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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| taVNS group. | Experimental | Paticipants in this arm will undergo a 2-hour intervention of taVNS on the first postoperative day. |
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| sham-taVNS group. | Sham Comparator | Paticipants in this arm will undergo a 2-hour sham-intervention of taVNS on the first postoperative day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within three days after the intervention |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawl Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Tao | Contact | 0086-13145216639 | xutao20010416@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18456219 | Background | Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007. | |
| 35860416 | 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. |
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Considering patients' privacy and the measures for protecting participants, we do not plan to disclose patients' personal data.
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| 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. |
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| 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 | 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. | First to the third postoperative day |
| The difference in RCSQ scores on the night of surgery and the night after intervention | First to second postoperative day |
| 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. | Three months after surgery |
| 32419434 | 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. |
| 39131814 | 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. |
| 34500261 | 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. |
| 38453004 | 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. |
| 33334645 | 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. |
| 31447643 | 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. |
| 25828310 | 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. |
| 33355897 | 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. |
| 39117958 | 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. |
| 25614179 | 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. |
| 28721049 | 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. |
| 38873822 | 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. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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