Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Free Tissue Flaps | — | UNRESOLVED | — |
| Mouth Neoplasms | Oral Cavity Neoplasm | ALIAS | 0.90 |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Postoperative Pain Management | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dezocine and Sufentanil combination | Drug | — | UNRESOLVED |
| Nalbuphine and Sufentanil combination | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dezocine + Sufentanil
- description
- Participants in this arm receive postoperative patient-controlled intravenous analgesia (PCIA) with a mixture of Sufentanil (1.0 µg/kg) and Dezocine (0.4 mg/kg), diluted to a total volume of 150 ml with normal saline. The PCIA pump is set with no basal infusion, a bolus dose of 2.5 ml, a lockout interval of 15 minutes, and a maximum hourly limit of 15 ml. This intervention begins at the end of surgery.
- interventionNames
- Drug: Dezocine and Sufentanil combination
- type
- ACTIVE_COMPARATOR
- label
- Nalbuphine + Sufentani
- description
- Participants in this arm receive postoperative patient-controlled intravenous analgesia (PCIA) with a mixture of Sufentanil (1.0 µg/kg) and Nalbuphine (1.0 mg/kg), diluted to a total volume of 150 ml with normal saline. The PCIA pump settings are identical to the experimental group: no basal infusion, a bolus dose of 2.5 ml, a lockout interval of 15 minutes, and a maximum hourly limit of 15 ml. This intervention begins at the end of surgery.
- interventionNames
- Drug: Nalbuphine and Sufentanil combination
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available