Dezocine versus nalbuphine with sufentanil for pain control after oral cancer surgery with free-flap reconstruction
Official title: Effect of Dezocine Versus Nalbuphine Combined With Sufentanil on Postoperative Analgesia, Complications, and Free Flap Survival in Patients Undergoing Oral Cancer Radical Surgery: A Randomized Controlled Clinical Trial.
Run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT07401641 · Data updated 2026-11-12
This will see if adding dezocine or nalbuphine to sufentanil reduces pain and complications for adults undergoing oral cancer surgery with free-flap reconstruction.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT07401641 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with diagnosed oral malignant tumors scheduled for radical oral cancer surgery with free flap reconstruction at the enrolling hospital who can give informed consent.
✕Probably not a fit
Patients with recent analgesic use, diabetes or peripheral vascular disease, severe organ dysfunction, use of hormones/chemotherapy/immunosuppressants, or known allergy to the study drugs are excluded and would not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, prospective, randomized, double-blind trial will enroll 60 adult patients undergoing radical oral cancer surgery with free flap reconstruction and randomize them 1:1 to postoperative PCIA with sufentanil plus either dezocine or nalbuphine. Both groups receive identical PCIA settings and a standardized general anesthesia protocol. The primary outcome is resting VAS pain at 2, 24, and 48 hours after surgery, with secondary outcomes including flap survival and complications, flap sensory function, common opioid-related adverse events, sedation scores, and length of hospital stay. Investigators will also record intraoperative hemodynamics and blood loss to explore differences between groups.
Why it matters
Potential benefit: If effective, the better combination could provide stronger postoperative pain relief with fewer side effects and potentially improve free flap outcomes and recovery time.
How similar studies have gone: Prior studies suggest dezocine and nalbuphine may have more favorable side-effect profiles than some pure opioids, but direct randomized comparisons in the setting of oral cancer free-flap surgery are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Department of Anesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Ganglan Fu, M.D.
- Email: ganglan@126.com
- Phone: 86+13570275074
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.