Effects of tDCS and VNS on Postoperative Analgesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active transcranial direct current stimulation, Active vagus nerve stimulation, Sham transcranial direct current stimulation, Sham vagus nerve stimulation.
- Who it may be relevant to
- Registry conditions: Acute Postoperative Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Pain levels using Numerical Rating Scale [Time frame: Immediately before the intervention and immediately after the intervention.]
- Pain levels using the Verbal Rating Scale [Time frame: Immediately before the intervention and immediately after the intervention.]
Secondary outcome measures (4)
- Vital Signs: Blood pressure. [Time frame: Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.]
- Vital Signs: Heart rate [Time frame: Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.]
- Opioid consumption [Time frame: 24 hours after surgery]
- Time from surgery to discharge [Time frame: From the date of the patient's surgery until the day of the discharge, up to 2 month.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06554067 · AAAV2033