Pain
Conditions
Interventions
RF16001 low dose group:Local infiltration of 430mg RF16001
A local infiltration injection of 430mg RF16001 was performed:Local infiltration of 510mg RF16001
Positive control group:Local infiltration with ropivacaine
Placebo control group:Local infiltration with normal saline
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age of 18-80 years old (including the boundary value), regardless of gender; 2) unilateral total hip arthroplasty under general anesthesia; PCIA was expected to be needed 72 hours after surgery. 3) American Society of Anesthesiologists (ASA) grade I-II; 4) body weight >=50.0kg for men, >=45.0kg for women, and 18.0 kg/m^2<= body mass index (BMI) <=30.0 kg/m2; 5) Understand the nature, significance, possible benefits, possible inconvenience and potential risks of the trial in detail, understand the research procedure, and sign the informed consent form in person before the trial; 6) The subjects could understand the study process and use the various scales involved in this study, operate the PCIA equipment, communicate well with the researchers, and complete the study in accordance with the study regulations.
Exclusion criteria
Exclusion criteria: 1. Had undergone ipsilateral hip surgery within 1 year before randomization, had undergone contralateral hip surgery within 3 months before randomization, and planned unilateral hip revision surgery; 2. Skin infection, ulceration or scar constitution around the surgical incision, etc. judged by the investigator to be unsuitable for participation in the trial; 3. A history of severe or refractory postoperative nausea or vomiting; 4. History of myocardial infarction, unstable angina pectoris, severe arrhythmia such as atrioventricular block degree II or above, and cardiac insufficiency within the past year or currently; The investigators judged that they should not participate in the trial. 5. History of ischemic stroke or transient ischemic attack, psychiatric history (e.g., schizophrenia, depression, etc.), cognitive impairment, epilepsy, and other diseases or medical history deemed by the investigator to be unsuitable for the trial within the past year or currently; 6. Patients who underwent total hip arthroplasty due to developmental dysplasia of the hip ?-IV (Crowe classification in the Appendix), femoral neck fracture and/or intertrochanteric fracture, proximal femur, or white tumor of the hip were considered by the investigator to be ineligible for the study; 7. Combined with other pain conditions that may confuse the evaluation of postoperative pain by the investigator, the investigator judged that it was not suitable for participating in this study; Patients who planned to undergo surgery at other sites during the study period; 8. Patients with known history of anesthesia accident or any component of the investigational drug, protocol-defined intraoperative medication, allergy or contraindication to rescue drugs and similar drugs, past history and/or family history of malignant high fever; 9. Use of any of the following drugs before randomization, except those permitted under the protocol: (1) within the 5 half-lives before randomization (subject to the actual drug instructions, the half-life is unknown, and the elution is according to 48h), including but not limited to: "Class III antiarrhythmic drugs, glucocorticoids (intravenous or intra-joint injection), sedative-hypnotics, anxiolytic drugs, antidepressants, strong inhibitors of CYP1A2 enzyme (such as ciprofloxacin, enoxacin, eparylestradiol, fluvoxamine), CYP1A2 enzyme inducers (such as esomeprazole, insulin, phenobarbital), strong inhibitors of CYP3A4 enzyme (such as Voritoxin). Conazole, ketoconazole, ritonavir, clarithromycin), strong CYP3A4 enzyme inducers (such as rifampicin), sedative drugs (except those used according to the protocol), analgesic drugs (any opioid, non-opioid, local anesthetic, etc.; Except if used in accordance with programme provisions); (2) successful use of Chinese herbal medicine with definite analgesic effect assessed by researchers from 7 days before signing ICF to randomization; (3) use of central alpha-adrenergic agonists (e.g., clonidine) or anticonvulsants (e.g., pregabalin or gabapentin) within 14 days before randomization; 10. QTc > 450ms in men and QTc > 470ms in women during the screening period; Patients with pulse 100 beats/min (excluding abnormal heart rate during anesthesia), or refractory hypertension (systolic blood pressure >=140mmHg and/or diastolic blood pressure =90mmHg after use of three different types of antihypertensive drugs during screening, excluding abnormal blood pressure during anesthesia), a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total dosage of morphine; | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS Pain score;Area under the pain intensity score-time curve;The time of first use of patient-controlled analgesia (PCIA);Time to first rescue medication;Cumulative number of morphine rescue uses;Proportion of subjects on rescue medication;Patient and investigator satisfaction;Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactWen Ouyang / Saiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed