Postoperative Pain, Postoperative Pain in Orthopaedics, Postoperative Pain Management
Conditions
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.
Interventions
Patients will receive five taVNS sessions, with each session lasting 60 minutes.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption within 72 hours postoperatively | 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
| Measure | Time frame | Description |
|---|---|---|
| Use of PCIA | Within 72 hours postoperatively | Including the first compression time of PCA and times of PCA within 72 hours postoperatively |
| Hospital Anxiety and Depression Scale (HADS) within 3 months postoperatively | on the 3 months | Assessed by HADS within 3 months postoperatively |
| Pittsburgh Sleep Quality Index (PSQI) within 3 months postoperatively | on the 3 months | assessed by PSQI within 3 months postoperatively |
| Quality of Recovery Scale (QoR15) within 3 months postoperatively | on the 3 months | Assessed by QoR15 within 3 months postoperatively |
| Pain score | within 72 hours postoperatively | Maximum, minimum, and mean NRS on postoperative days 1, 2, and 3, and NRS before and after taVNS stimulation. |
| Functional recovery indicators | up to 2 weeks | Including time to first flatus and time to first bowel movement |
| Length of hospital stay | up to 1 month | — |
| Adverse events | on the 3 months | — |
| Incidence of chronic pain | at 3 months postoperatively | Assessed by NRS at 3 months postoperatively |
Contacts
Primary ContactLina Yu, M.D
Outcome results
None listed