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Effects of tDCS and VNS on Postoperative Analgesia

ConditionAcute Postoperative Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active transcranial direct current stimulation

    Device

    Ten minutes of active transcranial direct current stimulation

  • Active vagus nerve stimulation

    Device

    Ten minutes of active vagus nerve stimulation

  • Sham transcranial direct current stimulation

    Other intervention

    Ten minutes of sham tDCS

  • Sham vagus nerve stimulation

    Other intervention

    Ten minutes of sham VNS

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Group +/+Experimental treatment 2 interventions
Group B: Group +/-Active comparator 2 interventions
Group C: Group -/+Active comparator 2 interventions
Group D: Group -/-Sham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Pain levels using Numerical Rating Scale

Numerical Rating Scale (NRS) from 0-10. 0 being no pain, and 10 being the worse pain patient has experienced.

Time frame
Immediately before the intervention and immediately after the intervention.
2

Pain levels using the Verbal Rating Scale

Verbal Rating Scale (VRS) distinguishing between no pain, mild pain, moderate pain, and severe pain.

Time frame
Immediately before the intervention and immediately after the intervention.

Secondary outcomes

1

Vital Signs: Blood pressure.

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.

Time frame
Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.
2

Vital Signs: Heart rate

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 frame
Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.
3

Opioid consumption

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

Time frame
24 hours after surgery
4

Time from surgery to discharge

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

Time frame
From the date of the patient's surgery until the day of the discharge, up to 2 month.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: