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NCT Number: NCT07260266

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Opioid Consumption in Patients Undergoing Major Abdominal Surgery

This study aims to design a prospective, double-blind, randomized controlled trial to compare the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on postoperative visceral pain in patients undergoing major abdominal surgery. Participants will be randomly assigned to receive either taVNS or sham stimulation. The total consumption of opioids and other analgesics within 24 hours post-surgery in the AICU will be recorded, along with follow-up assessments of pain scores and quality of recovery scores (Qor-15) at 24 hours postoperatively.

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Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 85 years, regardless of gender
  • ASA physical status classification I-III
  • Scheduled for elective major abdominal surgery under general anesthesia, with postoperative admission to the AICU for monitoring
  • Anticipated duration of stay in the AICU is approximately 24 hours

Exclusion criteria

  • History of vagus nerve-related diseases (such as vasovagal syncope);
  • Severe arrhythmias or implanted electronic devices such as pacemakers;
  • Skin lesions, infections, or deformities at the site of external ear stimulation;
  • Long-term preoperative use of opioid medications or sedatives;
  • Allergy to study-related medications;

Treatment and study plan

Transcutaneous Auricular Vagus Nerve Stimulation

Device

Patients received taVNS treatment immediately upon entering the AICU, with sessions occurring every 2 hours. A specialized taVNS stimulator device was used, and the left auricle was cleaned with an alcohol swab or wet tissue before inserting an earplug with electrode contacts into the left ear, ensuring a snug fit. A second earplug was inserted into the right ear. The stimulation parameters were set as follows: continuous wave, frequency of 20 Hz, and pulse width of 200 μs. Each treatment session lasted for 30 minutes.

Sham transcutaneous auricular vagus nerve stimulation

Device

The treatment protocol was identical to that of the taVNS group. Electrodes were placed on the left auricle. After the device was turned on, it either did not output any current or only delivered a brief sub-threshold current to simulate the sensation of the device being activated, without producing continuous neural stimulation.

Primary outcomes

  1. Total consumption of opioids

    Time frame: within 24 hours postoperatively.

    Total consumption of opioids (morphine equivalent) within 24 hours postoperatively.

Secondary outcomes

  1. sleep quality score

    Time frame: Postoperative first-night

    Postoperative first-night sleep quality score (Richards-Campbell Sleep Questionnaire, RCSQ); the score ranges from 0 to 150, with higher scores indicating better sleep quality.

  2. Quality of Recovery Score

    Time frame: 24 Hours Post-Operatively

    Quality of Recovery Score (QoR-15) at 24 Hours Post-Operatively;The score ranges from 0 to 150 points, with higher scores indicating better postoperative recovery quality.

  3. Adverse events associated with taVNS

    Time frame: 24 Hours Postoperatively

    Adverse events associated with taVNS (local skin irritation, dizziness, tinnitus, etc.);

  4. The incidence of opioid-related complications

    Time frame: within 24 hours post-surgery

    The incidence of opioid-related complications (such as respiratory depression, nausea and vomiting, and intestinal paralysis) within 24 hours post-surgery.

Study contacts

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

Mingzi An

CONTACT

[email protected]

18035193080

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Jiaxing University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2025
Registry last updated
Dec 16, 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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