Effects of taVNS on Postoperative Pain in Complex Spinal Surgery

NCT ID: NCT07330973

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-24
• Study Completion Date: 2026-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

taVNS group

Paticipants in this arm will undergo a 60 minutes intervention of taVNS from one day before surgery to three days after surgery.

Group Type: ACTIVE_COMPARATOR

transauricular auricular vagus nerve stimulation

Intervention Type: DEVICE

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

sham group

Paticipants in this arm will undergo a 60 minutes sham stimulation from one day before surgery to three days after surgery.

Group Type: SHAM_COMPARATOR

transauricular auricular vagus nerve stimulation

Intervention Type: DEVICE

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

Interventions

transauricular auricular vagus nerve stimulation

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

Intervention Type: DEVICE

transauricular auricular vagus nerve stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients undergoing elective general anesthesia for complex spinal surgeries

2. Age ≥ 18 years

3. ASA classification I-III

Exclusion Criteria

1. Ulceration or infection of the auricle skin

2. Bradycardia (heart rate of < 60 beats/min） or third-degree atrioventricular block

3. Implanted cardiac pacemaker or other electronic devices

4. Mental disorders or long-term use of psychotropic medications

5. Severe hepatic and renal insufficiency

6. Unable to understand the content of the scale assessment or unable to cooperate with the scale assessment

7. Pregnant or lactating women

8. Expected reoperation during hospitalization

9. Expected to be transferred to the ICU after surgery

10. Participation in other concurrent clinical trials

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

yu lina

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Lina Yu, M.D

Role: CONTACT

zryulina@zju.edu.cn

8613958033387

Other Identifiers

2025-1950

Identifier Type: -

Identifier Source: org_study_id