A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Profile of TRD303 for Postoperative Analgesia After Abdominal Surgery in China.

NCT07353307 | Recruiting Phase 3 DMC

• 1 other identifier: TRD303-Ⅲ -02
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  From administration until 72 hours after administration

Secondary Outcomes (6)

• Area under the pain intensity time curve at rest

  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

  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

  From administration until 72 hours after administration

• Cumulative use of rescue analgesics during each period

  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

  From the time of administration to 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after administration

Other Outcomes (3)

• Maximum Plasma Concentration (Cmax) of TRD303

  From administration until 72 hours after administration

• Area under curve (AUC) of the plasma concentration-time during 0-t (t=0 to 48h)

  From administration until time t (t=0 to 48h) after administration

• Area under curve (AUC) of the plasma concentration-time during 0-∞ (AUC0-∞)

  From administration until 7 days post-administration, continuing until all prototype drugs were completely eliminated.

Study Arms (3)

TRD303 group

EXPERIMENTAL

Before the surgical incision was closed, TRD303 solution was applied to the incision wound.

Drug: TRD303 solution

Positive control group

ACTIVE COMPARATOR

Before the surgical incision was closed, 0.5% ropivacaine hydrochloride was injected into the incision wound

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

Drug: 0.9 % sodium chloride

Interventions

TRD303 solution DRUG

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).

Also known as: Before the surgical incision was closed, TRD303 solution was applied to the incision wound.

TRD303 group

Ropivacaine hydrochloride DRUG

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.

Positive control group

0.9 % sodium chloride DRUG

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.

Placebo control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;
• \. 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (2)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Sichuan Provincial People's Hospital

Sichuan, China

RECRUITING

MeSH Terms

Interventions

Ropivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

wang, PhD

CONTACT

+86073188618152; zwyhyll@163.com

yang, PhD

CONTACT

ymc681@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 20, 2026
• Study Start: December 30, 2025
• Primary Completion: March 18, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)