An interventional study of Transcutaneous auricular vagus nerve stimulation and Sham Transcutaneous auricular vagus nerve stimulation in Pain Management, sponsored by Affiliated Hospital of Jiaxing University. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Affiliated Hospital of Jiaxing University · Not applicable, Interventional, and Prevention
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.
Affiliated Hospital of Jiaxing University is the lead sponsor of 17 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Total consumption of opioids
Total consumption of opioids (morphine equivalent) within 24 hours postoperatively.
Time frame: 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.
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
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Agnosia
Affiliated Hospital of Jiaxing University