NCT07826806尚未招募2 期
Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Laparoscopic Hepatectomy--A Single-center, Randomized, Controlled Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 108
- 主要终点
- 1. Area under the NRS pain score curve 24 hours after medication (AUC-NRS24)
研究概览
简要总结
Efficacy and safety of Anrikefon injection for the treatment of postoperative pain in patients undergoing laparoscopic hepatectomy--A single-center, randomized, controlled clinical study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years, any gender;
- •American Society of Anesthesiologists (ASA) score of I or II;
- •BMI between 18 kg/m² and 30 kg/m²;
- •Patients scheduled for laparoscopic liver resection under general anesthesia, with surgery lasting less than 6 hours;
- •Surgical incision less than 10 cm;
- •Able to understand pain intensity assessment methods.
- •Participants understand the purpose and procedures of this study, voluntarily participate, and sign a written informed consent form.
排除标准
- •Patients allergic to opioids, flurbiprofen ester, or any other ingredients in the investigational drugs.
- •Patients expected to use continuous epidural analgesia or local block analgesia during the treatment period.
- •Patients with a history of gastrointestinal ulcers or bleeding who need treatment.
- •Patients undergoing emergency surgery or trauma.
- •Patients whose surgery needs to be converted to open abdominal surgery.
- •Patients unwilling to use patient-controlled intravenous analgesia (PCIA).
- •Patients with a history of upper abdominal surgery.
- •Patients expected to require postoperative continued intubation.
- •Patients needing postoperative admission to the ICU.
- •Patients with any of the following disease history or evidence before screening:
- •Severe cardiovascular or pulmonary diseases (myocardial infarction, heart failure, or respiratory failure).
- •Neurological or psychiatric history: brain injury, intracranial hypertension, schizophrenia, mania, etc., judged by the investigator as not suitable for the study.
- •History of digestive diseases: intestinal obstruction or other digestive system diseases that may cause nausea or vomiting as judged by the investigator; accompanied by other severe digestive tract issues affecting digestion (e.g., severe constipation, duodenal stasis syndrome, etc.), or other digestive diseases evaluated by the investigator as unsuitable for the study.
- •Patients with obvious chronic dizziness or diagnosed vestibular function disorders (other than motion sickness), including but not limited to peripheral vestibular syndrome or central vestibular syndrome.
- •Patients who received neoadjuvant treatment before surgery.
- •Patients who experienced nausea, retching, or vomiting within 24 hours before anesthesia induction (excluding bowel prep-related cases).
- •Known allergy or contraindication to other anesthetics or antiemetics that may be used during the trial.
- •Patients who used drugs with unclear half-lives that have analgesic or antiemetic effects within 14 days before randomization, or whose last use was less than 5 half-lives or the drug's effective duration (whichever is longer), including but not limited to opioids, non-opioid analgesics, antiemetics (or drugs with antiemetic effects), sedatives, anesthetics, corticosteroids, and other similar drugs.
- •Patients needing dialysis or who have alcoholism during treatment.
- •Pregnant or breastfeeding women, or those planning pregnancy during the study period or within 3 months after study completion.
- •Subjects the investigator believes have any other factor making them unsuitable for this clinical study.
研究组 & 干预措施
Anruikefen
Experimental
干预措施: Anrikefon Injection (Drug)
Flurbiprofen Ester
Placebo Comparator
干预措施: Flurbiprofen (Drug)
结局指标
主要结局
1. Area under the NRS pain score curve 24 hours after medication (AUC-NRS24)
时间窗: 24 hours after surgery
次要结局
- Pain intensity at rest and during movement (assess pain scores at 30 min, 1 h, 3 h, 6 h, 12 h, 24 h, 48 h, and 72 h after the first dose).(0-72 hours after surgery)
- Pain intensity difference (PID) at 30 min, 1, 3, 6, 12, 24, 48, and 72 h after dosing. Pain was assessed by NRS (0-10; 0=no pain, 10=severe pain). PID = baseline score (pre-dose/pre-op, 0 h) minus score at each time point. Unit: points.(0-72 hours after surgery)
- Sum of Pain Intensity Difference (SPID) at 30 min, 1, 3, 6, 12, 24, 48, and 72 h post-dose. NRS (0-10; 0=no pain, 10=worst pain) assessed pain. TPID = baseline score (pre-dose, 0 h) - score at each time point. Unit: points.(0-72 hours after surgery)
- Total Sufentanil dose administered via PCIA pump within 24 hours post-surgery. Measurement tool: PCIA pump (or electronic medical record). Measurement unit: micrograms (μg).(24 hours after surgery)
- Baseline, then assess NRS scores (visceral pain, incision pain, shoulder pain) at 30 min, 1 h, 3 h, 6 h, 12 h, 24 h, 48 h, and 72 h after the first dose.(0-72 hours after surgery)
- Use of rescue pain medication: cumulative usage of rescue pain medication (morphine injection mg) at 072h after the first dose(0-72 hours after surgery)
- The proportion of patients needing rescue pain relief within 72 hours after the first dose and the total amount of rescue medication used(0-72 hours after surgery)
- Incidence of nausea, vomiting, and PONV within 72 hours after the first dose(0-72 hours after surgery)
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