Clinical trial NCT06788561: Effect of Transcutaneous Vagus Nerve Stimulation for Pain Control After Cesarean Delivery
Official title: Effect of Non-invasive Transcutaneous Vagus Nerve Stimulation for Pain Control After Cesarean Delivery - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain, Acute
Keywords: Transcutaneous auricular vagus nerve stimulation (taVNS)
Auricular acupoint
Cesarean section
Postoperative pain
Inflammatory response
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric Rating Scale (NRS-11) pain score during movement
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: the proportion of patients with NRS pain score > 6
timeFrame: 24 hours postoperatively
measure: Epinephrine
timeFrame: 48 hours postoperatively
measure: C-reactive protein (CRP)
timeFrame: 48 hours postoperatively
measure: NFκB
timeFrame: 48 hours postoperatively
measure: aEP
timeFrame: 48 hours postoperatively
measure: Postoperative adverse reactions
timeFrame: From date of randomization until the date of discharge, assessed up to 7 days
measure: Postoperative severe complications
timeFrame: From date of randomization until the date of discharge, assessed up to 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing tongren Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tongren Hospital
name: Guyan Wang
role: STUDY_DIRECTOR
References: