Postoperative pain
Conditions
Interventions
Group 1:Low dose of QP-6211
Group 2:High doses of QP-6211
Group 4:Bupivacaine hydrochloride injection
Sponsors
Beijing Jishuitan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully understand the purpose, nature, methods and possible adverse reactions of this study, voluntarily participate in this trial and sign the informed consent form; 2. Patients undergoing open unilateral hallux valgus corrective surgery under spinal anesthesia (planning to perform first metatarsal and/or phalangeal bone osteotomy and/or first metatarsophalangeal joint fusion), with an estimated operation duration of 0.5 hours to 1.5 hours (including the threshold value), and an expected total length of the surgical incision >= 3.5 cm; 3. Subjects with American Society of Anesthesiologists (ASA) classification of I-II; 4. 18 <= age < 75 years old, gender not limited; 5. Body mass index (BMI) between 18.0 and 30.0 kg/m^2 (including 18.0 and 30.0 kg/m^2), male subjects have a weight of no less than 50 kg, and female subjects have a weight of no less than 45 kg; 6. Able to communicate well with the researcher, understand the requirements of this trial and the use of the NRS pain scale and the subject satisfaction rating scale.
Exclusion criteria
Exclusion criteria: 1. Have a history of allergy or contraindication to ropivacaine and its amide-type local anesthetics or to any excipients of QP-6211; 2. Have severe cardiovascular, hepatic, renal, respiratory, hematological, lymphatic, endocrine, immune, nervous, mental, gastrointestinal and other systemic diseases, and have been judged by the investigator to be unsuitable for participating in this trial; 3. Within the 1-year period before randomization, have any of the following diseases or conditions: heart failure (NYHA classification of grade III or IV), angina pectoris, history of myocardial infarction, pulmonary heart disease, severe arrhythmia; 4. Subjects with a history of ipsilateral hallux valgus corrective surgery; 5. Have other diseases, deformities, traumas, etc. in the foot, and have been judged by the investigator to be unsuitable for participating in this trial; 6. Subjects who have had contralateral hallux valgus corrective surgery within the 1 month before randomization, and/or plan to undergo other surgical procedures (such as bilateral hallux valgus corrective surgery, polydactyly corrective surgery) during the trial period; 7. Subjects with other pain conditions, and have been judged by the investigator to potentially confuse postoperative pain evaluation; 8. Subjects with central nervous system and mental system diseases such as cerebral ischemia, epilepsy attacks, and have been judged by the investigator to affect the evaluation of the efficacy of the trial drug; 9. Subjects who have used other drugs that are judged by the investigator to affect the evaluation of analgesic efficacy within the 5 half-lives before randomization (based on the actual drug instructions, or 7 days before randomization if the half-life is unclear), including: opioid drugs, local anesthetics (including bupivacaine), NSAIDs, corticosteroids (except for aerosol inhalation and local application), monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), 5-HT and NE reuptake inhibitors (SNRIs) and other antidepressants, gabapentin, pregabalin, thiopental sodium, nitrazepam, and other analgesics (such as clonidine); 10. Within the 5 half-lives before randomization, have used drugs that affect liver metabolism: strong CYP1A2 inhibitors (such as ciprofloxacin, enoxacin, fluvoxamine); 11. Abnormal vital signs, physical examination, 12-lead electrocardiogram, laboratory test results during the screening period, including: a) Subjects with poor blood pressure control after drug treatment: systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg; or systolic blood pressure upper limit of normal (ULN) by 3 seconds and/or activated partial thromboplastin time (APTT) > ULN by 10 seconds; c) Liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >= 3x ULN; total bilirubin (TBIL) >= 2x ULN; albumin (ALB) = 1.5x ULN; e) Electrocardiogram: male QTcF >= 450 msec, female QTcF >= 470 msec (calculated by Fridericia formula, QTcF = QT/(RR^0.33)); f) Platelet count (PLT) 11.1 mmol/L. 12. Positive human immunodeficiency virus antibody (HIV-Ab) and/or syphilis spirochete antibody (TP-Ab); 13. Female subjects with positive pregnancy test results or who are breastfeeding; fertile subjects who have a fertilit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC) of Numerical Rating Scale–Rest (NRS-R) pain intensity scores at different time intervals after drug administration: AUC???, AUC????, AUC????, AUC????, AUC????, AUC?????, and AUC?????.;Area under the curve (AUC) of Numerical Rating Scale–Activity (NRS-A) pain intensity scores at different time intervals after drug administration: AUC???, AUC????, AUC????, AUC????, AUC????, AUC?????, and AUC?????.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total morphine consumption;PK parameters; | — |
Countries
China
Contacts
Public ContactXieyuan Jiang
Capital Medical University Affiliated Beijing Jishuitan Hospital
Outcome results
None listed