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NCT Number: NCT06912399

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

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.

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Key information

Conditions

Postoperative Pain, Acute Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms VATS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location contact

Li Jiayue

CONTACT

0086-010-69156874

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transauricular Vagus Nerve Stimulation

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.

Other names: taVNS

Sham Transauricular Vagus Nerve stimulation

Device

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

Other names: Sham-taVNS

Primary outcomes

  1. Pain Relief Rate

    Time frame: 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 outcomes

  1. The proportion of patients with inadequate analgesia within three days after intervention

    Time frame: 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.

  2. The difference in VAS scores immediately before and after the intervention on the first postoperative day

    Time frame: First postoperative day

  3. 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

  4. 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

  5. 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 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.

  6. The difference in RCSQ scores on the night of surgery and the night after intervention

    Time frame: First to second postoperative day

  7. The probability of patients experiencing surgery-related pain three months after surgery

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xu Tao

CONTACT

[email protected]

0086-13145216639

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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