NCT07401641 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.
| NCT ID | NCT07401641 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Condition | Oral Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-06-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 patients (aged 18-70, ASA I-III) will be randomly assigned (1:1) to receive postoperative patient-controlled intravenous analgesia (PCIA) with either Sufentanil + Dezocine or Sufentanil + Nalbuphine. The primary outcome is pain intensity assessed by the Visual Analogue Scale (VAS) at 2, 24, and 48 hours postoperatively. Secondary outcomes include flap survival status, sensory function recovery, incidence of adverse events (e.g., nausea, vomiting), and hospitalization duration. Potential Impact: This study may identify a superior postoperative analgesic regimen that provides effective pain relief while potentially improving flap outcomes and minimizing side effects for oral cancer patients.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07401641 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Oral Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07401641 currently recruiting?
Yes, NCT07401641 is actively recruiting participants. Contact the research team at ganglan@126.com for enrollment information.
Where is the NCT07401641 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07401641 clinical trial?
NCT07401641 is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. The trial plans to enroll 60 participants.
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