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NOT YET RECRUITING
NCT06912399
NA

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2025-03-25

Completion Date

2026-12-30

Last Updated

2025-04-04

Healthy Volunteers

No

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 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.

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China