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A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Profile of TRD303 for Postoperative Analgesia After Abdominal Surgery in China.
Sponsor: The Third Xiangya Hospital of Central South University
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.
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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
333
Start Date
2025-12-30
Completion Date
2026-12-30
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
TRD303 solution
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 hydrochloride
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 chloride
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.
Locations (2)
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Sichuan Provincial People's Hospital
Sichuan, China