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Postoperative Pain, AcuteNCT06912399

Effect of Transauricular Vagus Nerve Stimulation on Postoperative Pain Management in Video Assisted Thoracic Surgery

A study testing Transauricular Vagus Nerve Stimulation in people with Postoperative Pain, Acute and VATS, run by Peking Union Medical College Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Transcutaneous auricular vagus nerve stimulation (taVNS) is a novel pain management technique that has gained popularity in recent years due to its non-invasive nature and ease of operation. Current literature has substantiated its efficacy in managing pain syndromes and chronic pain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Pain, Acute, VATS
What is being tested?
Transauricular Vagus Nerve Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
116 participants
Where
1 siteChina
Study dates
25 Mar 2025to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older;
  • ASA classification I-III;
  • No prior taVNS treatment;
  • Scheduled to undergo VATS (including segmentectomy and lobectomy);
  • VAS ≥ 30 mm at any time on the day of surgery;
  • Patients and their families can understand the study design and are willing to cooperate and participate in the study.

Who cannot join

  • Psychiatric disorders or other conditions that prevent cooperation;
  • Long-term use of steroids or opioids;
  • Scheduled for bilateral VATS surgery;
  • History of thoracic surgery;
  • History of chronic pain, autoimmune diseases, or persistent infections.
  • Withdrawl Criteria:
Show all 10Show fewer
  • Patient request;
  • Surgery cancellation or change in surgical method resulting in failure to meet inclusion criteria;
  • Severe perioperative complications and adverse events;
  • Severe intervention-related adverse events.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing

    Li Jiayue, 0086-010-69156874

Other trials in China

About this study

Official title: Effect of Transauricular Vagus Nerve Stimulation on Postoperative Pain Management in Video Assisted Thoracic Surgery: a Randomized Controlled Clinical Trial

Transcutaneous auricular vagus nerve stimulation (taVNS) is a novel pain management technique that has gained popularity in recent years due to its non-invasive nature and ease of operation. Current literature has substantiated its efficacy in managing pain syndromes and chronic pain. However, there is a paucity of evidence regarding its effectiveness in treating acute postoperative pain. This project aims to explore the efficacy of taVNS in postoperative pain management, with a focus on video-assisted thoracic surgery(VATS). The investigators have designed a double-blind, single-center, randomized controlled clinical trial, planning to enroll 116 patients scheduled to undergo VATS(including segmentectomy or lobectomy) under general anesthesia at Peking Union Medical College Hospital. Participants will be divided into an intervention group (receiving taVNS) and a sham intervention group (receiving sham-taVNS), and will undergo a 2-hour intervention on the first postoperative day. The primary outcome is the pain relief rate, defined as a reduction of 15mm or 30% in the VAS (1-100mm) score immediately before and after the intervention on the first postoperative day. Secondary outcomes include: the proportion of patients with inadequate analgesia within three days after intervention; the difference in VAS scores immediately before and after the intervention on the first postoperative day; the incidence of opioid-related and taVNS-related side effects from the first to the third postoperative day after intervention; the number of effective and ineffective PCA presses (if used) from the first to the third postoperative day after intervention; the specifics and frequency of additional analgesic measures taken by patients from the first to the third postoperative day after intervention; the difference in RCSQ scores on the night of surgery and the night after intervention; and the probability of patients experiencing surgery-related pain three months after surgery. Follow-up period for this study will be three months after surgery.

Being tested
Transauricular Vagus Nerve Stimulation, Sham Transauricular Vagus Nerve stimulation
Keywords
TaVNS, Postopearvie pain, VATS
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transauricular Vagus Nerve StimulationDevice

    Also called taVNS

    Participants enrolled will have a commercial transcutaneous electrical nerve stimulation unit (tVNS501,RISHENA,Changzhou,China) attached to their left outer ear after VATS. The stimulation pulses will target at the cymba concha which is 100% dominated by the auricular branch of the vagus nerve. Stimulation pulses will be 25Hz in frequency according to current clinical research, 500µs in pulse width which has been suggested to be most biologically active, with its amplitude increasing to the maximum amount that the patients can tolerate without pain.

  • Sham Transauricular Vagus Nerve stimulationDevice

    Also called Sham-taVNS

    The only thing differs with the taVNS group is that the device will automatically shut down after running for 15 seconds.

Study groups in NCT06912399
Study groupRoleWhat they receive
taVNS group.ExperimentalPaticipants in this arm will undergo a 2-hour intervention of taVNS on the first postoperative day.
Receives: Device: Transauricular Vagus Nerve Stimulation
sham-taVNS group.Sham comparatorPaticipants in this arm will undergo a 2-hour sham-intervention of taVNS on the first postoperative day.
Receives: Device: Sham Transauricular Vagus Nerve stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Relief Rate

    Pain relief rate is defined as a reduction of 15mm or 30% in the VAS (Visual Analogue Scale, 1-100mm) score immediately before and after the intervention on the first postoperative day

    Measured: First postoperative day

Secondary outcomes (7)
  1. The proportion of patients with inadequate analgesia within three days after intervention

    "Inadequate analgesia" is defined as: 1) VAS ≥ 40 mm at any time within three days after the intervention; or 2) the need for additional analgesic medication in the ward after the intervention, or the occurrence of ineffective PCA presses. Meeting either of the above criteria satisfies the definition.

    Measured: Within three days after the intervention

  2. The difference in VAS scores immediately before and after the intervention on the first postoperative day

    Measured: First postoperative day

  3. The incidence of opioid-related and taVNS-related side effects from the first to the third postoperative day after intervention

    Measured: First to the third postoperative day

  4. The number of effective and ineffective PCA attempts (if used) from the first to the third postoperative day after intervention

    Measured: First to the third postoperative day

  5. The specifics and frequency of additional analgesic measures taken by patients from the first to the third postoperative day after intervention

    The investigators will document any additional analgesic measures taken by the patients within three days after the intervention, including:

    The name, dosage, and administration method of analgesic medications; The formulation and settings of patient-controlled analgesia (PCA) pumps, along with the counts of effective and ineffective PCA attempts; Any physical analgesic measures employed.

    Measured: First to the third postoperative day

  6. The difference in RCSQ scores on the night of surgery and the night after intervention

    Measured: First to second postoperative day

  7. The probability of patients experiencing surgery-related pain three months after surgery

    The investigators will conduct a telephone follow-up with participants three months later to assess whether they still experience surgery-related pain after discharge. The outcome will be recorded as "yes" or "no" based on the patient's subjective description.

    Measured: Three months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2025
  2. Study start25 Mar 2025 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06912399
Sponsor's protocol ID
K7040
Status last verified
Mar 2025
First submitted
19 Mar 2025
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Considering patients' privacy and the measures for protecting participants, we do not plan to disclose patients' personal data.

Publications

  • Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.

    PubMed 18456219
  • Zhou Q, Yu L, Yin C, Zhang Q, Tai Y, Zhu L, Dong J, Wang Q. Effect of Transauricular Vagus Nerve Stimulation on Rebound Pain After Ropivacaine Single Injection Femoral Nerve Block for Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. J Pain Res. 2022 Jul 14;15:1949-1958. doi: 10.2147/JPR.S370589. eCollection 2022.

    PubMed 35860416
  • Ayoo K, Mikhaeil J, Huang A, Wasowicz M. The opioid crisis in North America: facts and future lessons for Europe. Anaesthesiol Intensive Ther. 2020;52(2):139-147. doi: 10.5114/ait.2020.94756.

    PubMed 32419434
  • Costa V, Gianlorenco AC, Andrade MF, Camargo L, Menacho M, Arias Avila M, Pacheco-Barrios K, Choi H, Song JJ, Fregni F. Transcutaneous vagus nerve stimulation effects on chronic pain: systematic review and meta-analysis. Pain Rep. 2024 Aug 7;9(5):e1171. doi: 10.1097/PR9.0000000000001171. eCollection 2024 Oct.

    PubMed 39131814
  • Straube A, Eren O. tVNS in the management of headache and pain. Auton Neurosci. 2021 Dec;236:102875. doi: 10.1016/j.autneu.2021.102875. Epub 2021 Aug 31.

    PubMed 34500261
  • Pacheco-Barrios K, Gianlorenco AC, Camargo L, Andrade MF, Choi H, Song JJ, Fregni F. Transauricular Vagus Nerve Stimulation (taVNS) enhances Conditioned Pain Modulation (CPM) in healthy subjects: A randomized controlled trial. Brain Stimul. 2024 Mar-Apr;17(2):346-348. doi: 10.1016/j.brs.2024.03.006. Epub 2024 Mar 5. No abstract available.

    PubMed 38453004
  • Ramaswamy S, Wodehouse T. Conditioned pain modulation-A comprehensive review. Neurophysiol Clin. 2021 Jun;51(3):197-208. doi: 10.1016/j.neucli.2020.11.002. Epub 2020 Dec 14.

    PubMed 33334645
  • Kaniusas E, Kampusch S, Tittgemeyer M, Panetsos F, Gines RF, Papa M, Kiss A, Podesser B, Cassara AM, Tanghe E, Samoudi AM, Tarnaud T, Joseph W, Marozas V, Lukosevicius A, Istuk N, Sarolic A, Lechner S, Klonowski W, Varoneckas G, Szeles JC. Current Directions in the Auricular Vagus Nerve Stimulation I - A Physiological Perspective. Front Neurosci. 2019 Aug 9;13:854. doi: 10.3389/fnins.2019.00854. eCollection 2019.

    PubMed 31447643
  • Chen M, Yu L, Ouyang F, Liu Q, Wang Z, Wang S, Zhou L, Jiang H, Zhou S. The right side or left side of noninvasive transcutaneous vagus nerve stimulation: Based on conventional wisdom or scientific evidence? Int J Cardiol. 2015;187:44-5. doi: 10.1016/j.ijcard.2015.03.351. Epub 2015 Mar 23. No abstract available.

    PubMed 25828310
  • Wang Y, Li SY, Wang D, Wu MZ, He JK, Zhang JL, Zhao B, Hou LW, Wang JY, Wang L, Wang YF, Zhang Y, Zhang ZX, Rong PJ. Transcutaneous Auricular Vagus Nerve Stimulation: From Concept to Application. Neurosci Bull. 2021 Jun;37(6):853-862. doi: 10.1007/s12264-020-00619-y. Epub 2020 Dec 23.

    PubMed 33355897
  • Gentile F, Orlando G, Montuoro S, Ferrari Chen YF, Macefield V, Passino C, Giannoni A, Emdin M. Treating heart failure by targeting the vagus nerve. Heart Fail Rev. 2024 Nov;29(6):1201-1215. doi: 10.1007/s10741-024-10430-w. Epub 2024 Aug 9.

    PubMed 39117958
  • Ben-Menachem E, Revesz D, Simon BJ, Silberstein S. Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Eur J Neurol. 2015 Sep;22(9):1260-8. doi: 10.1111/ene.12629. Epub 2015 Jan 23.

    PubMed 25614179
  • Nicholson WC, Kempf MC, Moneyham L, Vance DE. The potential role of vagus-nerve stimulation in the treatment of HIV-associated depression: a review of literature. Neuropsychiatr Dis Treat. 2017 Jun 28;13:1677-1689. doi: 10.2147/NDT.S136065. eCollection 2017.

    PubMed 28721049
  • Bonaz B. Enteric neuropathy and the vagus nerve: Therapeutic implications. Neurogastroenterol Motil. 2025 Aug;37(8):e14842. doi: 10.1111/nmo.14842. Epub 2024 Jun 14.

    PubMed 38873822

Questions about this trial

What is this clinical trial studying?

A study testing Transauricular Vagus Nerve Stimulation in people with Postoperative Pain, Acute and VATS, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xu Tao (0086-13145216639, xutao20010416@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Relief Rate (time frame: First postoperative day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06912399, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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