Clinical trial NCT06554067: Effects of tDCS and VNS on Postoperative Analgesia
Official title: Effects of tDCS and VNS on Postoperative Analgesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Postoperative Pain
Keywords: Postoperative pain
Chronic Pain
Transcranial direct current stimulation
Vagus nerve stimulation
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a parallel-group, double blinded, randomized trial where 200 subjects will be randomized following a 2x2 structure.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or above with the capacity to provide informed consent who are undergoing an elective surgery requiring general anesthesia

Exclusion Criteria:

* cardiac bradyarrhythmia: taking beta-blockers;
* patients with metal implants around the chest, neck, or head (e.g. implantable pacemakers and defibrillators, deep brain stimulation devices);
* pregnancy
* history of epilepsy or seizures.
* patients undergoing surgical procedures involving the head, neck or spine, or those requiring the use of cardiopulmonary bypass

Primary outcomes:
measure: Pain levels using Numerical Rating Scale
timeFrame: Immediately before the intervention and immediately after the intervention.
measure: Pain levels using the Verbal Rating Scale
timeFrame: Immediately before the intervention and immediately after the intervention.
Secondary outcomes:
measure: Vital Signs: Blood pressure.
timeFrame: Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.
measure: Vital Signs: Heart rate
timeFrame: Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.
measure: Opioid consumption
timeFrame: 24 hours after surgery
measure: Time from surgery to discharge
timeFrame: From the date of the patient's surgery until the day of the discharge, up to 2 month.
Other outcomes:
Locations:
Study officials:
References: