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

7. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

174

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studer Kontakt Backup

Studiesteder

  • Brasil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasil, 40170-110
        • Rekruttering
        • Hospital Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA)
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Eksperimentell: 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.
Enhet: 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.
Sham-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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total postoperative opioid consumption during the first 24 hours after surgery
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative pain intensity (VAS)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Federal University of Bahia

Samarbeidspartnere

Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

30. november 2026

Studiet fullført (Antatt)

4. desember 2026

Datoer for studieregistrering

Først innsendt

2. juni 2026

Først innsendt som oppfylte QC-kriteriene

2. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 96691226.0.0000.0049 (Registeridentifikator: 8.416.413)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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