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Transcutaneous auricular vagus nerve stimulation for postoperative analgesia after adult tonsillectomy: a randomized controlled trial

Transcutaneous auricular vagus nerve stimulation for postoperative analgesia after adult tonsillectomy: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121063
Enrollment
Unknown
Registered
2026-03-25
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic tonsillitis

Interventions

Transcutaneous auricular vagus nerve stimulation group:In addition to standard perioperative analgesia, participants receive transcutaneous auricular vagus nerve stimulation (taVNS) applied to the cym
Sham taVNS group:In addition to standard perioperative analgesia, participants receive sham stimulation with the same procedure and schedule as the intervention group but without effective vagal stimu

Sponsors

The First Hospital of Jiaxing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Patients scheduled for elective tonsillectomy. 2) Age 18–65 years. 3) Anesthesia and perioperative analgesia can be standardized according to the study protocol: general anesthesia with endotracheal intubation; baseline analgesic regimen including a single intraoperative intravenous bolus of dexamethasone 5 mg, and scheduled oral acetaminophen postoperatively. 4) Able to communicate effectively preoperatively, understand the study procedures, and complete pain assessments (able to use the NRS or the study-specified scale). 5) Willing to receive transcutaneous stimulation via a cymba conchae patch electrode and to comply with the prescribed number and duration of stimulation sessions; provides written informed consent. 6) ASA physical status I–II, clinically stable, and suitable for routine perioperative management.

Exclusion criteria

Exclusion criteria: 1) History or current evidence of clinically significant arrhythmia or conduction disorder (e.g., second- or third-degree atrioventricular block, marked sinus bradycardia), or a history of unexplained syncope; participants deemed by the investigator to have cardiovascular safety risks. 2) Implanted pacemaker, implantable cardioverter-defibrillator (ICD), or other implanted electronic medical devices that may be affected by electrical stimulation. 3) History of epilepsy/seizures, or any unprovoked seizure within the past 12 months. 4) Skin breakdown, infection, eczema/dermatitis, or significant allergic reaction at the stimulation site, making patch stimulation unsuitable; auricular deformity or other conditions preventing proper electrode placement or completion of the prescribed stimulation protocol. 5)Long-term preoperative opioid use, or a history of substance dependence/abuse that may interfere with postoperative pain assessment. 6)Known contraindication or severe allergy to the protocol-specified baseline analgesics, making it impossible to follow the standardized analgesic regimen.

Design outcomes

Primary

MeasureTime frame
Swallowing pain NRS score at 72 hours after tonsillectomy;

Secondary

MeasureTime frame
Resting pain NRS score at 72 hours after tonsillectomy;Swallowing pain NRS scores at 6, 24, 48 and 72 hours after tonsillectomy;Resting pain NRS scores at 6, 24, 48 and 72 hours after tonsillectomy;Time to first rescue analgesia after tonsillectomy;Adverse events;

Countries

China

Contacts

Public ContactRu Chen

The First Hospital of Jiaxing

allergychen@163.com+86 82519999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026