Postoperative pain
Conditions
Interventions
Group 1:80 mg/2.4 mg QP002 or 0.25% bupivacaine hydrochloride injection 75 mg
Group 2:160 mg/4.8 mg QP002 or 0.25% bupivacaine hydrochloride injection 75 mg
Group 3:240 mg/7.2 mg QP002 or 0.25% bupivacaine hydrochloride injection 75 mg
Group 4:320 mg/9.6 mg QP002 or 0.25% bupivacaine hydrochloride injection 75 mg
Group 5:400 mg/12.0 mg QP002 or 0.25% bupivacaine hydrochloride injection 75 mg
Sponsors
Sichuan Provincial Academy of Medical Sciences and Sichuan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully informed of the purpose, nature, methods and possible adverse reactions of the study and are willing to participate in the study and sign the informed consent document prior to any procedure; 2. Is scheduled to undergo a unilateral open inguinal herniorrhaphy under general anesthesia with tension-free hernia repair for oblique or straight hernia; 3. Be American Society of Anesthesiology (ASA) physical Class 1 or 2; 4. Age 18 – 75 years (inclusive), male and female subjects; 5. Body mass index (BMI) is between 18.0 and 30 kg/m2 (inclusive); body weight of male subjects is not less than 50 kg, and body weight of female subjects is not less than 45 kg; 6. Ability to well communicate with the Investigator as well as understand the requirements of this study, the usage of NRS pain scales.
Exclusion criteria
Exclusion criteria: 1. Have allergy/hypersensitivity history to bupivacaine and other amide local anesthetics, meloxicam and other NASIDs, or any of the excipients; subjects with a history of severe allergies at the discretion of Investigator; 2. Have chronic and serious cardiovascular, liver, kidney, respiratory, blood, lymphatic, endocrine, immune, nervous, gastrointestinal and other systemic diseases that judged by Investigator to be unsuitable for this study; 3. Subjects with high bleeding risk, including congenital bleeding disorders (such as hemophilia), abnormal platelet function (such as idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital abnormal platelet function) or patients with clinical Any significant active bleeding (except active bleeding due to the expected surgical lesion), or active bleeding disease complicated with peptic ulcer, perforation, etc. within 6 months before randomization, may be aggravated by taking NSAIDs, Those who are not suitable to participate in the trial after evaluation by the investigator; 4. Subjects with a history of myocardial infarction or coronary artery bypass grafting within 1 year before randomization; or with a history of ipsilateral inguinal hernia repair; 5. Have planned to receive surgery during the study, or have a planned concurrent surgical procedure (e.g., bilateral herniorrhaphy); 6. Combined with other pain that may confound postoperative pain evaluation as judged by the investigator; 7. Subjects with cerebral ischemic disease, seizures and other central nervous system diseases, which were judged to affect the efficacy evaluation of Investigational products; 8. Have known malignancies with extensive metastases; 9. Drugs that were used within 5 half-lives before randomization (according to the actual drug instructions, 7 days before randomization if the half-life was unclear) and were judged to affect the analgesic effect by the investigator, including but not limited to : opioids, local anesthetics (including bupivacaine), NSAIDs, glucocorticoids (except aerosol inhalation and topical application), monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), 5-HT and NE reuptake inhibitors (SNRIs) and other antidepressants, antiepileptic and anticonvulsant drugs such as gabapentin and pregabalin, etc. Thiopental sodium, nitrazepam and other sedatives and hypnotics, clonidine and other a2 adrenoceptor agonists (The details are shown in Table 5) 10. Have taken any Chinese traditional medicine, and were judged to affect the analgesic effect by the investigator prior to the randomization; 11. Received any inducers, inhibitors or substrate of CYP3A or CYP2C9 within 5 half-lives (according to the actual drug instructions, 7 days before randomization if the half-life was unclear) prior to the randomization (The details are shown in Table 6); 12. Have a history of glucose-6-phosphate dehydrogenase deficiency; 13. Received investigational products or device in another clinical study within 1 month prior to the randomization; 14. Have blood donation or have blood loss of more than 400 mL, or subjects who received blood transfusions or used blood products within 3 months prior to the randomization; 15. Have abnormal results of vital signs, physical examination, 12-lead ECG and laboratory tests during screening, and determined to be clinically significant by the Investigator, including: a) Vital signs: body temperature, pulse rate ( 100 beats/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS pain intensity scale;Total morphine consumption; | — |
Countries
China
Contacts
Public ContactMengchang Yang
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Outcome results
None listed