Clinical Study on the Effect of Tegileridine on Postoperative Pain in PatientsUndergoing Abdominal Surgery：A Randomized Controlled Double-blind Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Postoperative Visual Analog Scale(VAS)Pain Scores at Multiple Time Points
研究概览
简要总结
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of tegileridine fumarate injection for postoperative analgesia in adults experiencing moderate-to-severe pain after abdominal surgery. Participants will be randomized to receive intravenous tegileridine or matching placebo as part of a standardized multimodal analgesia protocol; all patients will have access to rescue opioid analgesia per institutional practice. The primary objective is to determine whether tegileridine improves postoperative pain control during the first 24-48 hours after surgery. Secondary objectives include comparing cumulative opioid consumption, time to first rescue analgesia, patient-reported satisfaction with pain control, recovery milestones (e.g., time to ambulation), and the incidence of adverse events such as nausea, vomiting, sedation, respiratory depression, pruritus, and constipation. Safety will be monitored throughout the study with predefined stopping and reporting procedures. The results aim to inform whether tegileridine can provide effective and well-tolerated analgesia for patients with moderate-to-severe postoperative pain following abdominal procedures.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-65 years; BMI 18-35 kg/m²; ASA physical status I-III.
- •Diagnosed with symptomatic gallbladder stone disease and scheduled for elective laparoscopic cholecystectomy under general anesthesia; expected procedure duration ≥60 minutes and postoperative hospitalization ≥24 hours.
- •Investigator expects moderate-to-severe postoperative pain; willing to receive standardized multimodal analgesia and protocolized rescue analgesia.
- •Able to understand pain scales (NRS/VAS) and provide written informed consent.
- •Women of childbearing potential: negative pregnancy test within 72 hours preoperatively and agreement to use effective contraception through 30 days after last dose.
排除标准
- •Known hypersensitivity to opioids or any component of the study drug.
- •Chronic opioid use/tolerance (e.g., ≥30 mg MME/day for ≥7 consecutive days within 30 days pre-op) or current methadone/buprenorphine therapy.
- •Planned/required neuraxial analgesia (epidural/spinal), continuous peripheral nerve blocks, or use of long-acting local anesthetic formulations that would confound postoperative pain assessment; brief intraoperative wound infiltration with short-acting local anesthetics is allowed if standardized.
- •Significant respiratory disease (e.g., uncontrolled obstructive sleep apnea, GOLD III-IV COPD) or anticipated postoperative mechanical ventilation >24 hours.
- •⑤Severe hepatic or renal impairment (Child-Pugh B/C; eGFR <30 mL/min/1.73 m²; or ALT/AST >3×ULN with total bilirubin >2×ULN).
- •⑥Clinically unstable cardiovascular or cerebrovascular disease (e.g., shock, uncontrolled arrhythmias, myocardial infarction or stroke within 6 months), or persistent SBP <90 mmHg.
- •⑦Concomitant medications that cannot be safely withheld: MAO inhibitors within 14 days; strong CNS depressants requiring continued use (e.g., benzodiazepines/barbiturates); mixed agonist-antagonist opioids (e.g., nalbuphine, buprenorphine) within 7 days.
- •⑧Severe psychiatric/neurologic disease or communication/cognitive impairment precluding valid pain scoring or follow-up.
- •⑨Pregnancy or breastfeeding; unwillingnebass to use contraception.
- •⑩Substance abuse (alcohol or drugs) within 12 months.
- •⑪Participation in another interventional study with study drug/device within 30 days.
- •⑫Any other condition that, in the opinion of the investigator, makes participation unsafe or impractical (e.g., severe active infection, planned ICU admission).
研究组 & 干预措施
Pre-incision tegileridine (T1 group）
Tegileridine 1 mg IV, diluted to 10 mL in 0.9% sodium chloride, infused over 10 minutes after anesthesia induction and before skin incision.
At skin closure, a matched 10 mL normal saline infusion is given. Rescue analgesia is permitted per institutional practice.
干预措施: Tegileridine (tegileridine fumarate injection, IV) (Drug)
End-of-surgery tegileridine（T2 group）
After anesthesia induction and before skin incision, a matched 10 mL normal saline infusion is given.
At skin closure, tegileridine 1 mg IV, diluted to 10 mL in 0.9% sodium chloride, is infused over 10 minutes. Rescue analgesia is permitted per institutional practice.
干预措施: Tegileridine (tegileridine fumarate injection, IV) (Drug)
Placebo Comparator（C group）
0.9% sodium chloride (normal saline, IV) - matched 10 mL infusion over 10 minutes administered at the alternate timepoint to maintain blinding.
干预措施: 0.9% Normal Saline (0.9% Sodium Chloride) injection (Other)
结局指标
主要结局
Postoperative Visual Analog Scale(VAS)Pain Scores at Multiple Time Points
时间窗: 2 hours ( h), 6 h, 12 h, 24 h, 36 h and 48 h after surgery
Pain intensity is assessed with the 10-cm Visual Analog Scale (minimum 0 = no pain, maximum 10 = worst imaginable pain) at rest by blinded assessors at 2 h, 6 h, 12 h, 24 h, 36 h and 48 h after surgery; lower scores indicate less pain. When rescue analgesia is required, VAS is recorded immediately before rescue dosing.
次要结局
- Intraoperative opioid consumption(Perioperative (induction of anesthesia to end of surgery).)
- Quality of Recovery-15 (QoR-15) Score(Day 1 and Day 2 postoperatively.)
- Richmond Agitation and Sedation Scale(RASS)(Immediately before removal of the endotracheal tube (Postoperative Day 0).)
研究者
Xin Chen
Associate Researcher,the Second Affiliated Hospital of Hainan Medical University
Hainan Medical College