[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pain-after-abdominal-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pain-after-abdominal-surgery":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100620106","phase-3-a-clinical-trial-evaluating-the-efficacy-safety-and-pharmacokinetic-profile-of-trd303-for-postoperative-analgesia-after-abdominal-surgery-in-china-100620106",false,"NCT07353307","A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Profile of TRD303 for Postoperative Analgesia After Abdominal Surgery in China.","To Evaluate the Efficacy, Safety and Pharmacokinetics of TRD303 Solution for Postoperative Analgesia After Abdominal Surgery in a Multicenter, Randomized, Double-blind, Placebo-positive Controlled Phase Ⅲ Clinical Trial","Inclusion Criteria:\n\n1. Fully understand the purpose and significance of this study, voluntarily participate in this study, voluntarily sign the informed consent, and voluntarily abide by the process of this study;\n2. 18 years old ≤ age ≤80 years old, regardless of gender; 18.0kg\u002Fm2≤BMI≤30.0kg\u002Fm2, ≥50.0kg for men and ≥45.0kg for women;\n\n4\\. American Society of Anesthesiologists (ASA) grade I-II (Appendix 1); (5) Elective abdominal surgery under general anesthesia, including laparoscopic or open surgery, and the length of the main incision is expected to be between 7±2cm (including the boundary value at both ends); 6. Can understand the research process and the use of various scales involved in this study, and can effectively communicate with researchers.\n\nExclusion Criteria:\n\n1. Those who are known to have allergies or contraindications to ropivacaine or other amide local anesthetics, inactive ingredients of the investigational drug, or other drugs that may be used during the trial, and who are judged by the investigator to be unsuitable for the trial;\n2. Use of the following drugs for less than 5 half-lives before randomization (according to the actual drug instructions, the half-life is unknown, or eluted according to 48 hours), including but not limited to: Class III antiarrhythmic drugs, glucocorticoids (systemic), anticonvulsants, sedative-hypnotic drugs, anxiolytic drugs, antidepressant drugs, CYP1A2 enzyme inhibitor, sedative drugs (except those used according to the protocol), analgesic drugs (except those used according to the protocol), the specific types refer to the list of prohibited drugs; Use of Chinese herbal medicine with definite analgesic effect assessed by investigators within 7 days before randomization;\n3. Participants who planned to use hyperthermic perfusion, intraperitoneal chemotherapy, physical therapy, or other concomitant therapies during the treatment period that the investigator judged might affect postoperative pain;\n4. patients who underwent abdominal surgery within 1 year before signing ICF;\n5. patients who planned to undergo surgery at other sites during the study period;\n6. Combined with other pain conditions that may confound the evaluation of postoperative pain according to the investigator;\n7. Participants with a history of congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency;\n8. Previous and\u002For family history of malignant hyperthermia;\n9. Participants with poorly controlled blood pressure during screening (systolic blood pressure ≥160mmHg or ≤90 mmHg while sitting during screening, and\u002For diastolic blood pressure ≥100 mmHg or ≤60mmHg during screening, excluding abnormal blood pressure during anesthesia), whose abnormalities were judged by the investigator to be clinically significant and increase perioperative risk;\n10. Heart rate \\\u003C 50 beats\u002Fmin or heart rate \\> 100 beats\u002Fmin during screening (excluding abnormal heart rate during anesthesia), and the abnormal heart rate was judged by the investigator to be clinically significant; QTcF \\> 450ms in men and \\> 470ms in women \\[QTcF=QT\u002F (RR\\^0.33)\\]; Or a history of severe arrhythmias such as atrioventricular block of degree II or higher, or cardiac insufficiency;\n11. Patients with severe liver, kidney, cardiovascular, cerebrovascular, or metabolic diseases judged by the investigator to be unsuitable for the trial;\n12. Patients with advanced malignant tumors who were judged by the investigators to be not suitable for participating in the trial;\n13. Patients with a history of mental diseases (such as schizophrenia, depression, etc.), dementia, migraine, or epilepsy, who were judged by the investigator to be unfit for the trial;\n14. Patients with skin infection, ulceration or scar constitution around the incision, judged by the investigator to be not suitable for the trial;\n15. Participants with a history of psychoactive and narcotic drug abuse, drug use, and heavy drinking (i.e., drinking an average of more than 2 units of alcohol per day (1 unit =360mL of beer or 45mL of 40% liquor or 150 ml of wine) in the year before randomization;","ALL","18 Years","80 Years",{"count":20,"type":21},333,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","A multicenter, randomized, double-blind, placebo-positive, parallel-controlled, phase Ⅲ clinical trial of the efficacy, safety and pharmacokinetics of TRD303 solution for postoperative analgesia in patients undergoing abdominal surgery was conducted. The primary objective was to evaluate the efficacy of TRD303 solution for postoperative analgesia after abdominal surgery. The secondary objective was to evaluate the safety and pharmacokinetic profile of TRD303 solution for postoperative analgesia after abdominal surgery.",[27],"Pain After Abdominal Surgery","RECRUITING","2026-03-25",{"date":31,"type":32},"2026-03-27","ACTUAL",{"date":34,"type":32},"2025-12-30",{"date":36,"type":21},"2026-12-30",{"name":38,"class":39},"The Third Xiangya Hospital of Central South University","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":59,"locationsCount":5},"100630705","phase-2-phase-ii-clinical-study-of-the-efficacy-and-safety-of-hsk55718-in-the-treatment-of-abdominal-postoperative-pain-100630705","NCT07491146","Phase II Clinical Study of the Efficacy and Safety of HSK55718 in the Treatment of Abdominal Postoperative Pain","To Evaluate the Efficacy and Safety of HSK55718 for Injection in Patients With Abdominal Postoperative Pain: a Multicenter, Randomized, Double-blind, Placebo\u002FPositive Control Phase II Clinical Trial.","Inclusion Criteria:\n\n1. Fully understand, voluntarily participate in this study and sign the informed consent;\n2. Age ≥18 years old, both sexes;\n3. Undergo elective abdominal surgery (open or laparoscopic) with a (estimated) duration of ≥1 hour under general anesthesia;\n4. 18.0 kg\u002Fm2≤ body mass index (BMI) ≤30.0 kg\u002Fm2\n5. American Society of Anesthesiologists (ASA) grade ⅰ-ⅱ;\n6. NRS≥4 in the resting state at any time within 4 hours after the end of surgery;\n7. Be able to comply with the follow-up schedule and other program requirements;\n8. Participants agreed to use highly effective contraception for the entire duration of the study, from the time they signed the ICF until 3 months after the last dose of the investigational product was administered.\n\nExclusion Criteria:\n\n1\\. Disease status\n\n1. History of vestibular dysfunction or dizziness, nausea, retching or vomiting within 1 week before screening;\n2. Cardiovascular history: severe superior vena cava obstruction syndrome, severe pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction within 6 months before screening, or severe arrhythmia such as atrioventricular block of degree Ⅱ or above, or history of NYHA class II or above;\n3. Respiratory history: history of severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, tracheoesophageal fistula or airway tear, and severe respiratory infection within the last 2 weeks before screening;\n4. History of nervous and mental system: history of craniocerebral injury, convulsion, intracranial hypertension, cerebral aneurysm, cerebrovascular accident, ischemic stroke or transient ischemic attack (TIA); History of schizophrenia, mania, psychosis, long-term use of psychotropic drugs, cognitive dysfunction, etc. Depression, anxiety, epilepsy history, etc.\n5. cancer participants with advanced cancer or extensive metastases; 2. Laboratory tests during screening meet any of the following criteria:\n\n(1) Blood routine: white blood cell count \\\u003C 3.0×109\u002FL; Platelet count \\\u003C 80×109\u002FL; Hemoglobin \\\u003C 70 g\u002FL; (2) Coagulation function: prothrombin time (PT) prolongation exceeded the upper limit of normal value for 3 seconds; Activated partial thromboplastin time (APTT) prolonged more than 10 seconds; (3) Liver and kidney function: alanine aminotransferase and\u002For aspartate aminotransferase \\> 2×ULN; Total bilirubin \\> 2×ULN; Serum creatinine \\> 1.5×ULN; (4) Fasting blood glucose ≥11.1 mmol\u002FL; (5) Participants who did not receive regular antihypertensive treatment or whose blood pressure was poorly controlled (systolic blood pressure ≥160mmHg or ≤90mmHg at screening, and\u002For diastolic blood pressure ≥100mmHg or ≤60mmHg at screening, excluding abnormalities during anesthesia from admission to PACU and during recovery from anesthesia); (6) QTc \\>450ms in men and \\>470ms in women (QTc was calculated with Fridericia's formula); (7) Transcutaneous oxygen saturation (SpO2) \\\u003C90% during screening (excluding abnormal anesthesia from admission to PACU and anesthesia recovery period); (8) Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody and human immunodeficiency virus (HIV) antibody were positive during the screening period; 3. Medication use\n\n1. Patients with a history of severe drug allergy, or other drugs that may be used during the trial, such as anesthetics propofol\u002Fsevoflurane, rocuronium, antiemetic drugs, or drugs and their excipients;\n2. Taking opioid analgesics for any reason for more than 10 consecutive days within 3 months before randomization;\n3. Drugs that may affect the evaluation of efficacy if the time interval between the last administration of the drug and randomization is less than five half-lives of the drug, including but not limited to the following drugs: Selective α2-adrenoceptor agonists, opioid agonists\u002Fantagonists, non-steroidal anti-inflammatory drugs, sedative drugs, monoamine oxidase inhibitors, glucocorticoids, antiepileptic, anxiolytic, antidepressant and other antipsychotic drugs. Refer to the list of banned drugs for specific types.\n4. Use of a strong inducer or inhibitor of CYP3A within 14 days or 5 half-lives before the first dose of the investigational drug, whichever is longer; 4: Others\n\n(1) Having a history of drug abuse, drug abuse and\u002For alcohol abuse in the past year, with alcohol abuse defined as drinking an average of \\> 2 units of alcohol per day (1 unit =360mL of 5% beer or 45mL of 40% liquor or 150mL of wine); (2) Positive results of drug abuse screening during the screening period; (3) Pregnant or lactating women; (4) Had participated in other drug clinical trials (defined as receiving investigational drug or placebo) within 3 months before the screening period; (5) Any sensory dysfunction that may interfere with the ability to assess postoperative pain according to the investigator's judgment; (6) Painful physical conditions that may interfere with postoperative evaluation according to the investigator's judgment; (7) Participants had medical complications during the operation and were not suitable for further study according to the investigator's judgment; (8) Participants with any other factors considered by the investigator to be ineligible for the clinical study.",{"count":48,"type":21},200,[50],"PHASE2","A multicenter, randomized, double-blind, placebo-controlled, and positive-controlled phase II clinical trial was conducted to evaluate the efficacy and safety of HSK55718 injection for postoperative analgesia in patients undergoing abdominal surgery. The primary objective was to evaluate the efficacy of HSK55718 for postoperative analgesia after abdominal surgery. The secondary objective was to evaluate the safety and pharmacokinetic profile of TRD303 solution for postoperative analgesia after abdominal surgery.",[27],"NOT_YET_RECRUITING","2026-03-19",{"date":56,"type":32},"2026-03-24",{"date":29,"type":21},{"date":36,"type":21},{"name":60,"class":39},"Yingyong Zhou,MD,PhD"]