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.
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
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;
Parallel
Transcutaneous auricular vagus nerve stimulation
DevicePatients 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
DeviceThe 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.
Total consumption of opioids
Total consumption of opioids (morphine equivalent) within 24 hours postoperatively.
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.
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.
Adverse events associated with taVNS
Adverse events associated with taVNS (local skin irritation, dizziness, tinnitus, etc.);
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.
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