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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
333
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).
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.
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.
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGSichuan Provincial People's Hospital
Sichuan, China
RECRUITINGArea 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
Time frame: From administration until 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.
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
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 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
The time from the completion of administration to the first morphine rescue analgesic treatment
Time frame: 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
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
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
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
Proportion of participants who used rescue analgesics within 0-4h, 0-6h, 0-12h, 0-24h, 0-48h, and 0-72h after administration
Time frame: From the time of administration to 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after administration
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