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

March 24, 2025 updated by: Beijing Tongren Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Beijing Tongren Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous auricular vagus nerve stimulation (taVNS)
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.
Device: Transauricular Nerve Stimulation
Hua Tuo brand SDZ-IIB electronic acupuncture therapy device and specially designed ear clips.
Sham Comparator: Sham transcutaneous auricular vagus nerve stimulation (s-taVNS)
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.
Device: s-taVNS
Hua Tuo brand SDZ-IIB electronic acupuncture therapy device and specially designed ear clips.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein (CRP)
Time Frame: 48 hours postoperatively
Serum CRP concentration.
48 hours postoperatively
NFκB
Time Frame: 48 hours postoperatively
Serum NFκB concentration.
48 hours postoperatively
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.
From date of randomization until the date of discharge, assessed up to 7 days
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).
From date of randomization until the date of discharge, assessed up to 7 days
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.
24 hours postoperatively
Epinephrine
Time Frame: 48 hours postoperatively
Serum Epinephrine concentration.
48 hours postoperatively
aEP
Time Frame: 48 hours postoperatively
Serum aEP concentration
48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Investigators

  • Study Director: Guyan Wang, Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2025

Primary Completion (Actual)

March 15, 2025

Study Completion (Actual)

March 15, 2025

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TREC2024-KY089.R1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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