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

N/ANot Yet RecruitingNCT07260266

Affiliated Hospital of Jiaxing University108 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

108

Conditions

Pain Management

Interventions

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.

Sham Transcutaneous auricular vagus nerve stimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

Total consumption of opioids

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

Time frame: within 24 hours postoperatively.

Secondary Outcomes

sleep quality score

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.

Time frame: Postoperative first-night

Quality of Recovery Score

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.

Time frame: 24 Hours Post-Operatively

Adverse events associated with taVNS

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

Time frame: 24 Hours Postoperatively

The incidence of opioid-related complications

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

Time frame: within 24 hours post-surgery