Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT06554067
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of tDCS and VNS on Postoperative Analgesia
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Effects of tDCS and VNS on Postoperative Analgesia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: