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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRD303 group | Experimental | Before the surgical incision was closed, TRD303 solution was applied to the incision wound. |
|
| Positive control group | Active Comparator | Before the surgical incision was closed, 0.5% ropivacaine hydrochloride was injected into the incision wound |
|
| Placebo control group | Placebo Comparator | Before the surgical incision was closed, the incision wound was infiltrated with 0.9% sodium chloride injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of TRD303 | Maximum plasma concentration of TRD303 after Administration | From administration until 72 hours after administration |
| Area under curve (AUC) of the plasma concentration-time during 0-t (t=0 to 48h) |
Inclusion Criteria:
4. 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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wang, PhD | Contact | +86073188618152 | zwyhyll@163.com | |
| yang, PhD | Contact | ymc681@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
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| 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. |
|
| 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. |
|
| 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. | 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 | 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 | 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 | 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 | From the time of administration to 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after administration |
The area under the drug concentration-time curve from the start of drug administration to time t (AUC0-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-∞) | Total area under the curve from administration until all the prototypic drugs were eliminated (AUC0-∞) | From administration until 7 days post-administration, continuing until all prototype drugs were completely eliminated. |
| Sichuan Provincial People's Hospital | Recruiting | Sichuan | China |
|
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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