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This study aims to design a prospective, double-blind, randomized controlled trial to compare the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on postoperative visceral pain in patients undergoing major abdominal surgery. Participants will be randomly assigned to receive either taVNS or sham stimulation. The total consumption of opioids and other analgesics within 24 hours post-surgery in the AICU will be recorded, along with follow-up assessments of pain scores and quality of recovery scores (Qor-15) at 24 hours postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transcutaneous vagus nerve stimulation(taVNS) | Active Comparator | Patients received taVNS treatment immediately upon entering the AICU, with sessions occurring every 2 hours. A specialized taVNS stimulator device was used, and the left ear was cleaned with an alcohol swab or wet tissue before inserting an earplug with electrode contacts into the left ear, ensuring a snug fit. A second earplug was inserted into the right ear. The stimulation parameters were set as follows: continuous wave, frequency 20 Hz, pulse width 200 μs. Each treatment session lasted for 30 minutes. |
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| Sham-stimulation | Placebo Comparator | The treatment protocol was identical to that of the taVNS group. Electrodes were placed on the left auricle. After the device was activated, it either did not deliver any current or only emitted a brief sub-threshold current to simulate the sensation of device activation, without producing continuous neural stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous auricular vagus nerve stimulation | Device | Patients received taVNS treatment immediately upon entering the AICU, with sessions occurring every 2 hours. A specialized taVNS stimulator device was used, and the left auricle was cleaned with an alcohol swab or wet tissue before inserting an earplug with electrode contacts into the left ear, ensuring a snug fit. A second earplug was inserted into the right ear. The stimulation parameters were set as follows: continuous wave, frequency of 20 Hz, and pulse width of 200 μs. Each treatment session lasted for 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Total consumption of opioids | Total consumption of opioids (morphine equivalent) within 24 hours postoperatively. | within 24 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| sleep quality score | Postoperative first-night sleep quality score (Richards-Campbell Sleep Questionnaire, RCSQ); the score ranges from 0 to 150, with higher scores indicating better sleep quality. | Postoperative first-night |
| Quality of Recovery Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingzi An | Contact | 18035193080 | anmingzizi@163.com |
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|
| Sham Transcutaneous auricular vagus nerve stimulation | Device | The treatment protocol was identical to that of the taVNS group. Electrodes were placed on the left auricle. After the device was turned on, it either did not output any current or only delivered a brief sub-threshold current to simulate the sensation of the device being activated, without producing continuous neural stimulation. |
|
Quality of Recovery Score (QoR-15) at 24 Hours Post-Operatively;The score ranges from 0 to 150 points, with higher scores indicating better postoperative recovery quality. |
| 24 Hours Post-Operatively |
| Adverse events associated with taVNS | Adverse events associated with taVNS (local skin irritation, dizziness, tinnitus, etc.); | 24 Hours Postoperatively |
| The incidence of opioid-related complications | The incidence of opioid-related complications (such as respiratory depression, nausea and vomiting, and intestinal paralysis) within 24 hours post-surgery. | within 24 hours post-surgery |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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