Effects of tDCS and VNS on Postoperative Analgesia
- Conditions
- Acute Postoperative Pain
- Interventions
- Other: Sham transcranial direct current stimulationDevice: Active transcranial direct current stimulationDevice: Active vagus nerve stimulationOther: Sham vagus nerve stimulation
- Registration Number
- NCT06554067
- Lead Sponsor
- Columbia University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Adults aged 18 years or above with the capacity to provide informed consent who are undergoing an elective surgery requiring general anesthesia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group -/- Sham transcranial direct current stimulation Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS. Group +/+ Active transcranial direct current stimulation Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS. Group +/+ Active vagus nerve stimulation Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS. Group +/- Sham vagus nerve stimulation Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS. Group -/+ Active vagus nerve stimulation Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS. Group -/- Sham vagus nerve stimulation Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS. Group +/- Active transcranial direct current stimulation Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS. Group -/+ Sham transcranial direct current stimulation Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.
- Primary Outcome Measures
Name Time Method Pain levels using Numerical Rating Scale Immediately before the intervention and immediately after the intervention. Numerical Rating Scale (NRS) from 0-10. 0 being no pain, and 10 being the worse pain patient has experienced.
Pain levels using the Verbal Rating Scale Immediately before the intervention and immediately after the intervention. Verbal Rating Scale (VRS) distinguishing between no pain, mild pain, moderate pain, and severe pain.
- Secondary Outcome Measures
Name Time Method Vital Signs: Blood pressure. Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention. Patients at the PACU are under continuous monitoring of vital signs. We will collect the values of the blood pressure in mmHg. A high score (higher than 130/80) will indicate a bad outcome.
Vital Signs: Heart rate Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention. Patients at the PACU are under continuous monitoring of vital signs. We will collect the values of the heart rate before the intervention and after. A result higher than what is physiologic normal (100) will indicate a bad outcome.
Time from surgery to discharge From the date of the patient's surgery until the day of the discharge, up to 2 month. Investigator will measure how long does the patient stay in the hospital after surgery in number of days.
Opioid consumption 24 hours after surgery Patients that stay in hospital after surgery will be evaluated for opioid consumption from medical record.