Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06554067

Effects of tDCS and VNS on Postoperative Analgesia

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Acute Postoperative Pain Chronic Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Transcranial Direct Current Stimulation

Device

Ten minutes of active transcranial direct current stimulation

Other names: tDCS

Active vagus nerve stimulation

Device

Ten minutes of active vagus nerve stimulation

Other names: VNS

sham transcranial direct current stimulation

Other

Ten minutes of sham tDCS

Sham vagus nerve stimulation

Other

Ten minutes of sham VNS

Primary outcomes

  1. Pain levels using Numerical Rating Scale

    Time frame: 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.

  2. Pain levels using the Verbal Rating Scale

    Time frame: 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 outcomes

  1. Vital Signs: Blood pressure.

    Time frame: 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.

  2. Vital Signs: Heart rate

    Time frame: 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.

  3. Opioid consumption

    Time frame: 24 hours after surgery

    Patients that stay in hospital after surgery will be evaluated for opioid consumption from medical record.

  4. 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.

    Investigator will measure how long does the patient stay in the hospital after surgery in number of days.

Study contacts

Contact information is provided by the study sponsor or research team.

Oriana Lujan, MD

CONTACT

[email protected]

212-3047523

Paul S. Garcia, MD PhD

CONTACT

[email protected]

212-304-7523

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.