Postoperative Pain, Acute
Conditions
Keywords
Transcutaneous auricular vagus nerve stimulation (taVNS), Auricular acupoint, Cesarean section, Postoperative pain, Inflammatory response
Brief summary
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.
Detailed description
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.
Interventions
DEVICETransauricular Nerve Stimulation
Hua Tuo brand SDZ-IIB electronic acupuncture therapy device and specially designed ear clips.
DEVICEs-taVNS
Hua Tuo brand SDZ-IIB electronic acupuncture therapy device and specially designed ear clips.
Sponsors
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Patients are classified as American Society of Anesthesiologists (ASA) physical status I to III. 2. Scheduled for elective cesarean delivery under spinal anesthesia. 3. Patients are aged between 19 to 45 years old. 4. Patients have provided written informed consent.
Exclusion criteria
1. Local skin infection occurs in the auricular area during transcutaneous auricular vagus nerve stimulation. 2. Cases where spinal anesthesia fails and general anesthesia is required. 3. Patients with conditions such as recurrent alcohol abuse, fever, convulsions, or cardiopulmonary failure. 4. Patients who have used opioid medications at least 6 months prior to surgery. 5. Patients who are unable to understand the consent form and study questionnaire, including those with cognitive impairments. 6. Patients with a history of psychiatric illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS-11) pain score during movement | 24 hours postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epinephrine | 48 hours postoperatively | Serum Epinephrine concentration. |
| C-reactive protein (CRP) | 48 hours postoperatively | Serum CRP concentration. |
| NFκB | 48 hours postoperatively | Serum NFκB concentration. |
| the proportion of patients with NRS pain score > 6 | 24 hours postoperatively | Assess the proportion of severe pain by calculating the ratio of NRS pain scores that are greater than 6. |
| Postoperative adverse reactions | From date of randomization until the date of discharge, assessed up to 7 days | Explore whether taVNS intervention increases postoperative adverse reactions, including dizziness, bloating, itching and so on. |
| Postoperative severe complications | From date of randomization until the date of discharge, assessed up to 7 days | Postoperative severe complications, including pulmonary complications, liver function abnormalities, heart function abnormalities, kidney function abnormalities, and SIRS (Systemic Inflammatory Response Syndrome). |
| aEP | 48 hours postoperatively | Serum aEP concentration |
Countries
China
Outcome results
None listed