taVNStaVNSNCT06763913
taVNS Reduces Postoperative Pain and Complications in Patients With Gastric and Intestinal Tumors
A study testing taVNS in people with taVNS and Gastrointestinal Tumor Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Postoperative acute pain control in patients with gastrointestinal tumors is not satisfactory, and surgical complications including gastrointestinal dysfunction, gastrointestinal fistula, abdominal and gastrointestinal hemorrhage, peritonitis and abscess, are still important factors affecting surgical outcomes… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- taVNS, Gastrointestinal Tumor Surgery, Visual Analogue Scale
- What is being tested?
- taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years, BMI 18-30 kg/m², ASA Ⅱ-Ⅲ, elective laparoscopic gastric or intestinal tumor surgery, expected surgical duration ≥2 hours, patient understands study content and signs informed consent form.
Who cannot join
- Kidney replacement therapy, treatment for arrhythmias requiring treatment, dementia, severe bradycardia, orthostatic tachycardia syndrome, neuro-muscular disorders, auricular dermatitis, planned post-operative transfer to ICU
Trial locations and contacts
1 site in 1 country.
China1 site
Second affiliated Hospital School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: taVNS Reduces Postoperative Pain and Complications in Patients With Gastric and Intestinal Tumors: A Randomized, Double-Blind, Parallel-Controlled Trial
Postoperative acute pain control in patients with gastrointestinal tumors is not satisfactory, and surgical complications including gastrointestinal dysfunction, gastrointestinal fistula, abdominal and gastrointestinal hemorrhage, peritonitis and abscess, are still important factors affecting surgical outcomes, postoperative recovery, hospital stay, and even perioperative mortality. The application of taVNS during the perioperative period can enhance or preserve vagal nerve function, which may protect important organ functions through multiple pathways such as alleviating pain and inflammatory responses caused by surgical trauma, improving gastrointestinal function, enhancing cardiovascular regulation, reducing postoperative nausea and vomiting, and accelerating postoperative recovery, thereby reducing postoperative complications and mortality.
Read the detailed description
Subjects who met the inclusion criteria were enrolled in the clinical trial and received 2 interventions at the following times: the day before surgery, and the afternoon of the 1st day postoperatively (15:00-17:00), a total of 2 times. The intervention implementers used vagus nerve stimulation equipment to place electrodes in the tragus area of the outer ear of the subjects in the experimental group (taVNS group). The control group (sham stimulation group) was set to have a pulse width of 200 μs, a frequency of 1 Hz, and an initial current of 10 mA, which was gradually increased to the pain tolerance threshold of the subject, capped at 50 mA，last for one hour. The VAS scores before and after stimulation for 10 minutes were recorded.
- ECG monitoring: Both groups were monitored with a dynamic ECG monitor during the intervention period, starting 10 minutes before stimulation and ending 10 minutes after stimulation. The SDNN (Standard Deviation of NN intervals) of the sinus rhythm was measured before and after stimulation for 10 minutes. A uniform standard was used for anesthesia induction and maintenance during surgery, and all patients used the same patient-controlled intravenous analgesia (PCIA) plan.
- Being tested
- taVNS, sham taVNS
- Keywords
- taVNS, Perioperative period, Visual Analogue Scale, complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
Set the pulse width to 200 microseconds, frequency to 30 Hz, and start the current at 10 mA. Gradually increase the current until the patient reaches their pain tolerance threshold, and cap it at 50 mA，last for one hour.During the intervention, dynamic ECG monitoring was conducted using an ECG monitor, starting 10 minutes before the stimulation and ending 10 minutes after the stimulation.
sham taVNSDevice
Set the pulse width to 200 microseconds, frequency to 1 Hz, and start the current at 10 mA. Gradually increase the current until the patient reaches their pain tolerance threshold, and cap it at 50 mA，last for one hour.During the intervention, dynamic ECG monitoring was conducted using an ECG monitor, starting 10 minutes before the stimulation and ending 10 minutes after the stimulation.
| Study group | Role | What they receive |
|---|---|---|
| taVNS | Experimental | Set the pulse width to 200 microseconds, frequency to 30 Hz, and start the current at 10 mA. Gradually increase the current until the patient reaches their pain tolerance threshold, and cap it at 50 mA. Receives: Device: taVNS |
| sham taVNS | Sham comparator | Set the pulse width to 200 microseconds, frequency to 1 Hz, current to 10 mA and gradually increase it to the patient's pain tolerance threshold, capped at 50 mA. Receives: Device: sham taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in VAS Score on Postoperative Day 1
Difference in VAS Score on Postoperative Day 1
Measured: before and after each stimulus for 10 minutes
Secondary outcomes (8)
The QoR-15 scale scores on the 1st and 3rd days after surgery
The QoR-15 scale scores on the 1st and 3rd days after surgery
Measured: 1 day before the operation and the third day after the operation
Postoperative Complication Rate
Postoperative in-hospital complication rate
Measured: 1 day before being discharged from the hospital
The time of the first postoperative anal exhaust
The time of the first postoperative anal exhaust
Measured: On the third day after the operation
The effective number of pain relief pump presses
The effective number of pain relief pump presses
Measured: One day before being discharged from the hospital
Postoperative Salvage Analgesic Consumption of Opioid Equivalents
Postoperative Salvage Analgesic Consumption of Opioid Equivalents
Measured: One day before being discharged from the hospital
Length of hospital stay
Length of hospital stay
Measured: One day before being discharged from the hospital
Standard Deviation of NN intervals
10 minutes before and after each stimulus
Measured: 10 minutes before and after each stimulus
Root Mean Square of the Successive Differences
10 minutes before and after each stimulus
Measured: 10 minutes before and after each stimulus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Jan 2025
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for taVNSStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763913
- Sponsor's protocol ID
- 2024-1127
- Acronym
- taVNS
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yi Y, Li Y, Luo G, Fang Y, He L, Ni H, Wu H, Li M, Xia S, Wu W, Ma L, Yu L. Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Pain Relief in Patients Undergoing Elective Laparoscopic Gastrointestinal Tumor Surgery. Pain Ther. 2026 Jun;15(3):681-695. doi: 10.1007/s40122-026-00825-y. Epub 2026 Mar 13.
PubMed 41824217
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- taVNS Reduces Postoperative Pain and Complications in Patients With Gastric and Intestinal Tumors: A Randomized, Double-Blind, Parallel-Controlled Trial
- ClinicalTrials.gov ID
- NCT06763913
- Acronym / sponsor ID
- taVNS / 2024-1127
- Keywords
- taVNS, Perioperative period, Visual Analogue Scale, complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative acute pain control in patients with gastrointestinal tumors is not satisfactory, and surgical complications including gastrointestinal dysfunction, gastrointestinal fistula, abdominal and gastrointestinal hemorrhage, peritonitis and abscess, are still important factors affecting surgical outcomes, postoperative recovery, hospital stay, and even perioperative mortality. The application of taVNS during the perioperative period can enhance or preserve vagal nerve function, which may protect important organ functions through multiple pathways such as alleviating pain and inflammatory responses caused by surgical trauma, improving gastrointestinal function, enhancing cardiovascular regulation, reducing postoperative nausea and vomiting, and accelerating postoperative recovery, thereby reducing postoperative complications and mortality.
Detailed description
Subjects who met the inclusion criteria were enrolled in the clinical trial and received 2 interventions at the following times: the day before surgery, and the afternoon of the 1st day postoperatively (15:00-17:00), a total of 2 times. The intervention implementers used vagus nerve stimulation equipment to place electrodes in the tragus area of the outer ear of the subjects in the experimental group (taVNS group). The control group (sham stimulation group) was set to have a pulse width of 200 μs, a frequency of 1 Hz, and an initial current of 10 mA, which was gradually increased to the pain tolerance threshold of the subject, capped at 50 mA，last for one hour. The VAS scores before and after stimulation for 10 minutes were recorded.
- ECG monitoring: Both groups were monitored with a dynamic ECG monitor during the intervention period, starting 10 minutes before stimulation and ending 10 minutes after stimulation. The SDNN (Standard Deviation of NN intervals) of the sinus rhythm was measured before and after stimulation for 10 minutes. A uniform standard was used for anesthesia induction and maintenance during surgery, and all patients used the same patient-controlled intravenous analgesia (PCIA) plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS | Experimental | Device: taVNSSet the pulse width to 200 microseconds, frequency to 30 Hz, and start the current at 10 mA. Gradually increase the current until the patient reaches their pain tolerance threshold, and cap it at 50 mA. |
| sham taVNS | Sham comparator | Device: sham taVNSSet the pulse width to 200 microseconds, frequency to 1 Hz, current to 10 mA and gradually increase it to the patient's pain tolerance threshold, capped at 50 mA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-80 years, BMI 18-30 kg/m², ASA Ⅱ-Ⅲ, elective laparoscopic gastric or intestinal tumor surgery, expected surgical duration ≥2 hours, patient understands study content and signs informed consent form.
Key exclusion criteria (1 listed)
- Kidney replacement therapy, treatment for arrhythmias requiring treatment, dementia, severe bradycardia, orthostatic tachycardia syndrome, neuro-muscular disorders, auricular dermatitis, planned post-operative transfer to ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taVNSSet the pulse width to 200 microseconds, frequency to 30 Hz, and start the current at 10 mA. Gradually increase the current until the patient reaches their pain tolerance threshold, and cap it at 50 mA，last for one hour.During the intervention, dynamic ECG monitoring was conducted using an ECG monitor, starting 10 minutes before the stimulation and ending 10 minutes after the stimulation. | Device | taVNS |
| sham taVNSSet the pulse width to 200 microseconds, frequency to 1 Hz, and start the current at 10 mA. Gradually increase the current until the patient reaches their pain tolerance threshold, and cap it at 50 mA，last for one hour.During the intervention, dynamic ECG monitoring was conducted using an ECG monitor, starting 10 minutes before the stimulation and ending 10 minutes after the stimulation. | Device | sham taVNS |
Primary outcome
Difference in VAS Score on Postoperative Day 1
Time frame: before and after each stimulus for 10 minutes
Difference in VAS Score on Postoperative Day 1
8 secondary outcomes
The QoR-15 scale scores on the 1st and 3rd days after surgery
Time frame: 1 day before the operation and the third day after the operation
Postoperative Complication Rate
Time frame: 1 day before being discharged from the hospital
The time of the first postoperative anal exhaust
Time frame: On the third day after the operation
The effective number of pain relief pump presses
Time frame: One day before being discharged from the hospital
Postoperative Salvage Analgesic Consumption of Opioid Equivalents
Time frame: One day before being discharged from the hospital
Length of hospital stay
Time frame: One day before being discharged from the hospital
Standard Deviation of NN intervals
Time frame: 10 minutes before and after each stimulus
Root Mean Square of the Successive Differences
Time frame: 10 minutes before and after each stimulus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Derived from this study: PubMed 41824217Yi Y, Li Y, Luo G, Fang Y, He L, Ni H, Wu H, Li M, Xia S, Wu W, Ma L, Yu L. Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Pain Relief in Patients Undergoing Elective Laparoscopic Gastrointestinal Tumor Surgery. Pain Ther. 2026 Jun;15(3):681-695. doi: 10.1007/s40122-026-00825-y. Epub 2026 Mar 13.
Related trials for taVNS
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Active, not recruiting
TaVNS for Delirium
Delirium
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)
Chronic Kidney Diseases
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During the Withdrawal-Rehabilitation Period of Methamphetamine Use Disorder
Insomnia
Not yet recruiting
Effects of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Cognition, Dual-Task Performance, and Interoceptive Accuracy
Cognition, Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS in people with taVNS and Gastrointestinal Tumor Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in VAS Score on Postoperative Day 1 (time frame: before and after each stimulus for 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06763913, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.