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.
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.
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.
Parallel
Dezocine and Sufentanil combination
DrugPostoperative 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.
Nalbuphine and Sufentanil combination
DrugPostoperative 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.
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.
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.
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.
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.
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.
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.
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.
One-year Disease-free Survival
The proportion of patients alive without evidence of cancer recurrence (local, regional, or distant) 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
Click on the lead sponsor to view all of their trials.
