Pain After Abdominal SurgeryPhase 3NCT07353307
A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Profile of TRD303 for Postoperative Analgesia After Abdominal Surgery in China.
A Phase 3 study testing TRD303 solution, Ropivacaine hydrochloride and 0.9 % sodium chloride in people with Pain After Abdominal Surgery, run by The Third Xiangya Hospital of Central South University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain After Abdominal Surgery
- What is being tested?
- TRD303 solution, Ropivacaine hydrochloride and 0.9 % sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2025to 15 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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.
Who cannot join
- 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;
- 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;
- 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;
- patients who underwent abdominal surgery within 1 year before signing ICF;
- patients who planned to undergo surgery at other sites during the study period;
- Combined with other pain conditions that may confound the evaluation of postoperative pain according to the investigator;
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- Participants with a history of congenital or idiopathic methemoglobinemia or glucose-6-phosphate dehydrogenase deficiency;
- Previous and/or family history of malignant hyperthermia;
- 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;
- 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;
- Patients with severe liver, kidney, cardiovascular, cerebrovascular, or metabolic diseases judged by the investigator to be unsuitable for the trial;
- Patients with advanced malignant tumors who were judged by the investigators to be not suitable for participating in the trial;
- 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;
- Patients with skin infection, ulceration or scar constitution around the incision, judged by the investigator to be not suitable for the trial;
- 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;
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Sichuan Provincial People's Hospital
Sichuan
About this study
Official title: 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
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.
- Conditions
- Pain After Abdominal Surgery
- Being tested
- TRD303 solution, Ropivacaine hydrochloride, 0.9 % sodium chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRD303 solutionDrug
Also called Before the surgical incision was closed, TRD303 solution was applied to the incision wound.
After the peritoneum was sutured, the final irrigation and suction were performed, and the wound was smeered with TRD303 solution after incision injection before the surgical incision was sutured. The injection volume of the main incision was 2.5mL (±0.5mL was allowed according to the actual situation of the incision). For surgery involving multiple incisions, the secondary incisions were administered according to the number of incisions per unit, and the drug administration volume of each incision was 0-0.5 mL (0mL≤ administration volume ≤0.5mL).
Ropivacaine hydrochlorideDrug
After the completion of peritoneal suture, final irrigation and aspiration, 0.5% ropivacaine hydrochloride was injected locally around the incision before the surgical incision was closed. If there was residual drug solution after the administration of the primary incision, the residual drug solution was used to the secondary incision infiltration, and a total of 30mL was given.
0.9 % sodium chlorideDrug
After the suture of the peritoneum, final irrigation and aspiration, 0.9% sodium chloride injection was injected locally around the incision before the suture of the surgical incision. If there was residual drug solution after the administration of the primary incision, the residual drug solution was used to the secondary incision infiltration, and a total of 30mL was given.
| Study group | Role | What they receive |
|---|---|---|
| TRD303 group | Experimental | Before the surgical incision was closed, TRD303 solution was applied to the incision wound. Receives: Drug: TRD303 solution |
| Positive control group | Active comparator | Before the surgical incision was closed, 0.5% ropivacaine hydrochloride was injected into the incision wound Receives: Drug: Ropivacaine hydrochloride |
| Placebo control group | Placebo comparator | Before the surgical incision was closed, the incision wound was infiltrated with 0.9% sodium chloride injection Receives: Drug: 0.9 % sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC) of the pain intensity-time during 0-72h at rest
Area under the resting pain intensity time curve (AUC0-72h) during 0-72 hours after administration
Measured: From administration until 72 hours after administration
Secondary outcomes (6)
Area under the pain intensity time curve at rest
The area under the pain intensity time curve (AUC0-4h, AUC0-6h, AUC0-12h, 0-24h, AUC0-48h, AUC24-48h, AUC48-72h) in resting state during 0-4h, 0-6h, 0-12h, 0-24h, 0-48h, 24-48h, and 48-72h after the completion of administration.
Measured: From administration until 4 hours, 6 hours, 12 hours, 24 hours, 48 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration
Area under the pain intensity time curve during exercise
Area under the pain intensity time curve (AUC0-12h, AUC0-24h, AUC0-48h, AUC0-72h, AUC24-48h, AUC48-72h) during exercise during 0-12h, 0-24h, 0-48h, 0-72h, 24-48h, and 48-72h after the completion of administration.
Measured: From the time of administration to 12 hours, 24 hours, 48 hours, 72 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration
Time of first morphine rescue analgesia
The time from the completion of administration to the first morphine rescue analgesic treatment
Measured: From administration until 72 hours after administration
Cumulative use of rescue analgesics during each period
Cumulative amount of rescue analgesics used during 0-4h, 0-6h, 0-12h, 0-24h, 0-48h, and 0-72h after completion of administration
Measured: From the time of administration to 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after administration
The number of rescue analgesia in each period
The cumulative number of rescue analgesics used during 0-4h, 0-6h, 0-12h, 0-24h, 0-48h, and 0-72h after the completion of administration
Measured: From the time of administration to 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after administration
Proportion of rescue analgesia in each period
Proportion of participants who used rescue analgesics within 0-4h, 0-6h, 0-12h, 0-24h, 0-48h, and 0-72h after administration
Measured: From the time of administration to 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Dec 2025
- Primary completion21 Apr 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingyong Zhou,MD,PhD, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353307
- Sponsor's protocol ID
- TRD303-Ⅲ -02
- Status last verified
- Mar 2026
- First submitted
- 29 Dec 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07353307
- Acronym / sponsor ID
- TRD303-Ⅲ -02
- Conditions
- Pain After Abdominal Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 21 Apr 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRD303 group | Experimental | Drug: TRD303 solutionBefore the surgical incision was closed, TRD303 solution was applied to the incision wound. |
| Positive control group | Active comparator | Drug: Ropivacaine hydrochlorideBefore the surgical incision was closed, 0.5% ropivacaine hydrochloride was injected into the incision wound |
| Placebo control group | Placebo comparator | Drug: 0.9 % sodium chlorideBefore the surgical incision was closed, the incision wound was infiltrated with 0.9% sodium chloride injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
- 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.
Key exclusion criteria (15 listed)
- 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;
- 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;
- 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;
- patients who underwent abdominal surgery within 1 year before signing ICF;
- patients who planned to undergo surgery at other sites during the study period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRD303 solutionAlso: Before the surgical incision was closed, TRD303 solution was applied to the incision wound.After the peritoneum was sutured, the final irrigation and suction were performed, and the wound was smeered with TRD303 solution after incision injection before the surgical incision was sutured. The injection volume of the main incision was 2.5mL (±0.5mL was allowed according to the actual situation of the incision). For surgery involving multiple incisions, the secondary incisions were administered according to the number of incisions per unit, and the drug administration volume of each incision was 0-0.5 mL (0mL≤ administration volume ≤0.5mL). | Drug | TRD303 group |
| Ropivacaine hydrochlorideAfter the completion of peritoneal suture, final irrigation and aspiration, 0.5% ropivacaine hydrochloride was injected locally around the incision before the surgical incision was closed. If there was residual drug solution after the administration of the primary incision, the residual drug solution was used to the secondary incision infiltration, and a total of 30mL was given. | Drug | Positive control group |
| 0.9 % sodium chlorideAfter the suture of the peritoneum, final irrigation and aspiration, 0.9% sodium chloride injection was injected locally around the incision before the suture of the surgical incision. If there was residual drug solution after the administration of the primary incision, the residual drug solution was used to the secondary incision infiltration, and a total of 30mL was given. | Drug | Placebo control group |
Primary outcome
Area under curve (AUC) of the pain intensity-time during 0-72h at rest
Time frame: From administration until 72 hours after administration
Area under the resting pain intensity time curve (AUC0-72h) during 0-72 hours after administration
6 secondary outcomes
Area under the pain intensity time curve at rest
Time frame: From administration until 4 hours, 6 hours, 12 hours, 24 hours, 48 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration
Area under the pain intensity time curve during exercise
Time frame: From the time of administration to 12 hours, 24 hours, 48 hours, 72 hours after administration, from 24 hours to 48 hours after administration, from 48 hours to 72 hours after administration
Time of first morphine rescue analgesia
Time frame: From administration until 72 hours after administration
Cumulative use of rescue analgesics during each period
Time frame: From the time of administration to 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after administration
The number of rescue analgesia in each period
Time frame: From the time of administration to 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after administration
Proportion of rescue analgesia in each period
Time frame: From the time of administration to 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TRD303 solution, Ropivacaine hydrochloride and 0.9 % sodium chloride in people with Pain After Abdominal Surgery, run by The Third Xiangya Hospital of Central South University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve (AUC) of the pain intensity-time during 0-72h at rest (time frame: From administration until 72 hours after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.