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

NCT ID: NCT06912399

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2026-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

taVNS group.

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

Group Type: EXPERIMENTAL

Transauricular Vagus Nerve Stimulation

Intervention Type: 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.

sham-taVNS group.

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

Group Type: SHAM_COMPARATOR

Sham Transauricular Vagus Nerve stimulation

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

taVNS; Sham-taVNS

Eligibility Criteria

Inclusion Criteria

1. Age 18 years or older;

2. ASA classification I-III;

3. No prior taVNS treatment;

4. Scheduled to undergo VATS (including segmentectomy and lobectomy);

5. VAS ≥ 30 mm at any time on the day of surgery;

6. Patients and their families can understand the study design and are willing to cooperate and participate in the study.

3. Severe perioperative complications and adverse events;

4. Severe intervention-related adverse events.

Exclusion Criteria

1. Psychiatric disorders or other conditions that prevent cooperation;

2. Long-term use of steroids or opioids;

3. Scheduled for bilateral VATS surgery;

4. History of thoracic surgery;

5. History of chronic pain, autoimmune diseases, or persistent infections.

Withdrawl Criteria:

1. Patient request;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Countries

China

Central Contacts

Xu Tao

Role: CONTACT

xutao20010416@163.com

0086-13145216639

Facility Contacts

Li Jiayue

Role: primary

0086-010-69156874

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Other Identifiers

K7040

Identifier Type: -

Identifier Source: org_study_id