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.
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;
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;
Parallel
TRD303 solution
DrugAfter 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
DrugAfter 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
DrugAfter 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.
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
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.
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.
Time of first morphine rescue analgesia
The time from the completion of administration to the first morphine rescue analgesic treatment
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
Maximum Plasma Concentration (Cmax) of TRD303
Maximum plasma concentration of TRD303 after Administration
Area under curve (AUC) of the plasma concentration-time during 0-t (t=0 to 48h)
The area under the drug concentration-time curve from the start of drug administration to time t (AUC0-t, t=0 to 48h)
Area under curve (AUC) of the plasma concentration-time during 0-∞ (AUC0-∞)
Total area under the curve from administration until all the prototypic drugs were eliminated (AUC0-∞)
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