Postoperative Pain
Conditions
Interventions
taVNS Group :Before use, disinfect and degrease the device and the stimulating area of the ear with a 75% alcohol swab to ensure effective contact. Then place the stimulator on the left ear to ensure
maximum tolerable intensity that can detect stimulation but is painless
Stimulus for 30 seconds/stop for 10 seconds, set the total duration to 40 minutes, so that the effective stimulation duration is 30 minutes) and intraoperative (pulse width: 200us
maximum tolerance intensity that can be perceived but painless before anesthesia induction after entering the room
Stimulate for 60 seconds/stop for 10 seconds
The duration of stimulation is correlated with the duration of surgery, and taVNS stimulation is performed.
Sham Group :Both preoperative and intraoperative, electrodes were placed at the same position as the intervention group for sham stimulation (preoperative activation of taVNS allowed patients to feel
Intraoperative placement without activation
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years old 2. ASA Classification I-III 3. 18kg/m^2<BMI=30kg/m^2 4. Confirmed by nasal endoscopy and/or sinus CT, with symptoms lasting for more than 12 weeks (in accordance with the Chinese Guidelines for Diagnosis and Treatment of Chronic Sinusitis), excluding CRS secondary to other diseases (such as secondary to odontogenic diseases, fungal infections, cystic fibrosis, primary ciliary immobility syndrome, vasculitis, immunoglobulin related diseases, and immune deficiencies); 5. Preoperative imaging and endoscopy only indicate chronic sinusitis/nasal polyps, without other space occupying lesions, bone destruction, soft tissue infiltration, fungal tendency, etc; 6. First FESS, or previous partial sinus opening without extensive scarring; 7. For patients with combined heart, lung, liver, kidney, thyroid dysfunction and coagulation dysfunction, the control level is better than the corresponding values listed in the exclusion criteria; 8. Able to understand, read, and sign informed consent forms, with a minimum of 9 years of education, normal language and cognitive function, and able to cooperate with the research process.
Exclusion criteria
Exclusion criteria: 1. Refusing to sign informed consent; 2. Language or cognitive impairment: individuals with articulation disorders, aphasia, dementia, previous brain surgery, or any neurodegenerative disease who are unable to fully express or understand instructions; 3. Serious mental illnesses: schizophrenia (including suicidal/self injurious tendencies), bipolar disorder, autism spectrum disorder, attention deficit hyperactivity disorder, and other diagnosed conditions that affect cooperation; Neurological disorders (such as epilepsy, Parkinson's disease, multiple sclerosis, myasthenia gravis, muscular dystrophy, etc.) 4. Combined with other chronic pain or neuropathy: lower back pain, neck and shoulder pain, migraine, trigeminal neuralgia, fibromyalgia syndrome, phantom limb pain after amputation, etc; Diabetes peripheral neuropathy, peripheral nerve injury caused by any reason, or vagus nerve dysfunction/hyperreflexia diagnosed in the past; 5. Recent intervention or medication: those who have received or are currently receiving any form of peripheral nerve regulation intervention in the past 4 weeks (including but not limited to acupuncture and moxibustion/electroacupuncture, ear point pressing, transcranial magnetic stimulation, transcutaneous auricular vagus nerve stimulation, transcutaneous electric nerve stimulation, peripheral nerve block, nerve radiofrequency ablation, spinal cord or peripheral nerve electrical stimulation); History of using opioid analgesics in the past 4 weeks; 6. Ear taboos: individuals with metal allergies, congenital (ear deformities) or acquired (ear trauma, infection, surgery, ear skin perception disorders, etc.) causing structural or functional abnormalities in the ear that cannot be coordinated, severe skin diseases (such as severe eczema or dermatitis); 7. Having implantable devices (such as pacemakers, defibrillators, cochlear implants, deep brain stimulators, orthopedic metal implants that affect the electromagnetic field around the ear); 8. Accompanied by severe heart, lung, liver, kidney, thyroid dysfunction and coagulation dysfunction [ a. Hypertension: systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 110 mmHg, or requiring maintenance with intravenous antihypertensive drugs; b. Heart failure: NYHA grade III or IV, or left ventricular ejection fraction= 2.5 s, or any arrhythmia requiring medication/device treatment; d. Within the past 3 months, there has been angina pectoris induced by resting or low activity, or it has been diagnosed as unstable angina pectoris; Acute myocardial infarction (STEMI/NSTEMI) occurred within the past 6 months; e. Liver function: Child Pugh classification >= B or ALT/AST>3 × ULN; f. Pulmonary function: FEV1/FVC= 15 hours/day) or long-term non-invasive ventilation is required; Arterial blood gas (without oxygen inhalation): PaO250 mmHg; g. Renal function: eGFR10 mIU/L, or TSH 4.5-10 mIU/L with normal FT4 but medication needs to be adjusted in the past 3 months; i. Coagulation dysfunction: Any active bleeding in any part of the body that requires medical intervention within the past 7 days (including but not limited to persistent nasal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sum of Pain Intensity Differences 12, SPID 12 ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Standardized Body-weight-adjusted 18 Analgesic Dose,SBAD ;Postoperative activity status NRS score ;Sum of Pain Intensity Differences 24,SPID 24 ;Postoperative resting state NRS score ;Postoperative (48h) consumption of remedial analgesic drugs ;Area Under the Pain Intensity-Time Curve,AUPITC 24 ; | — |
Countries
China
Contacts
Public ContactLihua Peng
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed