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Transauricular Vagus Nerve Stimulation Frequencies for Postoperative Pain (TVNS-PAIN)

7. Juni 2026 aktualisiert von: Joao Paulo Aureliano de Carvalho, Federal University of Bahia

Effects of Different Frequencies of Transauricular Vagus Nerve Stimulation on Postoperative Pain: A Randomized, Double-Blind, Sham-Controlled Trial With Preoperative and Postoperative Sessions

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Postoperative pain remains a major challenge in perioperative care and is associated with delayed recovery, increased healthcare utilization, and greater opioid consumption. Despite advances in multimodal analgesia, opioid medications continue to play a central role in postoperative pain management and may be associated with adverse effects such as nausea, vomiting, respiratory depression, and prolonged recovery. Therefore, the development of effective non-pharmacological adjunctive strategies is of considerable clinical interest.

Transauricular vagus nerve stimulation (tVNS) is a non-invasive neuromodulation technique that stimulates the auricular branch of the vagus nerve through the external ear. Experimental and clinical studies suggest that vagal stimulation may modulate pain perception through activation of central autonomic pathways, enhancement of descending inhibitory pain mechanisms, and regulation of inflammatory responses. Previous clinical trials have demonstrated promising effects of tVNS on acute and chronic pain conditions, including reductions in postoperative pain scores.

However, the optimal stimulation parameters for perioperative analgesia remain uncertain. In particular, the influence of stimulation frequency on clinical outcomes and autonomic responses has not been adequately investigated. Different stimulation frequencies may activate distinct neural pathways and produce different effects on pain modulation and autonomic regulation.

This study is designed to evaluate the effects of different frequencies of transauricular vagus nerve stimulation applied before and after surgery in adult patients undergoing elective surgical procedures. In addition to assessing postoperative opioid requirements, the study will explore the relationship between autonomic responses and postoperative recovery. The findings may contribute to the optimization of non-pharmacological analgesic strategies and support the incorporation of transauricular vagus nerve stimulation into multimodal perioperative pain management protocols.

Studientyp

Interventionell

Einschreibung (Geschätzt)

174

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Rodrigo L Alves, MD, PhD
  • Telefonnummer: 71 99961-9818
  • E-Mail: rlalves@ufba.br

Studieren Sie die Kontaktsicherung

Studienorte

  • Brasilien
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasilien, 40170-110
        • Rekrutierung
        • Hospital Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA)
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Adults aged 18 to 59 years.
  • Undergoing elective abdominal or urologic surgery.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Able and willing to provide written informed consent.

Exclusion Criteria:

  • History of neurological disorders.
  • History of psychiatric disorders.
  • Inability to understand study procedures.
  • Pregnancy.
  • Cognitive impairment.
  • Communication difficulties that interfere with study assessments.
  • Auricular dermatitis or skin lesions at the stimulation site.
  • Pre-existing cardiac arrhythmia.
  • Chronic opioid use.
  • Implanted electronic medical devices, including pacemakers.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: High-Frequency tVNS
Participants will receive active transauricular vagus nerve stimulation (tVNS) at a frequency of 60-120 Hz. Stimulation will be applied bilaterally to the auricular branch of the vagus nerve for 30 minutes before anesthesia and for 30 minutes after surgery. Current intensity will be adjusted between 2 and 6 mA according to participant tolerance.
Gerät: 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.
Experimental: Low-Frequency tVNS
Participants will receive active transauricular vagus nerve stimulation (tVNS) at a frequency of 10-20 Hz. Stimulation will be applied bilaterally to the auricular branch of the vagus nerve for 30 minutes before anesthesia and for 30 minutes after surgery. Current intensity will be adjusted between 2 and 6 mA according to participant tolerance.
Gerät: 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.
Schein-Komparator: Sham tVNS
Participants will receive sham transauricular vagus nerve stimulation. The device will be positioned and activated to mimic active treatment, but stimulation will be discontinued shortly after initiation. Participants will undergo two 30-minute sessions, one before anesthesia and one after surgery, while maintaining blinding to treatment allocation.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Total postoperative opioid consumption during the first 24 hours after surgery
Zeitfenster: 24 hours after surgery
Total opioid consumption during the first 24 postoperative hours, recorded according to the institutional postoperative analgesia protocol.
24 hours after surgery

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Postoperative pain intensity (VAS)
Zeitfenster: Before stimulation in the post-anesthesia care unit, immediately after stimulation, 2 hours after surgery, and 24 hours after surgery
Pain intensity measured using a 100-mm Visual Analog Scale (VAS). Pain scores will be assessed at predefined postoperative time points and compared among study groups.
Before stimulation in the post-anesthesia care unit, immediately after stimulation, 2 hours after surgery, and 24 hours after surgery
Rescue analgesic use
Zeitfenster: Within 24 hours after surgery
Number of participants requiring rescue analgesics and total rescue analgesic administration during the first 24 postoperative hours.
Within 24 hours after surgery
Postoperative nausea and vomiting (PONV)
Zeitfenster: Within 24 hours after surgery
Incidence of postoperative nausea and/or vomiting and use of rescue antiemetic medication during the postoperative period.
Within 24 hours after surgery
Heart rate changes
Zeitfenster: Immediately before and immediately after each stimulation session (preoperative and postoperative).
Changes in heart rate measured immediately before and immediately after transauricular vagus nerve stimulation sessions as an indicator of autonomic nervous system activity.
Immediately before and immediately after each stimulation session (preoperative and postoperative).
Quality of Recovery (QoR-15 Score)
Zeitfenster: Baseline (preoperative) and 24 hours after surgery.
Quality of postoperative recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15). Higher scores indicate better recovery.
Baseline (preoperative) and 24 hours after surgery.
Adverse events related to transauricular Vagus Nerve Stimulation
Zeitfenster: From the first stimulation session until 24 hours after surgery.
Incidence of adverse events potentially related to the intervention, including auricular discomfort, skin irritation, headache, bradycardia, hypotension, bronchospasm, or other treatment-related events.
From the first stimulation session until 24 hours after surgery.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Federal University of Bahia

Mitarbeiter

Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

30. November 2026

Studienabschluss (Geschätzt)

4. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

2. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juni 2026

Zuerst gepostet (Tatsächlich)

8. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 96691226.0.0000.0049 (Registrierungskennung: 8.416.413)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

De-identified individual participant data underlying the results reported in publications arising from this study will be made available, including demographic characteristics, intervention allocation, primary and secondary outcome measures, and adverse event data. Data will be shared only after removal of all direct identifiers to protect participant confidentiality.

IPD-Sharing-Zeitrahmen

De-identified individual participant data and supporting study documents will be available beginning 3 months after publication of the primary study results and will remain available indefinitely, with no end date.

IPD-Sharing-Zugriffskriterien

De-identified data will be available to qualified researchers who provide a methodologically sound research proposal. Requests should be submitted to the principal investigator. Access will be granted following review and approval of the proposed use and execution of a data-sharing agreement.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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