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

NCT07260266 | Not Yet Recruiting DMC

• 1 other identifier: 2025-LP-778
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• Total consumption of opioids

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

  within 24 hours postoperatively.

Secondary Outcomes (4)

• sleep quality score

  Postoperative first-night

• Quality of Recovery Score

  24 Hours Post-Operatively

• Adverse events associated with taVNS

  24 Hours Postoperatively

• The incidence of opioid-related complications

  within 24 hours post-surgery

Study Arms (2)

transcutaneous vagus nerve stimulation(taVNS)

ACTIVE COMPARATOR

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 ear 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 20 Hz, pulse width 200 μs. Each treatment session lasted for 30 minutes.

Device: Transcutaneous auricular vagus nerve stimulation

Sham-stimulation

PLACEBO COMPARATOR

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

Device: Sham Transcutaneous auricular vagus nerve stimulation

Interventions

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.

transcutaneous vagus nerve stimulation(taVNS)

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.

Sham-stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Affiliated Hospital of Jiaxing University: lead

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mingzi An

CONTACT

18035193080; anmingzizi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 3, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL