Postoperative PaintaVNS-cSSPainNCT07330973
Effects of taVNS on Postoperative Pain in Complex Spinal Surgery
A study testing transauricular auricular vagus nerve stimulation in people with Postoperative Pain and Postoperative Pain in Orthopaedics, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive, novel neuromodulation technique. Previous studies have demonstrated its safety and efficacy in chronic pain, mental disorders, and other diseases, but evidence regarding its use in acute postoperative pain remains limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Postoperative Pain in Orthopaedics, Postoperative Pain Management
- What is being tested?
- transauricular auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 24 Dec 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective general anesthesia for complex spinal surgeries
- Age ≥ 18 years
- ASA classification I-III
Who cannot join
- Ulceration or infection of the auricle skin
- Bradycardia (heart rate of < 60 beats/min） or third-degree atrioventricular block
- Implanted cardiac pacemaker or other electronic devices
- Mental disorders or long-term use of psychotropic medications
- Severe hepatic and renal insufficiency
- Unable to understand the content of the scale assessment or unable to cooperate with the scale assessment
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- Pregnant or lactating women
- Expected reoperation during hospitalization
- Expected to be transferred to the ICU after surgery
- Participation in other concurrent clinical trials
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Pain in Patients Undergoing Complex Spinal Surgery: a Randomized Controlled Trial
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive, novel neuromodulation technique. Previous studies have demonstrated its safety and efficacy in chronic pain, mental disorders, and other diseases, but evidence regarding its use in acute postoperative pain remains limited. This project aims to explore the efficacy and safety of taVNS in managing acute pain after complex spinal surgery. This is a single-center, double-blind, randomized controlled clinical trial, planning to recruit 98 patients scheduled to undergo complex spinal surgery at the Second Affiliated Hospital of Zhejiang University School of Medicine. Participants will be randomly assigned to either the experimental group (taVNS stimulation) or the control group (sham stimulation). The experimental group will receive five stimulation sessions, each lasting one hour, from one day before surgery to three days after surgery. The primary outcome was opioid consumption within 72 hours postoperatively. Secondary outcomes included the maximum, minimum, and mean NRS on postoperative days 1, 2, and 3; NRS before and after each taVNS stimulation; time to first PCIA compression and number of PCA sessions within 3 days postoperatively; Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), and Quality of Recovery Scale (QoR15) on postoperative day 3; time to first flatus, and first bowel movement; and the incidence of chronic pain, HADS, PSQI, and QoR15 at 3 months postoperatively.
- Being tested
- transauricular auricular vagus nerve stimulation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transauricular auricular vagus nerve stimulationDevice
Patients will receive five taVNS sessions, with each session lasting 60 minutes.
transauricular auricular vagus nerve stimulationDevice
Patients will receive five sham taVNS sessions, with each session lasting 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| taVNS group | Active comparator | Paticipants in this arm will undergo a 60 minutes intervention of taVNS from one day before surgery to three days after surgery. Receives: Device: transauricular auricular vagus nerve stimulation |
| sham group | Sham comparator | Paticipants in this arm will undergo a 60 minutes sham stimulation from one day before surgery to three days after surgery. Receives: Device: transauricular auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption within 72 hours postoperatively
Researchers will record the dosage of opioids used by participants within 72 hours after surgery and convert it into morphine equivalents.
Measured: Within 72 hours postoperatively
Secondary outcomes (9)
Pain score
Maximum, minimum, and mean NRS on postoperative days 1, 2, and 3, and NRS before and after taVNS stimulation.
Measured: within 72 hours postoperatively
Use of PCIA
Including the first compression time of PCA and times of PCA within 72 hours postoperatively
Measured: Within 72 hours postoperatively
Hospital Anxiety and Depression Scale (HADS) within 3 months postoperatively
Assessed by HADS within 3 months postoperatively
Measured: on the 3 months
Pittsburgh Sleep Quality Index (PSQI) within 3 months postoperatively
assessed by PSQI within 3 months postoperatively
Measured: on the 3 months
Quality of Recovery Scale (QoR15) within 3 months postoperatively
Assessed by QoR15 within 3 months postoperatively
Measured: on the 3 months
Incidence of chronic pain
Assessed by NRS at 3 months postoperatively
Measured: at 3 months postoperatively
Functional recovery indicators
Including time to first flatus and time to first bowel movement
Measured: up to 2 weeks
Length of hospital stay
Measured: up to 1 month
Adverse events
Measured: on the 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start24 Dec 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yu lina, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330973
- Sponsor's protocol ID
- 2025-1950
- Acronym
- taVNS-cSSPain
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Pain in Patients Undergoing Complex Spinal Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07330973
- Acronym / sponsor ID
- taVNS-cSSPain / 2025-1950
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 24 Dec 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 9 Jan 2026 (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.
Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive, novel neuromodulation technique. Previous studies have demonstrated its safety and efficacy in chronic pain, mental disorders, and other diseases, but evidence regarding its use in acute postoperative pain remains limited. This project aims to explore the efficacy and safety of taVNS in managing acute pain after complex spinal surgery. This is a single-center, double-blind, randomized controlled clinical trial, planning to recruit 98 patients scheduled to undergo complex spinal surgery at the Second Affiliated Hospital of Zhejiang University School of Medicine. Participants will be randomly assigned to either the experimental group (taVNS stimulation) or the control group (sham stimulation). The experimental group will receive five stimulation sessions, each lasting one hour, from one day before surgery to three days after surgery. The primary outcome was opioid consumption within 72 hours postoperatively. Secondary outcomes included the maximum, minimum, and mean NRS on postoperative days 1, 2, and 3; NRS before and after each taVNS stimulation; time to first PCIA compression and number of PCA sessions within 3 days postoperatively; Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), and Quality of Recovery Scale (QoR15) on postoperative day 3; time to first flatus, and first bowel movement; and the incidence of chronic pain, HADS, PSQI, and QoR15 at 3 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS group | Active comparator | Device: transauricular auricular vagus nerve stimulationPaticipants in this arm will undergo a 60 minutes intervention of taVNS from one day before surgery to three days after surgery. |
| sham group | Sham comparator | Device: transauricular auricular vagus nerve stimulationPaticipants in this arm will undergo a 60 minutes sham stimulation from one day before surgery to three days after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective general anesthesia for complex spinal surgeries
- Age ≥ 18 years
- ASA classification I-III
Key exclusion criteria (10 listed)
- Ulceration or infection of the auricle skin
- Bradycardia (heart rate of < 60 beats/min） or third-degree atrioventricular block
- Implanted cardiac pacemaker or other electronic devices
- Mental disorders or long-term use of psychotropic medications
- Severe hepatic and renal insufficiency
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 |
|---|---|---|
| transauricular auricular vagus nerve stimulationPatients will receive five taVNS sessions, with each session lasting 60 minutes. | Device | taVNS group |
| transauricular auricular vagus nerve stimulationPatients will receive five sham taVNS sessions, with each session lasting 60 minutes. | Device | sham group |
Primary outcome
Opioid consumption within 72 hours postoperatively
Time frame: Within 72 hours postoperatively
Researchers will record the dosage of opioids used by participants within 72 hours after surgery and convert it into morphine equivalents.
9 secondary outcomes
Pain score
Time frame: within 72 hours postoperatively
Use of PCIA
Time frame: Within 72 hours postoperatively
Hospital Anxiety and Depression Scale (HADS) within 3 months postoperatively
Time frame: on the 3 months
Pittsburgh Sleep Quality Index (PSQI) within 3 months postoperatively
Time frame: on the 3 months
Quality of Recovery Scale (QoR15) within 3 months postoperatively
Time frame: on the 3 months
Incidence of chronic pain
Time frame: at 3 months postoperatively
Functional recovery indicators
Time frame: up to 2 weeks
Length of hospital stay
Time frame: up to 1 month
Adverse events
Time frame: on the 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing transauricular auricular vagus nerve stimulation in people with Postoperative Pain and Postoperative Pain in Orthopaedics, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lina Yu, M.D (8613958033387, zryulina@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption within 72 hours postoperatively (time frame: Within 72 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2026.