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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Dezocine and Sufentanil combination (Drug)
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.
干预措施: Nalbuphine and Sufentanil combination (Drug)
结局指标
主要结局
Postoperative Pain Intensity
时间窗: At 2 hours, 24 hours, and 48 hours after surgery.
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.
次要结局
- 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.)
- Postoperative Hospital Stay Duration(From the day of surgery until the day of discharge (assessed up to 30 days).)
- Intraoperative Hemodynamic Stability(From anesthesia induction until the end of surgery (intraoperative period).)