Postoperative hyperanalgesia
Conditions
Interventions
Auricular point stimulation + esketamine group (S-A group):1. Continuous ear acupoint stimulation during perioperative period (transcutaneous vagus nerve stimulation one day before surgery, seed-press
2. Combined use of esketamine during anesthesia induction and maintenance (0.25 mg/kg for induction, 0.1 mg/kg/h for maintenance)
3. Standard anesthesia regimen (sufentanil, midazolam, cycloprofen, rocuronium)
4. Routine postoperative management.
Esketamine group (Group S):1. Sham ear acupoint stimulation (transcutaneous vagus nerve stimulation at the earlobe, minimal current, sham acupoint seed pressing)
Control Group (Group C):1. Sham ear acupoint stimulation (same as S group)
2. Use of normal saline instead of esketamine during anesthesia induction and maintenance
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adult female patients undergoing elective radical mastectomy or modified radical mastectomy under general anesthesia 2. Age 18-80 years 3. ASA II-III class 4. Received neoadjuvant chemotherapy containing taxanes and/or platinum-based drugs before surgery 5. Signed informed consent form with patient or family
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity to investigational drugs, auricular point application, or other contraindications 2. Severe diseases of the heart, brain, liver, kidney, lung, or endocrine system (ASA grade >III) 3. History of psychiatric disorders other than anxiety and depression 4. History of chronic pain or abnormal pain sensation caused by other reasons 5. History of pain from recent surgery and trauma 6. Breast cancer patients undergoing breast-conserving surgery, DIEP flap surgery, or other surgeries 7. Patients who have been taking sedative or analgesic drugs for a long time or are dependent on such drugs 8. Alcoholic patients 9. Patients with cognitive dysfunction 10. Pregnant or lactating women 11. Patients with local ear infection, trauma, or ear vascular abnormalities 12. Participants in another clinical study within the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mechanical allodynia incidence;Pain score (at rest and during movement);Area under the pain score curve; | — |
Secondary
| Measure | Time frame |
|---|---|
| Short-term recovery quality (physical function recovery and psychological status);Incidence of postoperative delirium;Intraoperative drug consumption;Rescue analgesic dose within 48 hours postoperatively;Complications during PACU emergence (nausea, vomiting, agitation);Long-term recovery quality (VAS score, chronic pain incidence, recovery quality, depressive state);Time from surgery to first postoperative chemotherapy;One-year tumor-free survival rate; | — |
Countries
China
Contacts
Public ContactPang Qianyun
Chongqing University Cancer Hospital
Outcome results
None listed