Effects of tDCS and VNS on Postoperative Analgesia

NCT06554067 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: AAAV2033
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Postoperative Pain

Keywords

Postoperative pain; Chronic Pain; Transcranial direct current stimulation; Vagus nerve stimulation

Outcome Measures

Primary Outcomes (2)

• 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.

  Immediately before the intervention and immediately after the intervention.

• Pain levels using the Verbal Rating Scale

  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 Outcomes (4)

• Vital Signs: Blood pressure.

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

• Vital Signs: Heart rate

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

• Opioid consumption

  24 hours after surgery

• Time from surgery to discharge

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

Study Arms (4)

Group +/+

EXPERIMENTAL

Group +/+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.

Device: Active transcranial direct current stimulation; Device: Active vagus nerve stimulation

Group +/-

ACTIVE COMPARATOR

Group +/- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.

Device: Active transcranial direct current stimulation; Other: Sham vagus nerve stimulation

Group -/+

ACTIVE COMPARATOR

Group -/+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.

Device: Active vagus nerve stimulation; Other: Sham transcranial direct current stimulation

Group -/-

SHAM COMPARATOR

Group -/- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.

Other: Sham transcranial direct current stimulation; Other: Sham vagus nerve stimulation

Interventions

Active transcranial direct current stimulation DEVICE

Ten minutes of active transcranial direct current stimulation

Also known as: tDCS

Group +/+; Group +/-

Active vagus nerve stimulation DEVICE

Ten minutes of active vagus nerve stimulation

Also known as: VNS

Group +/+; Group -/+

Sham transcranial direct current stimulation OTHER

Ten minutes of sham tDCS

Group -/+; Group -/-

Sham vagus nerve stimulation OTHER

Ten minutes of sham VNS

Group +/-; Group -/-

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Paul S. Garcia, MD PhD

CONTACT

212-304-7523; pg2618@cumc.columbia.edu

Oriana Lujan, MD

CONTACT

212-3047523; ol2274@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will be assigned a Study ID that will determine the assigned procedure. At the study's completion the blind will be broken, and data will be turned over for analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology, Division Chief of Neuroanesthesia

Model Details: This is a parallel-group, double blinded, randomized trial where 200 subjects will be randomized following a 2x2 structure.

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 14, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share