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NCT Number: NCT07633444

Transauricular Vagus Nerve Stimulation Frequencies for Postoperative Pain

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.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitário Professor Edgard Santos, Federal University of Bahia (HUPES-UFBA)

Salvador, Estado de Bahia, 40170-110, Brazil

Location status: Recruiting

Location contact

João Paulo A Carvalho

CONTACT

[email protected]

75982953834

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transauricular Vagus Nerve Stimulation (tVNS)

Device

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 Transauricular Vagus Nerve Stimulation (sham tVNS)

Device

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.

Primary outcomes

  1. Total postoperative opioid consumption during the first 24 hours after surgery

    Time frame: 24 hours after surgery

    Total opioid consumption during the first 24 postoperative hours, recorded according to the institutional postoperative analgesia protocol.

Secondary outcomes

  1. Postoperative pain intensity (VAS)

    Time frame: 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.

  2. Rescue analgesic use

    Time frame: Within 24 hours after surgery

    Number of participants requiring rescue analgesics and total rescue analgesic administration during the first 24 postoperative hours.

  3. Postoperative nausea and vomiting (PONV)

    Time frame: Within 24 hours after surgery

    Incidence of postoperative nausea and/or vomiting and use of rescue antiemetic medication during the postoperative period.

  4. Heart rate changes

    Time frame: 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.

  5. Quality of Recovery (QoR-15 Score)

    Time frame: 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.

  6. Adverse events related to transauricular Vagus Nerve Stimulation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

João Paulo A de Carvalho

CONTACT

[email protected]

75 98295-3834

Rodrigo L Alves, MD, PhD

CONTACT

[email protected]

71 99961-9818

Sponsors and collaborators

Lead sponsor

Federal University of Bahia

Other

Collaborators

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

Registry information

Official study title

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

Acronym: TVNS-PAIN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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