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Effects of tDCS and VNS on Postoperative Analgesia

NCT06554067 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-08-14

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2025-08-31
Completion
2026-08-31
FDA Device
Yes

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06554067 on ClinicalTrials.gov