Clinical trial NCT06763913: TaVNS Reduces Postoperative Pain and Complications in Patients with Gastric and Intestinal Tumors
Official title: TaVNS Reduces Postoperative Pain and Complications in Patients with Gastric and Intestinal Tumors: a Randomized, Double-Blind, Parallel-Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: TaVNS
Gastrointestinal Tumor Surgery
Visual Analogue Scale
Complications
Keywords: taVNS
Perioperative period
Visual Analogue Scale
complications
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative acute pain control in patients with gastrointestinal tumors is not satisfactory, and surgical complications including gastrointestinal dysfunction, gastrointestinal fistula, abdominal and gastrointestinal hemorrhage, peritonitis and abscess, are still important factors affecting surgical outcomes, postoperative recovery, hospital stay, and even perioperative mortality. The application of taVNS during the perioperative period can enhance or preserve vagal nerve function, which may protect important organ functions through multiple pathways such as alleviating pain and inflammatory responses caused by surgical trauma, improving gastrointestinal function, enhancing cardiovascular regulation, reducing postoperative nausea and vomiting, and accelerating postoperative recovery, thereby reducing postoperative complications and mortality.

Detailed description: Subjects who met the inclusion criteria were enrolled in the clinical trial and received 2 interventions at the following times: the day before surgery, and the afternoon of the 1st day postoperatively (15:00-17:00), a total of 2 times. The intervention implementers used vagus nerve stimulation equipment to place electrodes in the tragus area of the outer ear of the subjects in the experimental group (taVNS group). The control group (sham stimulation group) was set to have a pulse width of 200 μs, a frequency of 1 Hz, and an initial current of 10 mA, which was gradually increased to the pain tolerance threshold of the subject, capped at 50 mA，last for one hour. The VAS scores before and after stimulation for 10 minutes were recorded.

2) ECG monitoring: Both groups were monitored with a dynamic ECG monitor during the intervention period, starting 10 minutes before stimulation and ending 10 minutes after stimulation. The SDNN (Standard Deviation of NN intervals) of the sinus rhythm was measured before and after stimulation for 10 minutes. A uniform standard was used for anesthesia induction and maintenance during surgery, and all patients used the same patient-controlled intravenous analgesia (PCIA) plan.

Eligibility criteria: Inclusion Criteria:

Age 18-80 years, BMI 18-30 kg/m², ASA Ⅱ-Ⅲ, elective laparoscopic gastric or intestinal tumor surgery, expected surgical duration ≥2 hours, patient understands study content and signs informed consent form.

Exclusion Criteria:

Kidney replacement therapy, treatment for arrhythmias requiring treatment, dementia, severe bradycardia, orthostatic tachycardia syndrome, neuro-muscular disorders, auricular dermatitis, planned post-operative transfer to ICU

Primary outcomes:
measure: Difference in VAS Score on Postoperative Day 1
timeFrame: before and after each stimulus for 10 minutes
Secondary outcomes:
measure: The QoR-15 scale scores on the 1st and 3rd days after surgery
timeFrame: 1 day before the operation and the third day after the operation
measure: Postoperative Complication Rate
timeFrame: 1 day before being discharged from the hospital
measure: The time of the first postoperative anal exhaust
timeFrame: On the third day after the operation
measure: The effective number of pain relief pump presses
timeFrame: One day before being discharged from the hospital
measure: Postoperative Salvage Analgesic Consumption of Opioid Equivalents
timeFrame: One day before being discharged from the hospital
measure: Length of hospital stay
timeFrame: One day before being discharged from the hospital
measure: Standard Deviation of NN intervals
timeFrame: 10 minutes before and after each stimulus
measure: Root Mean Square of the Successive Differences
timeFrame: 10 minutes before and after each stimulus
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second affiliated Hospital School of Medicine
state: Zhejiang
Study officials:
References: