NCT06912399

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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 maximum amount that the patients can tolerate without pain.
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.

Timeline

• Start date: 2025-03-25
• Primary completion: 2026-06-30
• Completion: 2026-12-30
• First posted: 2025-04-04
• Last updated: 2025-04-04

Locations

1 site across 1 country: China