Postoperative pain
Conditions
Interventions
Experimental Group 1:Local infiltration was given 200mg of SYH9089
Experimental Group 2:Local infiltration was given 440mg of SYH9089
Experimental Group 3:Local infiltration was given 560mg of SYH9089
Experimental Group 4:Local infiltration was given 680mg of SYH9089
Experimental Group 5:Local infiltration was given 800mg of SYH9089
Placebo group:0.9% sodium chloride injection was given for local infiltration
Positive control group:Local infiltration was given 100 mg of 0.5% ropivacaine hydrochloride injection
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent; 2. Male and female, 18 years old =45.0 kg (female) or >=50.0 kg (male), BMI in the range of 19.0-28.0 kg/m^2 (including the cut-off value); 4. Abdominal surgery is planned under general anesthesia, and the anesthesia protocol specified in the protocol can be used. The size of the surgical incision is expected to be about 8 cm-10 cm (including the cut-off value), with at least one incision >=5 cm in length; 5. American Society of Anesthesiologists (ASA) grade I-II; 6. Able to communicate well with investigators and understand the requirements of this trial and the use of NRS pain scale and subject satisfaction rating scale.
Exclusion criteria
Exclusion criteria: Subjects could not participate in the study if they met any of the following conditions: Previous and coexisting diseases 1) Subjects with a history of allergy to investigational drugs, control drugs, surgical anesthetics, rescue analgesics, or similar drugs; 2) Previous history of drug abuse/drug use or screening positive for drug abuse (including benzodiazepine, methamphetamine, cocaine, morphine, ketamine, THC); 3) Combined with neurological/psychiatric, respiratory, endocrine, hematological, musculoskeletal, gastrointestinal, cardiovascular, liver and kidney diseases and other systemic diseases judged by the investigator to be not suitable for participation in the trial; 4) Diabetic patients; 5) History of myocardial infarction or unstable angina within 1 year before randomization; 6) Subjects who are planning to undergo exploratory diagnostic surgery or palliative tumor resection but are not suitable for the trial according to the investigator's judgment; 7) Subjects with advanced malignant tumors with extensive metastasis during the screening period who are judged by the investigator to be unsuitable for the trial; 8) Subjects with other pain that the investigator judged could confound the postoperative pain assessment; 9) A history of severe or refractory postoperative nausea or vomiting; Concomitant Drugs 10) Subjects who used drugs that were judged by the investigator to affect the evaluation of analgesic efficacy in the five half-lives before randomization (based on the actual drug instructions, or 7 days before randomization if the half-lives were unclear), including but not limited to: Opioids, local anesthetics, non-steroidal anti-inflammatory drugs, sedative hypnotics (benzodiazepines), non-benzodiazepines, sedative anesthetics, glucocorticoids (except for local topical use), antiepileptic drugs, anxiolytic drugs, antidepressant drugs and Chinese herbal medicine or patent Chinese medicine with sedative and analgesic effects; 11) Use of strong CYP1A2 inhibitors (e.g., azanavir, ciprofloxacin, enoxacin, fluvoxamine, ethinyl estradiol, etc.) within 5 half-life periods before randomization; Laboratory and other tests 12) Abnormal vital signs, physical examination, 12-lead electrocardiogram, and laboratory test results during screening (before admission) that were judged by the investigator to be ineligible for the trial, including: a. Subjects whose blood pressure is poorly controlled with medical therapy: systolic blood pressure >=160mmHg and/or diastolic blood pressure >=100mmHg; Or systolic blood pressure =450ms in male or >=470ms in female, or a history of severe arrhythmia such as atrioventricular block of degree II or above, or a history of cardiac insufficiency; c. Coagulation function: PT>ULN+3 seconds and/or APTT>ULN+10 seconds; d. Liver function: ALT and/or AST>=2×ULN; TBIL>=1.5×ULN; ALB=1.5×ULN; f. Platelet count 11.1mmol/L. 13)HBsAg or HCV-Ab or HIV-Ab positive or TP-Ab positive; 14) Female subjects with a positive pregnancy test or who are breastfeeding; Subjects of childbearing potential had plans to have children, were unwilling or unable to use effective contraception, or had plans to donate sperm or eggs during the trial and within 3 months after the end of the trial drug administration. Other 15) Had a history of drug abuse, drug use and/or alcohol abuse in the 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of SYH9089 in patients undergoing abdominal surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK);NRS pain intensity scale;Area under the curve (AUC) of resting-state pain intensity in different time periods;Area under the curve (AUC) during exercise pain intensity in different time periods;Consumption of opioids;Proportion of subjects who did not use opioids;Time to first use of rescue analgesic;Subjects' overall satisfaction with analgesia was scored;Investigator's overall satisfaction with analgesia; | — |
Countries
China
Contacts
Public ContactWen Ouyang/ Guoping Yang
The Third Xiangya Hospital of Central South University
Outcome results
None listed