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

March 30, 2025 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
        • Contact:
          • Li Jiayue
          • Phone Number: 0086-010-69156874

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: taVNS group.
Paticipants in this arm will undergo a 2-hour intervention of taVNS on the first postoperative day.
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.
Other Names:
  • taVNS
Sham Comparator: sham-taVNS group.
Paticipants in this arm will undergo a 2-hour sham-intervention of taVNS on the first postoperative day.
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.
Other Names:
  • Sham-taVNS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
First postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within three days after the intervention
The difference in VAS scores immediately before and after the intervention on the first postoperative day
Time Frame: First postoperative day
First postoperative day
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
First to the third postoperative day
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
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
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.
First to the third postoperative day
The difference in RCSQ scores on the night of surgery and the night after intervention
Time Frame: First to second postoperative day
First to second postoperative day
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.
Three months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 25, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 30, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

March 30, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K7040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Considering patients' privacy and the measures for protecting participants, we do not plan to disclose patients' personal data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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