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

Not Applicable

Completed

• Conditions: Postoperative Pain, Acute

• Registration Number: NCT06788561
• Lead Sponsor: Beijing Tongren Hospital

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.

Study Timeline

• Study First Submitted: 2024-12-19
• Status Verified: 2025-01
• Study Start: 2025-01-05
• Study First Submitted QC: 2025-01-21
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale (NRS-11) pain score during movement	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 Outcome Measures

Name	Time	Method
the proportion of patients with NRS pain score > 6	24 hours postoperatively	Assess the proportion of severe pain by calculating the ratio of NRS pain scores that are greater than 6.
Epinephrine	48 hours postoperatively	Serum Epinephrine concentration.
C-reactive protein (CRP)	48 hours postoperatively	Serum CRP concentration.
NFκB	48 hours postoperatively	Serum NFκB concentration.
aEP	48 hours postoperatively	Serum aEP concentration
Postoperative adverse reactions	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.
Postoperative severe complications	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).

Trial Locations

Locations (1)

Beijing tongren Hospital, Capital Medical University; 🇨🇳 Beijing, China