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Transauricular Vagus Nerve Stimulation Frequencies for Postoperative Pain

NCT07633444 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2026-06-10

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether different frequencies of transauricular vagus nerve stimulation (tVNS) can reduce postoperative pain and opioid consumption in adults undergoing abdominal or urologic surgery. It will also evaluate the effects of tVNS on recovery quality, autonomic function, and treatment safety. The main questions it aims to answer are:

Does transauricular vagus nerve stimulation reduce postoperative opioid consumption during the first 24 hours after surgery? Do different stimulation frequencies (high-frequency and low-frequency tVNS) produce different effects on postoperative pain and autonomic responses? Is transauricular vagus nerve stimulation safe and well tolerated in surgical patients?

Researchers will compare high-frequency tVNS, low-frequency tVNS, and sham stimulation (inactive stimulation) to determine their effects on postoperative pain and opioid requirements.

Participants will:

Be randomly assigned to receive high-frequency tVNS, low-frequency tVNS, or sham stimulation.

Receive two 30-minute stimulation sessions, one before anesthesia and one after surgery in the post-anesthesia care unit.

Undergo assessments of postoperative pain, opioid consumption, need for rescue analgesics, postoperative nausea and vomiting, heart rate changes, and quality of recovery.

Be monitored for adverse events related to the intervention during the study period.

A total of 174 participants will be enrolled in this single-center, randomized, double-blind, sham-controlled clinical trial.

Conditions

  • Postoperative Pain
  • Postoperative Nausea and Vomiting (PONV)
  • Opioid Consumption, Postoperative

Interventions

DEVICE

Transauricular Vagus Nerve Stimulation (tVNS)

Non-invasive electrical stimulation of the auricular branch of the vagus nerve applied bilaterally through ear electrodes. Stimulation is delivered before anesthesia and after surgery using predefined frequency settings.

DEVICE

Sham Transauricular Vagus Nerve Stimulation (sham tVNS)

Sham stimulation delivered using the same device and electrode placement as active stimulation. The device is activated to mimic treatment but does not deliver therapeutic electrical stimulation.

Sponsors & Collaborators

  • Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

    collaborator OTHER

  • Federal University of Bahia

    lead OTHER

Principal Investigators

  • Rodrigo M Vieira, MD · Botucatu Medical School, São Paulo State University (UNESP)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-11-30
Completion
2026-12-04

Countries

  • Brazil

Study Locations

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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 NCT07633444 on ClinicalTrials.gov