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

Official title

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

Overview

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.

Interventions

• Device Transauricular Vagus Nerve Stimulation
  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 maxi
• Device Sham Transauricular Vagus Nerve stimulation
  The only thing differs with the taVNS group is that the device will automatically shut down after running for 15 seconds.

Primary outcome measures

• Pain Relief Rate [Time frame: First postoperative day]

Secondary outcome measures (7)

• The proportion of patients with inadequate analgesia within three days after intervention [Time frame: Within three days after the intervention]
• The difference in VAS scores immediately before and after the intervention on the first postoperative day [Time frame: First postoperative day]
• The incidence of opioid-related and taVNS-related side effects from the first to the third postoperative day after intervention [Time frame: 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 [Time frame: 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 [Time frame: First to the third postoperative day]
• The difference in RCSQ scores on the night of surgery and the night after intervention [Time frame: First to second postoperative day]
• The probability of patients experiencing surgery-related pain three months after surgery [Time frame: Three months after surgery]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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. e PMID 31447643

Identifiers

NCT: NCT06912399 · K7040

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗