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.

Overview

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.

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.

Interventions

• 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 infu
• 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 maximu

Primary outcome measures

• Postoperative Pain Intensity [Time frame: At 2 hours, 24 hours, and 48 hours after surgery.]

Secondary outcome measures (7)

• Incidence of Flap Complications [Time frame: Daily from postoperative day 1 to day 7.]
• Flap Sensory Recovery - Two-Point Discrimination (2PD) [Time frame: Daily from postoperative day 1 to day 7.]
• Flap Sensory Recovery - Light Touch Threshold [Time frame: Daily from postoperative day 1 to day 7.]
• Incidence of Postoperative Adverse Events [Time frame: From the end of surgery until 48 hours postoperatively.]
• Ramsay Sedation Score [Time frame: At 2 hours, 24 hours, and 48 hours after surgery.]
• Postoperative Hospital Stay Duration [Time frame: From the day of surgery until the day of discharge (assessed up to 30 days).]
• Intraoperative Hemodynamic Stability [Time frame: From anesthesia induction until the end of surgery (intraoperative period).]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

China · 1 center

• Department of Anesthesiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit — Guangzhou

Identifiers

NCT: NCT07401641 · SYSKY-2025-417-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗