Effects of tDCS and VNS on Postoperative Analgesia

August 12, 2024 updated by: Paul Garcia, Columbia University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group +/+
Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.
Device: Active transcranial direct current stimulation
Ten minutes of active transcranial direct current stimulation
Other Names:
  • tDCS
Device: Active vagus nerve stimulation
Ten minutes of active vagus nerve stimulation
Other Names:
  • VNS
Active Comparator: Group +/-
Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.
Device: Active transcranial direct current stimulation
Ten minutes of active transcranial direct current stimulation
Other Names:
  • tDCS
Other: Sham vagus nerve stimulation
Ten minutes of sham VNS
Active Comparator: Group -/+
Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.
Device: Active vagus nerve stimulation
Ten minutes of active vagus nerve stimulation
Other Names:
  • VNS
Other: Sham transcranial direct current stimulation
Ten minutes of sham tDCS
Sham Comparator: Group -/-
Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.
Other: Sham vagus nerve stimulation
Ten minutes of sham VNS
Other: Sham transcranial direct current stimulation
Ten minutes of sham tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Verbal Rating Scale (VRS) distinguishing between no pain, mild pain, moderate pain, and severe pain.
Immediately before the intervention and immediately after the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
Immediately before and immediately after intervention. Then, every 5 minutes until one hour after the intervention.
Opioid consumption
Time Frame: 24 hours after surgery
Patients that stay in hospital after surgery will be evaluated for opioid consumption from medical record.
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.
Investigator will measure how long does the patient stay in the hospital after surgery in number of days.
From the date of the patient's surgery until the day of the discharge, up to 2 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAV2033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared in aggregate form. There is no plan to share individual participant data (IPD) with researchers not involved with the study design. Several posthoc analyses are being planned for retrospective analysis of the data obtained.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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