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

NCT ID: NCT06788561

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-05
• Study Completion Date: 2025-03-15

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.

Conditions

Postoperative Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transauricular Nerve Stimulation

Intervention Type: DEVICE

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

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.

Group Type: SHAM_COMPARATOR

s-taVNS

Intervention Type: DEVICE

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

Interventions

Transauricular Nerve Stimulation

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

Intervention Type: DEVICE

s-taVNS

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guyan Wang

Role: STUDY_DIRECTOR

Beijing Tongren Hospital

Locations

Beijing tongren Hospital, Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

TREC2024-KY089.R1

Identifier Type: -

Identifier Source: org_study_id