Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554067
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Effects of tDCS and VNS on Postoperative Analgesia
Sponsor:
None
Organization:
None
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:
No
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
Patients 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
Patients 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None