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.

NCT07401641 | Recruiting

• 1 other identifier: SYSKY-2025-417-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer; Postoperative Pain Management; Free Tissue Flaps; Mouth Neoplasms

Keywords

Dezocine; Nalbuphine; Oral Cancer Surgery; Free Flap Reconstruction; Postoperative Analgesia; Randomized Controlled Trial; Flap Survival

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity

  Pain intensity assessed at rest using the Visual Analogue Scale (VAS). The VAS is a 100-mm horizontal line where 0 mm represents "no pain" and 100 mm represents "the worst pain imaginable." Patients mark their current pain level on the line.

  At 2 hours, 24 hours, and 48 hours after surgery.

Secondary Outcomes (7)

• Incidence of Flap Complications

  Daily from postoperative day 1 to day 7.

• Flap Sensory Recovery - Two-Point Discrimination (2PD)

  Daily from postoperative day 1 to day 7.

• Flap Sensory Recovery - Light Touch Threshold

  Daily from postoperative day 1 to day 7.

• Incidence of Postoperative Adverse Events

  From the end of surgery until 48 hours postoperatively.

• Ramsay Sedation Score

  At 2 hours, 24 hours, and 48 hours after surgery.

Other Outcomes (6)

• Flap Sensory Recovery - Pain Perception

  Daily from postoperative day 1 to day 7.

• Long-term Flap Survival Rate

  At 1 month, 6 months, and 1 year after surgery.

• One-year Disease-free Survival

  At 1 year after surgery.

Study Arms (2)

Dezocine + Sufentanil

EXPERIMENTAL

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.

Drug: Dezocine and Sufentanil combination

Nalbuphine + Sufentani

ACTIVE COMPARATOR

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.

Drug: Nalbuphine and Sufentanil combination

Interventions

Dezocine and Sufentanil combination DRUG

Postoperative patient-controlled intravenous analgesia (PCIA) regimen. The intervention consists of a mixture of two drugs: Sufentanil (at a dose of 1.0 µg per kg of body weight) and Dezocine (at a dose of 0.4 mg per kg). This combination is diluted with normal saline to a total volume of 150 ml and administered via a PCIA pump. The pump is programmed with no background infusion, a patient-controlled bolus of 2.5 ml, a lockout interval of 15 minutes, and a maximum hourly limit of 15 ml. The infusion begins at the end of surgery.

Dezocine + Sufentanil

Nalbuphine and Sufentanil combination DRUG

Postoperative patient-controlled intravenous analgesia (PCIA) regimen. The intervention consists of a mixture of two drugs: Sufentanil (at a dose of 1.0 µg per kg of body weight) and Nalbuphine (at a dose of 1.0 mg per kg). This combination is diluted with normal saline to a total volume of 150 ml and administered via a PCIA pump. The pump settings are identical to the comparator regimen: no background infusion, a patient-controlled bolus of 2.5 ml, a lockout interval of 15 minutes, and a maximum hourly limit of 15 ml. The infusion begins at the end of surgery.

Nalbuphine + Sufentani

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with oral malignant tumor.
• Scheduled for oral cancer radical surgery with free flap reconstruction at Sun Yat-sen Memorial Hospital.
• Age between 18 and 70 years.
• Sign informed consent.

You may not qualify if:

• Use of analgesic medications within two weeks prior to surgery.
• History of diabetes, arteriosclerosis, or peripheral vascular disease.
• Use of hormones, chemotherapy, or immunosuppressants.
• Severe cardiac, pulmonary, hematological, hepatic, or renal diseases.
• Known allergy to the study drugs.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Department of Anesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

dezocine; Nalbuphine

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Ganglan Fu, M.D.

CONTACT

86+13570275074; ganglan@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 10, 2026
• Study Start: June 1, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2025-12

Locations

CN (1)