve simulation (VNS) in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery. Study outcomes will include changes in pain levels and vital signs. For patients who are admitted after surgery, opioid consumption in the 24 hours after surgery and time from surgery to discharge are recorded as secondary outcomes. Patients will be divided in the following comparison groups: * Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS. * Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS. * Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS. * Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.

Detailed description

Two nonpharmacologic interventions have shown promise in treatment of chronic pain. Afferent Vagus nerve simulation (VNS) can modulate nociception, even though the exact mechanism is unclear. Clinically, it has found uses in chronic pain as well as early evidence of potential use in postoperative pain. Alternatively, transcranial direct current stimulation (tDCS) is a form of non-invasive and polarity-specific technique of modulating neuronal circuitry using a weak electric current delivered by a battery. tDCS has also been shown to modulate chronic pain and has been shown to produce EEG signatures similar to those seen in states of adequate intraoperative analgesia. This study seeks to evaluate the efficacy of tDCS and VNS in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery by randomizing 200 subjects in 4 groups: * Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS. * Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS. * Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS. * Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS. Patient's vital signs and pain level will be obtained before the procedure and after. Patients that have to stay in hospital will also be evaluated by opioid consumption and time from surgery to discharge.

Conditions

• Acute Postoperative Pain

Interventions

Type	Name	Description
DEVICE	Active transcranial direct current stimulation	Ten minutes of active transcranial direct current stimulation
DEVICE	Active vagus nerve stimulation	Ten minutes of active vagus nerve stimulation
OTHER	Sham transcranial direct current stimulation	Ten minutes of sham tDCS
OTHER	Sham vagus nerve stimulation	Ten minutes of sham VNS

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2024-08-14
• Last updated: 2024-08-14

Regulatory

• FDA-regulated device study