This is a randomized, double-blind, active drug- and placebo-controlled, dose-escalation clinical study conducted in patients scheduled to undergo abdominal surgery. It aims to evaluate the tolerability, safety, pharmacokinetics, and efficacy of SYH9089 Injection for postoperative analgesia in these patients.
1. 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; 2. 18 years old ≤ age ≤75 years old, regardless of gender; 3. 19.0kg/m2≤BMI≤28.0kg/m2, ≥50.0kg for men and ≥45.0kg for women; 4. American Society of Anesthesiologists (ASA) grade I-II; 5. 5. Elective abdominal surgery under general anesthesia, and the length of the main incision is expected to be between 5-9cm (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.
Patientss with poorly controlled blood pressure despite medication: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg; or systolic blood pressure <90 mmHg;
12-lead ECG: QTcF ≥450 ms for males or ≥470 ms for females, or a history of severe arrhythmias such as second-degree type II or higher atrioventricular block, or a history of cardiac insufficiency;
Coagulation function: PT > ULN + 3 seconds and/or APTT > ULN + 10 seconds;
Liver function: ALT and/or AST ≥ 2 × ULN; TBIL ≥ 1.5 × ULN; ALB < 30 g/L;
Parallel
SYH9089 injection
DrugBefore the surgical incision was closed, SYH9089 injection was applied to the incision wound.
Ropivacaine hydrochloride
DrugBefore the surgical incision was closed, 0.5% ropivacaine hydrochloride was injected into the incision wound.
0.9 % sodium chloride
DrugBefore the surgical incision was closed, the incision wound was infiltrated with 0.9% sodium chloride injection.
Adverse Event Profile
Participants with an Adverse Event through 14 days
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores
The AUC of NRS-R during 0-6 h，0-12 h，0-24 h，0-48 h，0-72 h，0-96 h，0-120 h，24-48 h，48-72 h，24-72 h，72-96 h，and 96-120 h after administration. Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain.
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores
The AUC of NRS-A during 0-6 h，0-12 h，0-24 h，0-48 h，0-72 h，0-96 h，0-120 h，24-48 h，48-72 h，24-72 h，72-96 h，and 96-120 h after administration. Pain intensity was assessed on a scale of 0 to 10, where 0=no pain and 10=worst possible pain.
Cumulative use of rescue analgesics during each period
Cumulative amount of rescue analgesics used during 0-6 h，0-12 h，0-24 h，0-48 h，0-72 h，0-96 h，0-120 h，24-48 h，48-72 h，24-72 h，72-96 h，and 96-120 h after administration.
Proportion of participants not requiring rescue analgesia in each period
Proportion of participants not requiring rescue analgesia within 0-6 h，0-12 h，0-24 h，0-48 h，0-72 h，0-96 h，0-120 h，24-48 h，48-72 h，24-72 h，72-96 h，and 96-120 h after administration.
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