Postoperative pain
Conditions
Interventions
Group 1:80 mg/2.4 mg QP002
Group 2:160 mg/4.8 mg QP002
Group 3:0.9% sodium chloride injection 90 mg
Group 4:0.25% bupivacaine hydrochloride injection 50 mg
Sponsors
Beijing Jishuitan 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 open unilateral hallux valgus surgery (distal first metatarsal osteotomy and soft tissue release) under spinal anesthesia, the expected operation time is between 0.5 hour and 1.5 hours (including the critical value), and the expected total length of surgical incision is >= 3.5 cm. 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 and Subject satisfaction rating 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), 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 prior to the 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 any of the following conditions within 1 year prior to the randomization: heart failure (NYHA class III or IV), angina pectoris, previous myocardial infarction, pulmonary heart disease, severe arrhythmia, uncontrolled asthma (>= 1 acute exacerbation in a week), or a history of coronary artery bypass grafting; 5. Subjects with a history of ipsilateral hallux valgus surgery; 6. Combined with other foot diseases, deformities, trauma, etc., and not suitable for this study as judged by the investigators; 7. Subjects with a history of contralateral hallux valgus surgery within 3 months prior to the randomization, or have planned to receive surgery during the study, or have a planned concurrent surgical procedure (e.g., bilateral hallux valgus surgery, first metatarsophalangeal arthrodesis); 8. Combined with other pain that may confound postoperative pain evaluation as judged by the investigator; 9. Subjects with cerebral ischemic disease, seizures and other central nervous system diseases, which were judged to affect the efficacy evaluation of Investigational products; 10. Drugs which were judged to affect the analgesic effect by the investigator were used within 5 half-lives prior to the randomization (according to the actual drug instructions, 7 days prior to the randomization if the half-life was unclear), 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 (The details are shown in Table 5); 11. Have taken any Chinese traditional medicine within 7 days prior to the randomization, and were judged to affect the analgesic effect by the investigator; 12. 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: (1) Vital signs: body temperature, pulse rate ( 100 beats/min), respiration rate, and blood pressure(hypertensive subjects who have not received regular antihypertensive therapy or have poor control of blood pressure : sitting systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg during screening period, or sitting systolic blood pressure < 90 mmHg) during screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS pain intensity scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total morphine consumption;PK parameters; | — |
Countries
China
Contacts
Public ContactXieyuan Jiang, Xu Hui
Beijing Jishuitan Hospital
Outcome results
None listed