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Transauricular Vagus Nerve Stimulation Frequencies for Postoperative Pain

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07633444
Acronym
TVNS-PAIN
Enrollment
174
Registered
2026-06-08
Start date
2026-06-01
Completion date
2026-12-04
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Postoperative Pain, Transauricular Vagus Nerve Stimulation, tVNS, Neuromodulation, Opioid Consumption, Pain Management, Randomized Controlled Trial

Brief 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.

Detailed description

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.

Interventions

DEVICETransauricular 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.

DEVICESham 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

Federal University of Bahia
Lead SponsorOTHER
Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Participants, outcome assessors, and data analysts will remain blinded to treatment allocation throughout the study. The researcher responsible for administering the stimulation will not be blinded because intervention assignment is required for device setup and delivery.

Intervention model description

Participants will be randomly assigned in a 1:1:1 ratio to receive high-frequency transauricular vagus nerve stimulation (60-120 Hz), low-frequency transauricular vagus nerve stimulation (10-20 Hz), or sham stimulation. Each participant will remain in the assigned group throughout the study and will receive two stimulation sessions, one before anesthesia and one after surgery. Outcomes will be compared across the three parallel groups.

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Total postoperative opioid consumption during the first 24 hours after surgery24 hours after surgeryTotal opioid consumption during the first 24 postoperative hours, recorded according to the institutional postoperative analgesia protocol.

Secondary

MeasureTime frameDescription
Postoperative pain intensity (VAS)Before stimulation in the post-anesthesia care unit, immediately after stimulation, 2 hours after surgery, and 24 hours after surgeryPain 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.
Rescue analgesic useWithin 24 hours after surgeryNumber of participants requiring rescue analgesics and total rescue analgesic administration during the first 24 postoperative hours.
Postoperative nausea and vomiting (PONV)Within 24 hours after surgeryIncidence of postoperative nausea and/or vomiting and use of rescue antiemetic medication during the postoperative period.
Heart rate changesImmediately 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.
Quality of Recovery (QoR-15 Score)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.
Adverse events related to transauricular Vagus Nerve StimulationFrom 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.

Countries

Brazil

Contacts

CONTACTRodrigo L Alves, MD, PhD
rlalves@ufba.br71 99961-9818
CONTACTJoão Paulo A de Carvalho
joaoaureliano@ufba.br75 98295-3834
PRINCIPAL_INVESTIGATORRodrigo M Vieira, MD

Botucatu Medical School, São Paulo State University (UNESP)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026