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This study investigates whether non-invasive transcutaneous auricular vagus nerve stimulation can alleviate postoperative pain in patients after cesarean section, and explores its possible mechanisms of action through an exploratory study.
Post-cesarean section pain, if improperly managed, may affect the prognosis of the mother and the health of the infant. There is an urgent need to explore safer, more effective, and more direct non-pharmacological, non-invasive adjunctive interventions to alleviate the pain associated with cesarean section. Non-invasive transcutaneous auricular vagus nerve stimulation is a green neuromodulatory measure that has shown significant improvement in various types of pain and holds great potential for relieving perioperative pain. This study aims to investigate whether non-invasive transcutaneous auricular vagus nerve stimulation can alleviate postoperative pain in patients after cesarean section and to explore the possible mechanisms by which it exerts its effects, through a prospective randomized controlled clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous auricular vagus nerve stimulation (taVNS) | Experimental | Bilateral auricle area is selected, where the branches of the vagus nerve are abundantly distributed. The use of an SDZ-IIB electronic acupuncture therapy device and specially designed ear clips to stimulate both sides for 30 minutes each session. The stimulation parameters are set to sparse dense wave, with a frequency of 4 Hz/20 Hz, and the intensity is adjusted based on the patient's tolerance, gradually increasing from 0 to the highest point the patient can tolerate. A total of two stimulations are administered, the first immediately after the baby is delivered, and the second is 23.5 hours postoperative. |
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| Sham transcutaneous auricular vagus nerve stimulation (s-taVNS) | Sham Comparator | Bilateral auricular areas are selected, where the branches of the vagus nerve are abundantly distributed. An SDZ-IIB electronic acupuncture therapy device and specially designed ear clips are used to stimulate both sides. The stimulation parameters are set to sparse dense waves, with a frequency of 4 Hz/20 Hz, and the intensity is adjusted based on the patient's tolerance, gradually increasing from 0 to the highest level the patient can endure, then the device is then turned off, electric current stimulation is applied for approximately 10 seconds. The process of attaching the clip to the earlasts for 30 minutes. A total of two stimulations are administered, the first immediately after the baby is delivered, and the second 23.5 hours postoperatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transauricular Nerve Stimulation | Device | Hua Tuo brand SDZ-IIB electronic acupuncture therapy device and specially designed ear clips. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS-11) pain score during movement | Numeric Rating Scale (NRS-11), this scale is a validated tool for measuring pain intensity, with scores ranging from 0 (no pain) to 10 (the most severe pain imaginable).The higher the score, the more severe the pain. | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of patients with NRS pain score > 6 | Assess the proportion of severe pain by calculating the ratio of NRS pain scores that are greater than 6. | 24 hours postoperatively |
| Epinephrine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guyan Wang | Beijing Tongren Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing tongren Hospital, Capital Medical University | Beijing | 100730 | China |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| s-taVNS | Device | Hua Tuo brand SDZ-IIB electronic acupuncture therapy device and specially designed ear clips. |
|
Serum Epinephrine concentration.
| 48 hours postoperatively |
| C-reactive protein (CRP) | Serum CRP concentration. | 48 hours postoperatively |
| NFκB | Serum NFκB concentration. | 48 hours postoperatively |
| aEP | Serum aEP concentration | 48 hours postoperatively |
| Postoperative adverse reactions | Explore whether taVNS intervention increases postoperative adverse reactions, including dizziness, bloating, itching and so on. | From date of randomization until the date of discharge, assessed up to 7 days |
| Postoperative severe complications | Postoperative severe complications, including pulmonary complications, liver function abnormalities, heart function abnormalities, kidney function abnormalities, and SIRS (Systemic Inflammatory Response Syndrome). | From date of randomization until the date of discharge, assessed up to 7 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |