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.

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.

Study Overview

• Status: Recruiting
• Conditions: Oral Cancer; Mouth Neoplasms; Postoperative Pain Management; Free Tissue Flaps
• Intervention / Treatment: Drug: Dezocine and Sufentanil combination; Drug: Nalbuphine and Sufentanil combination

Detailed Description

Design: Single-center, prospective, randomized, double-blind, active-controlled, parallel-group trial.

Interventions:

Group D: Sufentanil (1.0 µg/kg) + Dezocine (0.4 mg/kg) diluted to 150ml with normal saline for PCIA (no basal infusion, bolus 2.5 ml, lockout 15 min).

Group N: Sufentanil (1.0 µg/kg) + Nalbuphine (1.0 mg/kg) diluted to 150ml with normal saline for PCIA (parameters identical to Group D).

Standardized general anesthesia protocol for both groups.

Primary Outcome: Postoperative pain scores (VAS, 0-10) at rest at 2, 24, and 48 hours after surgery.

Secondary Outcomes:

Flap survival status (e.g., hematoma, dehiscence, necrosis, infection) on postoperative days 1-7.

Flap sensory function: static/dynamic two-point discrimination and Semmes-Weinstein monofilament test on days 1-7.

Incidence of postoperative adverse events (nausea, vomiting, pruritus, dizziness, sedation).

Postoperative hospital stay duration.

Ramsay sedation scores at 2, 24, and 48 hours.

Intraoperative hemodynamics and blood loss.

Sample Size: 60 patients (30 per group). The calculation is based on a pilot study detecting a difference in 24h VAS scores (1.52 vs 2.35, SD=0.89) with 90% power and α=0.05, accounting for a 20% dropout rate.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ganglan Fu, M.D.; Phone Number: 86+13570275074; Email: ganglan@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Department of Anesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit
      • Contact: Ganglan Fu, Dr; Phone Number: 86+13570275074; Email: fugangl@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dezocine + Sufentanil; 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; 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.
Active Comparator: Nalbuphine + Sufentani; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Flap Complications	The occurrence of complications in the transferred free flap, assessed daily by clinical examination. Complications include hematoma, wound dehiscence, skin necrosis, and infection.	Daily from postoperative day 1 to day 7.
Flap Sensory Recovery - Two-Point Discrimination (2PD)	Sensory function recovery of the flap assessed using a Disk-Criminator to measure static and dynamic two-point discrimination (2PD). Lower values indicate better sensory discrimination.	Daily from postoperative day 1 to day 7.
Flap Sensory Recovery - Light Touch Threshold	Sensory function recovery of the flap assessed using Semmes-Weinstein monofilaments. The test determines the minimal force (g/mm²) required for the patient to perceive light touch, with lower values indicating better sensitivity.	Daily from postoperative day 1 to day 7.
Incidence of Postoperative Adverse Events	The frequency of common postoperative adverse effects, including nausea, vomiting, pruritus (itching), dizziness, and somnolence (drowsiness), as recorded in patient charts and through direct questioning.	From the end of surgery until 48 hours postoperatively.
Ramsay Sedation Score	Level of sedation assessed using the Ramsay Sedation Scale (scores 1-6, where 1=anxious/agitated, 2=cooperative/oriented/tranquil, 3=responsive to commands only, 4-6=asleep with varying responses to stimulus).	At 2 hours, 24 hours, and 48 hours after surgery.
Postoperative Hospital Stay Duration	The total length of hospitalization (in days) from the day of surgery until the day of discharge, meeting standard discharge criteria.	From the day of surgery until the day of discharge (assessed up to 30 days).
Intraoperative Hemodynamic Stability	Measurement of intraoperative stability, including heart rate (beats per minute), blood pressure (mmHg), and peripheral oxygen saturation (SpO2, %). Data points are recorded every 5 minutes.	From anesthesia induction until the end of surgery (intraoperative period).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flap Sensory Recovery - Pain Perception	Sensory function recovery of the flap assessed specifically for pain perception threshold. This is measured using an algesimeter, a device that applies a standardized, gradually increasing mechanical stimulus (e.g., pressure in grams or Newtons) to the flap surface until the patient first reports a sensation of pain. The threshold value (e.g., in grams) is recorded.	Daily from postoperative day 1 to day 7.
Long-term Flap Survival Rate	The viability of the free flap assessed clinically. Flap survival is defined as a viable, perfused flap without the need for emergency reoperation due to total necrosis. The outcome is reported as the percentage of patients with a fully surviving flap at each follow-up time point.	At 1 month, 6 months, and 1 year after surgery.
One-year Disease-free Survival	The proportion of patients alive without evidence of cancer recurrence (local, regional, or distant) at 1 year after surgery.	At 1 year after surgery.
Flap Sensory Recovery - Temperature Sensation	Sensory function recovery of the flap assessed specifically for temperature discrimination. This is measured using the Thissen temperature sensitivity test or similar calibrated thermodes. The test evaluates the ability to distinguish between warm and cold stimuli applied to the flap surface, typically reported as correct identification rates or threshold temperature differences	Daily from postoperative day 1 to day 7.
Flap Contour and Aesthetic Outcome	The aesthetic and contour outcome of the reconstructed site is assessed by a surgeon using a standardized visual analog scale (VAS). The assessor rates overall appearance, symmetry, and contour integration with surrounding tissues on a scale from 0 (very poor) to 10 (excellent). The mean VAS score at each time point will be reported.	At 1 month, 6 months, and 1 year after surgery.
Oromandibular Functional Recovery	Functional recovery related to the flap reconstruction is assessed using a patient-reported outcome measure (PROM) focusing on speech and swallowing.	At 1 month, 6 months, and 1 year after surgery.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Postoperative Analgesia; Nalbuphine; Dezocine; Oral Cancer Surgery; Free Flap Reconstruction; Flap Survival
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Mouth Neoplasms; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Nalbuphine; dezocine
• Other Study ID Numbers: SYSKY-2025-417-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No