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

NCT06788561 | Completed DMC

• 1 other identifier: TREC2024-KY089.R1
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain, Acute

Keywords

Transcutaneous auricular vagus nerve stimulation (taVNS); Auricular acupoint; Cesarean section; Postoperative pain; Inflammatory response

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours postoperatively

Secondary Outcomes (7)

• the proportion of patients with NRS pain score > 6

  24 hours postoperatively

• Epinephrine

  48 hours postoperatively

• C-reactive protein (CRP)

  48 hours postoperatively

• NFκB

  48 hours postoperatively

• aEP

  48 hours postoperatively

Study Arms (2)

Transcutaneous auricular vagus nerve stimulation (taVNS)

EXPERIMENTAL

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

Sham transcutaneous auricular vagus nerve stimulation (s-taVNS)

SHAM COMPARATOR

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

Interventions

Transauricular Nerve Stimulation DEVICE

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

Transcutaneous auricular vagus nerve stimulation (taVNS)

s-taVNS DEVICE

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

Sham transcutaneous auricular vagus nerve stimulation (s-taVNS)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing tongren Hospital, Capital Medical University

Beijing, 100730, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Guyan Wang

  Beijing Tongren Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 23, 2025
• Study Start: January 5, 2025
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-01

Locations

CN (1)