Effects of taVNS on Postoperative Pain in Complex Spinal Surgery

NCT07330973 | Not Yet Recruiting

• 1 other identifier: 2025-1950
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Postoperative Pain; Postoperative Pain in Orthopaedics; Postoperative Pain Management

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 72 hours postoperatively

Secondary Outcomes (9)

• Pain score

  within 72 hours postoperatively

• Use of PCIA

  Within 72 hours postoperatively

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

  on the 3 months

• Pittsburgh Sleep Quality Index (PSQI) within 3 months postoperatively

  on the 3 months

• Quality of Recovery Scale (QoR15) within 3 months postoperatively

  on the 3 months

Study Arms (2)

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.

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.

Device: transauricular auricular vagus nerve stimulation

Interventions

transauricular auricular vagus nerve stimulation DEVICE

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

taVNS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective general anesthesia for complex spinal surgeries
• Age ≥ 18 years
• ASA classification I-III

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Lina Yu, M.D

CONTACT

8613958033387; zryulina@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 9, 2026
• Study Start: December 24, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12