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

Not Applicable

Not yet recruiting

• Conditions: Postoperative Pain, Acute; VATS

• Registration Number: NCT06912399
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study Start: 2025-03-25
• Study First Submitted QC: 2025-03-30
• Last Update Submitted: 2025-03-30
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 116

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.

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;
2. Surgery cancellation or change in surgical method resulting in failure to meet inclusion criteria;
3. Severe perioperative complications and adverse events;
4. Severe intervention-related adverse events.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Relief Rate	First postoperative day	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

Secondary Outcome Measures

Name	Time	Method
The proportion of patients with inadequate analgesia within three days after intervention	Within three days after the 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.
The difference in VAS scores immediately before and after the intervention on the first postoperative day	First 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 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 specifics and frequency of additional analgesic measures taken by patients from the first to the third postoperative day after intervention	First to the third postoperative day	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.
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	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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China