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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYH9089 injection | Experimental |
| |
| Ropivacaine hydrochloride | Active Comparator |
| |
| 0.9 % sodium chloride | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYH9089 injection | Drug | Before the surgical incision was closed, SYH9089 injection was applied to the incision wound. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Profile | Participants with an Adverse Event through 14 days | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 to 120 hours |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients with a history of hypersensitivity to the investigational drug, comparator drug, surgical anesthetics, rescue analgesic drugs, or other drugs that may be used during the trial; 2. Patients with a history of drug abuse/substance use, or those with positive results on a drug abuse screening; 3. Patients with neurological/psychiatric, respiratory, endocrine, hematologic, musculoskeletal, gastrointestinal, cardiovascular systems, or hepatic/renal diseases, judged by the investigator to be unsuitable for the trial; 4. Patients with a history of diabetes mellitus; 5. Patients with a history of myocardial infarction or unstable angina within 1 year prior to randomization; 6. Patients scheduled to undergo purely diagnostic exploratory surgery or palliative tumor resection, judged by the investigator to be unsuitable for the trial; 7. Patients with advanced malignant tumors with extensive metastasis during the screening period, judged by the investigator to be unsuitable for the trial; 8. Combined with other pain conditions that may confound the evaluation of postoperative pain according to the investigator; 9. Patients with a history of severe or refractory postoperative nausea or vomiting; 10. Use of the following drugs for less than 5 half-lives before randomization (based on the actual drug instructions; or within 7 days prior to randomization if the half-life is unclear) which, in the investigator's judgement, may affect the evaluation of analgesic efficacy. These include, but are not limited to: narcotics (opioids), local anesthetics, non-steroidal anti-inflammatory drugs (NSAIDs), sedative-hypnotics, non-benzodiazepines, sedative anesthetics, glucocorticoids (except for topical use), antiepileptics, anxiolytics, antidepressants, as well as Chinese herbal medicines or proprietary Chinese medicines with sedative or analgesic effects; 11. Use of strong CYP1A2 inhibitors for less than 5 half-lives before randomization (e.g., atazanavir, ciprofloxacin, enoxacin, fluvoxamine, ethinylestradiol) ; 12. Subjects with abnormal findings during the screening period (prior to admission) in vital signs, physical examination, 12-lead ECG, or laboratory tests, which in the investigator's judgement make the subject unsuitable for participation in this trial, including:
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This is a randomized, double-blind, parallel-group, dose-escalation study. Sixty subjects scheduled for abdominal surgery will be enrolled and equally allocated to 5 dose groups (12 subjects per group). Within each group, subjects will be randomly assigned in a 4:1:1 ratio to receive SYH9089, active comparator, or placebo.
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| Ropivacaine hydrochloride | Drug | Before the surgical incision was closed, 0.5% ropivacaine hydrochloride was injected into the incision wound, and a total of 20mL was given. |
|
| 0.9 % sodium chloride | Drug | Before the surgical incision was closed, the incision wound was infiltrated with 0.9% sodium chloride injection. |
|
| 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. | 0 to 120 hours |
| 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. | 0 to 120 hours |
| 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. | 0 to 120 hours |
| Proportion of participants with an NRS-A score ≤ 1 at different time points. | Proportion of participants with an NRS-A score ≤ 1 at 6 h, 12 h, 24 h, 48 h, 72 h, 96 h, and 120 h after administration. | 0 to 120 hours |
| Proportion of participants with an NRS-R score ≤ 1 at different time points. | Proportion of participants with an NRS-R score ≤ 1 at 6 h, 12 h, 24 h, 48 h, 72 h, 96 h, and 120 h after administration. | 0 to 120 hours |
| Time of first morphine rescue analgesia | The time from administration to the first morphine rescue analgesic treatment | 0 to 120 hours |
| Maximum pain score at each dressing change | Maximum pain score at each dressing change at 24 h, 48 h, and 72 h after administration. | 0 to 72 hours |
| Participant's Analgesic Satisfaction Score | Participant satisfaction will be assessed at 120 hours after administration. | 0 to 120 hours |
| Investigator Satisfaction Score | Investigator satisfaction will be assessed at 120 hours after administration | 0 to 120 hours |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| 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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