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Clinical Application Study of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Visceral Pain Following Laparoscopic Gastrointestinal Surgery

Clinical Application Study of Transcutaneous Auricular Vagus Nerve Stimulation for Postoperative Visceral Pain Following Laparoscopic Gastrointestinal Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108061
Enrollment
Unknown
Registered
2025-08-25
Start date
2025-08-25
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Visceral pain

Interventions

Transcutaneous auricular vagus nerve stimulation group.:Electrical stimulation of the ear vagus nerve is performed in the auricular region.
Control group:Stimulate the non-vagal nerve areas such as the edge of the earlobe as a "false stimulation" control.

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. To undergo elective laparoscopic gastrointestinal surgery; 2. Age 18-70 years old, ASA classification I-III; 3. Clear consciousness, normal comprehension ability, and able to independently and clearly answer questions; 4. Fully understand and voluntarily participate in this study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. There were already other acute or chronic pains before the surgery; 2. Had been receiving opioid medication for a long time or had used any analgesics 48 hours before the surgery; 3. Patients who had received vagus nerve stimulation or acupuncture treatment within 1 month before the study; 4. Had a history of severe cardiovascular or cerebrovascular diseases, abnormal liver and kidney functions, or endocrine disorders before the surgery; 5. Had serious complications that required further monitoring in the ICU after the surgery; 6. Had a history of ear trauma, skin diseases, or other conditions that prevented the use of the stimulator; 7. Had cognitive impairments and speech expression defects, making it difficult to cooperate with the investigators.

Design outcomes

Primary

MeasureTime frame
Incidence of Moderate-to-Severe Movement-Evoked Visceral Pain at 24 Hours Postoperatively;

Secondary

MeasureTime frame
The incidence of moderate to severe visceral pain induced by moderate to intense exercise at 48 hours and 72 hours after the operation;Postoperative resting and exercise-induced visceral pain scores;Postoperative rest and exercise-induced incision pain scores;Remedy analgesia rate within 48 hours;Opioid consumption;Anxiety and depression scores;Postoperative recovery quality;The occurrence of postoperative adverse reactions;inflammatory factor(IL-1ßIL-6TNF-a);Stress hormones (CRH, CORT);Gut microbiota (intestinal microbial diversity, community composition, richness);Heart rate variablity;

Countries

China

Contacts

Public ContactZiyang Chen

The First Affiliated Hospital of Nanjing Medical University

chenzy0627@126.com+86 135 1251 6397

Outcome results

None listed

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