TRD303 for pain after abdominal surgery

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

This test will see if TRD303 gives adults better pain relief and is safe after abdominal surgery compared with ropivacaine or placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 333 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Third Xiangya Hospital of Central South University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Changsha, Hunan and 1 other locations)
• Trial ID: NCT07353307 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, double-blind, parallel-controlled Phase 3 trial in China comparing TRD303 solution to ropivacaine and saline for postoperative analgesia after elective abdominal surgery. Adults aged 18–80 with ASA grade I–II and a planned main incision length of about 7±2 cm are randomized to receive one of the study solutions. The primary outcome is postoperative pain control, with secondary assessments of safety and pharmacokinetics. Participants are followed for pain measures, adverse events, and drug concentration sampling per protocol.

Who should consider this trial

Good fit: Adults 18–80 years old, BMI 18–30 kg/m2, ASA I–II, scheduled for elective abdominal surgery with an expected main incision of about 7±2 cm, who can give informed consent and communicate with study staff.

Not a fit: People with known allergy or contraindication to ropivacaine or other amide local anesthetics, or those undergoing different types of surgery or with higher ASA status, are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, TRD303 could provide stronger or longer-lasting pain relief with an acceptable safety profile, potentially reducing the need for systemic opioids after abdominal surgery.

How similar studies have performed: Local anesthetic approaches such as ropivacaine are well-established for postoperative pain, while TRD303 is a new formulation undergoing phase 3 testing to confirm comparable or improved effect.

Eligibility criteria

Inclusion Criteria:

1. 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;
2. 18 years old ≤ age ≤80 years old, regardless of gender; 18.0kg/m2≤BMI≤30.0kg/m2, ≥50.0kg for men and ≥45.0kg for women;

4\. 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.

Exclusion Criteria:

1. 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;
2. 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;
3. 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;
4. patients who underwent abdominal surgery within 1 year before signing ICF;
5. patients who planned to undergo surgery at other sites during the study period;
6. Combined with other pain conditions that may confound the evaluation of postoperative pain according to the investigator;
7. Participants with a history of congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency;
8. Previous and/or family history of malignant hyperthermia;
9. Participants with poorly controlled blood pressure during screening (systolic blood pressure ≥160mmHg or ≤90 mmHg while sitting during screening, and/or 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;
10. Heart rate \< 50 beats/min or heart rate \> 100 beats/min 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 \[QTcF=QT/ (RR\^0.33)\]; Or a history of severe arrhythmias such as atrioventricular block of degree II or higher, or cardiac insufficiency;
11. Patients with severe liver, kidney, cardiovascular, cerebrovascular, or metabolic diseases judged by the investigator to be unsuitable for the trial;
12. Patients with advanced malignant tumors who were judged by the investigators to be not suitable for participating in the trial;
13. 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;
14. Patients with skin infection, ulceration or scar constitution around the incision, judged by the investigator to be not suitable for the trial;
15. 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;

Where this trial is running

Changsha, Hunan and 1 other locations

• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• Sichuan Provincial People's Hospital — Sichuan, China (Recruiting)

Study contacts

• Study coordinator: wang, PhD

Conditions Pain After Abdominal Surgery