Postoperative Pain, AcuteNCT06788561
Effect of Transcutaneous Vagus Nerve Stimulation for Pain Control After Cesarean Delivery
A study testing Transauricular Nerve Stimulation and s-taVNS in people with Postoperative Pain, Acute, run by Beijing Tongren Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Transauricular Nerve Stimulation and s-taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2025to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing tongren Hospital, Capital Medical University
Beijing, 100730
About this study
Official title: 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.
Read the 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
- Being tested
- Transauricular Nerve Stimulation, s-taVNS
- Keywords
- Transcutaneous auricular vagus nerve stimulation (taVNS), Auricular acupoint, Cesarean section, Postoperative pain, Inflammatory response
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transauricular Nerve StimulationDevice
Hua Tuo brand SDZ-IIB electronic acupuncture therapy device and specially designed ear clips.
s-taVNSDevice
Hua Tuo brand SDZ-IIB electronic acupuncture therapy device and specially designed ear clips.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: s-taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
Secondary outcomes (7)
the proportion of patients with NRS pain score > 6
Assess the proportion of severe pain by calculating the ratio of NRS pain scores that are greater than 6.
Measured: 24 hours postoperatively
Epinephrine
Serum Epinephrine concentration.
Measured: 48 hours postoperatively
C-reactive protein (CRP)
Serum CRP concentration.
Measured: 48 hours postoperatively
NFκB
Serum NFκB concentration.
Measured: 48 hours postoperatively
aEP
Serum aEP concentration
Measured: 48 hours postoperatively
Postoperative adverse reactions
Explore whether taVNS intervention increases postoperative adverse reactions, including dizziness, bloating, itching and so on.
Measured: From date of randomization until the date of discharge, assessed up to 7 days
Postoperative severe complications
Postoperative severe complications, including pulmonary complications, liver function abnormalities, heart function abnormalities, kidney function abnormalities, and SIRS (Systemic Inflammatory Response Syndrome).
Measured: From date of randomization until the date of discharge, assessed up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start5 Jan 2025
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guyan Wang, Study director, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788561
- Sponsor's protocol ID
- TREC2024-KY089.R1
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-invasive Transcutaneous Vagus Nerve Stimulation for Pain Control After Cesarean Delivery - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06788561
- Acronym / sponsor ID
- TREC2024-KY089.R1
- Conditions
- Postoperative Pain, Acute
- Keywords
- Transcutaneous auricular vagus nerve stimulation (taVNS), Auricular acupoint, Cesarean section, Postoperative pain, Inflammatory response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulation (taVNS) | Experimental | Device: Transauricular Nerve StimulationBilateral 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. |
| Sham transcutaneous auricular vagus nerve stimulation (s-taVNS) | Sham comparator | Device: s-taVNSBilateral 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transauricular Nerve StimulationHua Tuo brand SDZ-IIB electronic acupuncture therapy device and specially designed ear clips. | Device | Transcutaneous auricular vagus nerve stimulation (taVNS) |
| s-taVNSHua Tuo brand SDZ-IIB electronic acupuncture therapy device and specially designed ear clips. | Device | Sham transcutaneous auricular vagus nerve stimulation (s-taVNS) |
Primary outcome
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.
7 secondary outcomes
the proportion of patients with NRS pain score > 6
Time frame: 24 hours postoperatively
Epinephrine
Time frame: 48 hours postoperatively
C-reactive protein (CRP)
Time frame: 48 hours postoperatively
NFκB
Time frame: 48 hours postoperatively
aEP
Time frame: 48 hours postoperatively
Postoperative adverse reactions
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guyan Wang study director
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transauricular Nerve Stimulation and s-taVNS in people with Postoperative Pain, Acute, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS-11) pain score during movement (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.