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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Hua Tuo brand SDZ-IIB electronic acupuncture therapy device and specially designed ear clips.
Hua Tuo brand SDZ-IIB electronic acupuncture therapy device and specially designed ear clips.
Beijing tongren Hospital, Capital Medical University
Beijing, China
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.
Time frame: 24 hours postoperatively
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.
Time frame: 24 hours postoperatively
Epinephrine
Serum Epinephrine concentration.
Time frame: 48 hours postoperatively
C-reactive protein (CRP)
Serum CRP concentration.
Time frame: 48 hours postoperatively
NFκB
Serum NFκB concentration.
Time frame: 48 hours postoperatively
aEP
Serum aEP concentration
Time frame: 48 hours postoperatively
Postoperative adverse reactions
Explore whether taVNS intervention increases postoperative adverse reactions, including dizziness, bloating, itching and so on.
Time frame: 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).
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Time frame: From date of randomization until the date of discharge, assessed up to 7 days