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NCT Number: NCT07330973

Effects of taVNS on Postoperative Pain in Complex Spinal Surgery

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transauricular auricular vagus nerve stimulation

Device

Patients will receive five taVNS sessions, with each session lasting 60 minutes.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain score

    Time frame: within 72 hours postoperatively

    Maximum, minimum, and mean NRS on postoperative days 1, 2, and 3, and NRS before and after taVNS stimulation.

  2. Use of PCIA

    Time frame: Within 72 hours postoperatively

    Including the first compression time of PCA and times of PCA within 72 hours postoperatively

  3. Hospital Anxiety and Depression Scale (HADS) within 3 months postoperatively

    Time frame: on the 3 months

    Assessed by HADS within 3 months postoperatively

  4. Pittsburgh Sleep Quality Index (PSQI) within 3 months postoperatively

    Time frame: on the 3 months

    assessed by PSQI within 3 months postoperatively

  5. Quality of Recovery Scale (QoR15) within 3 months postoperatively

    Time frame: on the 3 months

    Assessed by QoR15 within 3 months postoperatively

  6. Incidence of chronic pain

    Time frame: at 3 months postoperatively

    Assessed by NRS at 3 months postoperatively

  7. Functional recovery indicators

    Time frame: up to 2 weeks

    Including time to first flatus and time to first bowel movement

  8. Length of hospital stay

    Time frame: up to 1 month

  9. Adverse events

    Time frame: on the 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Lina Yu, M.D

CONTACT

[email protected]

8613958033387

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Pain in Patients Undergoing Complex Spinal Surgery: a Randomized Controlled Trial

Acronym: taVNS-cSSPain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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