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Completed

NCT Number: NCT06763913

taVNS Reduces Postoperative Pain and Complications in Patients With Gastric and Intestinal Tumors

Postoperative acute pain control in patients with gastrointestinal tumors is not satisfactory, and surgical complications including gastrointestinal dysfunction, gastrointestinal fistula, abdominal and gastrointestinal hemorrhage, peritonitis and abscess, are still important factors affecting surgical outcomes, postoperative recovery, hospital stay, and even perioperative mortality. The application of taVNS during the perioperative period can enhance or preserve vagal nerve function, which may protect important organ functions through multiple pathways such as alleviating pain and inflammatory responses caused by surgical trauma, improving gastrointestinal function, enhancing cardiovascular regulation, reducing postoperative nausea and vomiting, and accelerating postoperative recovery, thereby reducing postoperative complications and mortality.

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Key information

Conditions

taVNS Complications Gastrointestinal Tumor Surgery Visual Analogue Scale

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second affiliated Hospital School of Medicine

Hangzhou, Zhejiang, 310000, China

About this study

Subjects who met the inclusion criteria were enrolled in the clinical trial and received 2 interventions at the following times: the day before surgery, and the afternoon of the 1st day postoperatively (15:00-17:00), a total of 2 times. The intervention implementers used vagus nerve stimulation equipment to place electrodes in the tragus area of the outer ear of the subjects in the experimental group (taVNS group). The control group (sham stimulation group) was set to have a pulse width of 200 μs, a frequency of 1 Hz, and an initial current of 10 mA, which was gradually increased to the pain tolerance threshold of the subject, capped at 50 mA，last for one hour. The VAS scores before and after stimulation for 10 minutes were recorded.

  • ECG monitoring: Both groups were monitored with a dynamic ECG monitor during the intervention period, starting 10 minutes before stimulation and ending 10 minutes after stimulation. The SDNN (Standard Deviation of NN intervals) of the sinus rhythm was measured before and after stimulation for 10 minutes. A uniform standard was used for anesthesia induction and maintenance during surgery, and all patients used the same patient-controlled intravenous analgesia (PCIA) plan.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age 18-80 years, BMI 18-30 kg/m², ASA Ⅱ-Ⅲ, elective laparoscopic gastric or intestinal tumor surgery, expected surgical duration ≥2 hours, patient understands study content and signs informed consent form.

Exclusion criteria

Kidney replacement therapy, treatment for arrhythmias requiring treatment, dementia, severe bradycardia, orthostatic tachycardia syndrome, neuro-muscular disorders, auricular dermatitis, planned post-operative transfer to ICU

Treatment and study plan

taVNS

Device

Set the pulse width to 200 microseconds, frequency to 30 Hz, and start the current at 10 mA. Gradually increase the current until the patient reaches their pain tolerance threshold, and cap it at 50 mA，last for one hour.During the intervention, dynamic ECG monitoring was conducted using an ECG monitor, starting 10 minutes before the stimulation and ending 10 minutes after the stimulation.

Sham taVNS

Device

Set the pulse width to 200 microseconds, frequency to 1 Hz, and start the current at 10 mA. Gradually increase the current until the patient reaches their pain tolerance threshold, and cap it at 50 mA，last for one hour.During the intervention, dynamic ECG monitoring was conducted using an ECG monitor, starting 10 minutes before the stimulation and ending 10 minutes after the stimulation.

Primary outcomes

  1. Difference in VAS Score on Postoperative Day 1

    Time frame: before and after each stimulus for 10 minutes

    Difference in VAS Score on Postoperative Day 1

Secondary outcomes

  1. The QoR-15 scale scores on the 1st and 3rd days after surgery

    Time frame: 1 day before the operation and the third day after the operation

    The QoR-15 scale scores on the 1st and 3rd days after surgery

  2. Postoperative Complication Rate

    Time frame: 1 day before being discharged from the hospital

    Postoperative in-hospital complication rate

  3. The time of the first postoperative anal exhaust

    Time frame: On the third day after the operation

    The time of the first postoperative anal exhaust

  4. The effective number of pain relief pump presses

    Time frame: One day before being discharged from the hospital

    The effective number of pain relief pump presses

  5. Postoperative Salvage Analgesic Consumption of Opioid Equivalents

    Time frame: One day before being discharged from the hospital

    Postoperative Salvage Analgesic Consumption of Opioid Equivalents

  6. Length of hospital stay

    Time frame: One day before being discharged from the hospital

    Length of hospital stay

  7. Standard Deviation of NN intervals

    Time frame: 10 minutes before and after each stimulus

    10 minutes before and after each stimulus

  8. Root Mean Square of the Successive Differences

    Time frame: 10 minutes before and after each stimulus

    10 minutes before and after each stimulus

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

taVNS Reduces Postoperative Pain and Complications in Patients With Gastric and Intestinal Tumors: A Randomized, Double-Blind, Parallel-Controlled Trial

Acronym: taVNS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2025
Registry last updated
Aug 27, 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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