Effects of taVNS on Postoperative Pain in Complex Spinal 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: transauricular auricular vagus nerve stimulation, transauricular auricular vagus nerve stimulation.
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Postoperative Pain in Orthopaedics, Postoperative Pain Management. Basic parameters: from 18 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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Official title
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Pain in Patients Undergoing Complex Spinal Surgery: a Randomized Controlled Trial
Overview
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.
Interventions
- Device transauricular auricular vagus nerve stimulation
Patients will receive five taVNS sessions, with each session lasting 60 minutes. - Device transauricular auricular vagus nerve stimulation
Patients will receive five sham taVNS sessions, with each session lasting 60 minutes.
Primary outcome measures
- Opioid consumption within 72 hours postoperatively [Time frame: Within 72 hours postoperatively]
Secondary outcome measures (9)
- 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]
Eligibility criteria
Inclusion criteria
- Patients undergoing elective general anesthesia for complex spinal surgeries
- Age ≥ 18 years
- ASA classification I-III
Exclusion criteria
- 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
- Pregnant or lactating women
- Expected reoperation during hospitalization
- Expected to be transferred to the ICU after surgery
- Participation in other concurrent clinical trials
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
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07330973 · 2025-1950