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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transauricular auricular vagus nerve stimulation | Device | Patients will receive five taVNS sessions, with each session lasting 60 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Maximum, minimum, and mean NRS on postoperative days 1, 2, and 3, and NRS before and after taVNS stimulation. | within 72 hours postoperatively |
| Use of PCIA | Including the first compression time of PCA and times of PCA within 72 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lina Yu, M.D | Contact | 8613958033387 | zryulina@zju.edu.cn |
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| transauricular auricular vagus nerve stimulation | Device | Patients will receive five sham taVNS sessions, with each session lasting 60 minutes. |
|
| Within 72 hours postoperatively |
| Hospital Anxiety and Depression Scale (HADS) within 3 months postoperatively | Assessed by HADS within 3 months postoperatively | on the 3 months |
| Pittsburgh Sleep Quality Index (PSQI) within 3 months postoperatively | assessed by PSQI within 3 months postoperatively | on the 3 months |
| Quality of Recovery Scale (QoR15) within 3 months postoperatively | Assessed by QoR15 within 3 months postoperatively | on the 3 months |
| Incidence of chronic pain | Assessed by NRS at 3 months postoperatively | at 3 months postoperatively |
| Functional recovery indicators | Including time to first flatus and time to first bowel movement | up to 2 weeks |
| Length of hospital stay | up to 1 month |
| Adverse events | on the 3 months |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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