New wound gel could ease pain after belly surgery
NCT ID NCT07353307
First seen Jun 25, 2026 · Last updated Jul 21, 2026 · Updated 3 times
Summary
This phase 3 trial tests a solution called TRD303, applied directly to the surgical wound during closure, to see if it reduces pain after abdominal surgery. About 333 adults having elective abdominal surgery will participate. The study measures pain intensity over 72 hours and checks for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TRD303 solution (applied to the surgical wound during closure)
- What this could lead to
- If successful, this could provide a new, effective option for managing pain after abdominal surgery, potentially reducing the need for strong painkillers.
- What could go wrong
- This is a phase 3 trial, but results may not apply to all surgeries or patients. The solution may not work better than existing treatments, and there could be side effects like infection or allergic reaction.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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333 people
The number who actually took part.
- Started
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Dec 2025
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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;
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sichuan Provincial People's Hospital
Sichuan, China
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The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
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