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Completed

NCT Number: NCT06788561

Effect of Transcutaneous Vagus Nerve Stimulation for Pain Control After Cesarean Delivery

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.

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Key information

Conditions

Postoperative Pain, Acute Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beijing tongren Hospital, Capital Medical University

Beijing, 100730, China

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients are classified as American Society of Anesthesiologists (ASA) physical status I to III.
  • Scheduled for elective cesarean delivery under spinal anesthesia.
  • Patients are aged between 19 to 45 years old.
  • Patients have provided written informed consent.

Exclusion criteria

  • Local skin infection occurs in the auricular area during transcutaneous auricular vagus nerve stimulation.
  • Cases where spinal anesthesia fails and general anesthesia is required.
  • Patients with conditions such as recurrent alcohol abuse, fever, convulsions, or cardiopulmonary failure.
  • Patients who have used opioid medications at least 6 months prior to surgery.
  • Patients who are unable to understand the consent form and study questionnaire, including those with cognitive impairments.
  • Patients with a history of psychiatric illness.

Treatment and study plan

Transauricular Nerve Stimulation

Device

Hua Tuo brand SDZ-IIB electronic acupuncture therapy device and specially designed ear clips.

s-taVNS

Device

Hua Tuo brand SDZ-IIB electronic acupuncture therapy device and specially designed ear clips.

Primary outcomes

  1. Numeric Rating Scale (NRS-11) pain score during movement

    Time frame: 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 outcomes

  1. the proportion of patients with NRS pain score > 6

    Time frame: 24 hours postoperatively

    Assess the proportion of severe pain by calculating the ratio of NRS pain scores that are greater than 6.

  2. Epinephrine

    Time frame: 48 hours postoperatively

    Serum Epinephrine concentration.

  3. C-reactive protein (CRP)

    Time frame: 48 hours postoperatively

    Serum CRP concentration.

  4. NFκB

    Time frame: 48 hours postoperatively

    Serum NFκB concentration.

  5. aEP

    Time frame: 48 hours postoperatively

    Serum aEP concentration

  6. Postoperative adverse reactions

    Time frame: 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.

  7. Postoperative severe complications

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

Effect of Non-invasive Transcutaneous Vagus Nerve Stimulation for Pain Control After Cesarean Delivery - a Randomised Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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