Dezocine versus nalbuphine with sufentanil for pain control after oral cancer surgery with free-flap reconstruction
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07401641 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.