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

NCT07260266 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-12-16

No results posted yet for this study

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

Interventions

DEVICE

Transcutaneous auricular vagus nerve stimulation

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.

DEVICE

Sham Transcutaneous auricular vagus nerve stimulation

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.

Sponsors & Collaborators

  • Affiliated Hospital of Jiaxing University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-30
Completion
2027-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07260266 on ClinicalTrials.gov