Идёт набор NCT07401641

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.

Без фазы С лечением Oral Cancer Postoperative Pain Management Free Tissue Flaps Mouth Neoplasms

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Dezocine and Sufentanil combination, Nalbuphine and Sufentanil combination.
Кому может быть актуально: Состояния в реестре: Oral Cancer, Postoperative Pain Management, Free Tissue Flaps, Mouth Neoplasms. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Препарат 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
Препарат 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

Первичные конечные точки

Postoperative Pain Intensity [Срок оценки: At 2 hours, 24 hours, and 48 hours after surgery.]

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

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.