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RECRUITING
NCT07353307
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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).

DRUG

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.

DRUG

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