Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Opioid Consumption in Patients Undergoing Major Abdominal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous auricular vagus nerve stimulation, Sham Transcutaneous auricular vagus nerve stimulation.
- Who it may be relevant to
- Registry conditions: Pain Management. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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 sessio - 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.
Primary outcome measures
- Total consumption of opioids [Time frame: within 24 hours postoperatively.]
Secondary outcome measures (4)
- sleep quality score [Time frame: Postoperative first-night]
- Quality of Recovery Score [Time frame: 24 Hours Post-Operatively]
- Adverse events associated with taVNS [Time frame: 24 Hours Postoperatively]
- The incidence of opioid-related complications [Time frame: within 24 hours post-surgery]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07260266 · 2025-LP-778