Effect of Dezocine Versus Nalbuphine Combined With Sufentanil on Postoperative Analgesia,
Background: Oral cancer radical surgery often requires free flap reconstruction. Postoperative pain is severe, and traditional opioids like sufentanil have side effects and may adversely affect tumor biology. Dezocine and nalbuphine are opioid agonist-antagonists with potentially better safety profiles. Their comparati
| Condition(s) | Oral Cancer, Postoperative Pain Management, Free Tissue Flaps, Mouth Neoplasms |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Background: Oral cancer radical surgery often requires free flap reconstruction. Postoperative pain is severe, and traditional opioids like sufentanil have side effects and may adversely affect tumor biology. Dezocine and nalbuphine are opioid agonist-antagonists with potentially better safety profiles. Their comparative effects on analgesia, complications, and flap survival in oral cancer surgery are unknown. Objective: To compare the efficacy of dezocine versus nalbuphine, both combined with sufentanil, for postoperative analgesia, and to evaluate their impact on postoperative complications and free flap survival/function in patients undergoing oral cancer radical surgery with flap reconstruction. Methods: This is a prospective, randomized, double-blind, controlled trial. Sixty eligible |
| Who can participate | Inclusion Criteria: 1. Diagnosed with oral malignant tumor. 2. Scheduled for oral cancer radical surgery with free flap reconstruction at Sun Yat-sen Memorial Hospital. 3. Age between 18 and 70 years. 4. Sign informed consent. Exclusion Criteria: 1. Use of analgesic medications within two weeks prior to surgery. 2. History of diabetes, arteriosclerosis, or peripheral vascular disease. 3. Use of hormones, chemotherapy, or immunosuppressants. 4. Severe cardiac, pulmonary, hematological, hepatic, or renal diseases. 5. Known allergy to the study drugs. |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2025-06-01 |
| NCT ID | NCT07401641 |
| Official listing | https://clinicaltrials.gov/study/NCT07401641 |