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

NCT06912399 | Not Yet Recruiting DMC

• 1 other identifier: K7040
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Pain, Acute; VATS

Keywords

TaVNS; Postopearvie pain; VATS

Outcome Measures

Primary Outcomes (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

  First postoperative day

Secondary Outcomes (7)

• The proportion of patients with inadequate analgesia within three days after intervention

  Within three days after the intervention

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

  First postoperative day

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

  First to the third postoperative day

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

  First to the third postoperative day

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

  First to the third postoperative day

Study Arms (2)

taVNS group.

EXPERIMENTAL

Paticipants in this arm will undergo a 2-hour intervention of taVNS on the first postoperative day.

Device: Transauricular Vagus Nerve Stimulation

sham-taVNS group.

SHAM COMPARATOR

Paticipants in this arm will undergo a 2-hour sham-intervention of taVNS on the first postoperative day.

Device: Sham Transauricular Vagus Nerve stimulation

Interventions

Transauricular Vagus Nerve Stimulation DEVICE

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.

Also known as: taVNS

taVNS group.

Sham Transauricular Vagus Nerve stimulation DEVICE

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

Also known as: Sham-taVNS

sham-taVNS group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Patient request;
• Severe perioperative complications and adverse events;
• Severe intervention-related adverse events.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Related Publications (14)

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

  PMID: 18456219 BACKGROUND

• 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.

  PMID: 35860416 BACKGROUND

• 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.

  PMID: 32419434 BACKGROUND

• 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.

  PMID: 39131814 BACKGROUND

• 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.

  PMID: 34500261 BACKGROUND

• 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.

  PMID: 38453004 BACKGROUND

• 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.

  PMID: 33334645 BACKGROUND

• 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.

  PMID: 31447643 BACKGROUND

• 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.

  PMID: 25828310 BACKGROUND

• 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.

  PMID: 33355897 BACKGROUND

• 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.

  PMID: 39117958 BACKGROUND

• 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.

  PMID: 25614179 BACKGROUND

• 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.

  PMID: 28721049 BACKGROUND

• 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.

  PMID: 38873822 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Xu Tao

CONTACT

0086-13145216639; xutao20010416@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 4, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)