Facial Plastic Surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female, aged 18–65 years; 2.Scheduled for elective facial aesthetic plastic surgery, including but not limited to rhinoplasty, facial rhytidectomy and lifting, double eyelid surgery, chin augmentation, etc. (The formal trial will only include surgical procedures with a mean peak postoperative VAS score >=4 at 6 hours as identified in the pilot study); 3.American Society of Anesthesiologists (ASA) Physical Status Classification of Class I or II; 4.Estimated operative time within 2 hours, with planned intraoperative local anesthetic infiltration (may be supplemented with intravenous sedation or general anesthesia); 5. Willingness to take oral analgesic medications for postoperative pain control as needed, and ability to understand and comply with the analgesic protocol of this study; 6.Capacity to understand and cooperate with the pain assessment process, and ability to accurately express pain intensity using the Visual Analogue Scale (VAS); 7.Voluntary participation in this study, with signed written informed consent after full understanding of the study content, risks, and rights.
Exclusion criteria
Exclusion criteria: 1.Known allergy or history of severe adverse reactions to non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, or to opioid analgesics; 2.Presence of contraindications to NSAID use, including but not limited to: Active peptic ulcer disease or history of gastrointestinal bleeding; Severe hepatic impairment (e.g., Child-Pugh Class C); Severe renal impairment (eGFR < 30 ml/min); Aspirin-exacerbated respiratory disease (triad syndrome); 3.History of asthma with documented NSAID-induced bronchospasm; 4.Comorbid severe psychiatric or neurological disorders that may interfere with subjective pain assessment (e.g., major depression, cognitive dysfunction); 5.Pregnant or lactating women (pregnancy must be excluded preoperatively); or women with postoperative pregnancy plans who refuse to adopt effective contraceptive measures; 6.Participation in other interventional clinical trials within 4 weeks prior to enrollment in this study; 7.Other medical or psychological factors deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak postoperative pain intensity at 6 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative pain exposure within 0–48 hours postoperatively; | — |
Countries
China
Contacts
Plastic Surgery Hospital, Chinese Academy of Medical Sciences