A Phase # Clinical Study Trial of Felbinac Trometamol Injection in China

Study Overview
=================
Brief Summary
-----------------
A multi-center, randomized, double-blind, placebo parallel controlled phase Ⅲ clinical trial on the efficacy and safety of felbinac trometamol Injection in the treatment of postoperative pain in gynecology.main purpose is to evaluate the efficacy of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.Secondary purpose is to evaluation the safety of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Placebo Parallel Controlled Phase Ⅲ Clinical Trial on the Efficacy and Safety of Felbinac Trometamol Injection in the Treatment of Postoperative Pain in Gynecology

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Felbinac Trometamol Injection
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18≤age≤65 years of age, gender is not limited; ASA grade I or II; 18 ≤ body mass index (BMI) ≤ 30 [BMI = weight (kg) / height 2 (m2)]; Patients who intend to undergo laparotomy or laparoscopic total or subtotal hysterectomy (with or without salpingectomy and oophorectomy) under elective general anesthesia; Expected hospital stay ≥48 hours after surgery； Expected to require more than 24 hours of PCIA (patient controlled intravenous analgesia) treatment after surgery; Ability to understand research procedures and pain scales, operate PCIA devices, and communicate effectively with investigators; Agree to participate in the trial and voluntarily sign the informed consent form. Exclusion Criteria: Except for the chronic pain caused by the target lesion of this operation, those who have a history of chronic pain for more than 3 months or who are undergoing regular analgesia for more than 3 months; Those who have used barbiturates within 20 days before surgery, those who used other analgesics, muscle relaxants or sedatives within 24 hours before operation (excluding those required for this operation), or those who used long-acting non-steroidal anti-inflammatory drugs (NSAIDs) within 12 hours, or those who used short-acting non-steroidal anti-inflammatory drugs (NSAIDs) within 6 hours before operation. A person with high bleeding risk, and also including who with congenital bleeding disorders (such as hemophilia), thrombocytopenia (PLT < 80 × 10 ∧ 9 / L), abnormal platelet function (such as idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet dysfunction, etc.) or any clinically significant active bleeding, coagulopathy; A person who received full-dose anticoagulant therapy, activated protein C or thrombolytic drugs within 6 hours before surgery (except for heparin subcutaneous injection for preventive treatment); People with heart failure (NYHA grade III or IV), unstable angina pectoris, acute myocardial infarction, and severe arrhythmia within 6 months before surgery Hypertensive patients who have not been satisfactorily controlled by blood pressure (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥105mmHg), or ACEI/diuretics for ≥30 days, or hypotension (systolic blood pressure <90mmHg); People with pulmonary fibrosis bronchial asthma, pulmonary heart disease or other serious respiratory diseases that are not the purpose of this treatment; Person with gastrointestinal ulcer and a history of gastrointestinal bleeding within 6 months before operation and required medical treatment(prophylactic medication or undiagnosed persons are not excluded); Those with previous cerebral arteriovenous malformations, cerebral aneurysms, brain tumors, or preoperative traumatic brain injury, intracranial surgery, history of stroke; Patients with poor glycemic control of diabetes (random blood glucose > 11.1mmol / L); Patients with autoimmune diseases, connective tissue diseases, etc. who need long-term use of adrenocortical hormone therapy; Abnormal liver and kidney function: ALT/AST> 2 times the upper limit of normal value, or creatinine> upper limit of normal value, or dialysis treatment within 28 days before surgery; Known to be allergic to multiple drugs in the past, or allergic to the components of this drug, NSAIDs, opioids; Patients who are afflicted with narcotic drugs, drugs, or resistant to opioids; History of alcohol abuse within one year prior to screening Those who have participated in other clinical trials within 3 months before surgery; Investigators believe that it is not suitable for participating in this research.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group1<br>Generic name: Felbinac Trometamol Injection; Dosage form: Injection Dosage:94.25mg Volume:4ml Frequency:Multi-dose Duration:1 day. A total of 132 subjects received the test drug . | Drug: Felbinac Trometamol Injection<br>* Felbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min).. One dose at 8h and 16h after the start of the first dose,the first intravenous infusion was started at 30±5 minutes before the end of the operation (Skin suture completes the last stitch).The drug was given 3 times,3 times/day, once every 8 hours.<br>* Other names: 4-Biphenylacetic Acid Trishydroxymettiylaminometnane;|
| Placebo Comparator: group2<br>Placebo:Normal saline Dosage form:Injection Dosage:0mg Volume:0ml Frequency:Multi-dose Duration:1 day A total of 132 subjects received the placebo. | Drug: Placebos<br>* Placebo diluted to 100 ml with 0.9% sodium chloride injection. Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min). One dose at 8h and 16h after the start of the first dose, the first intravenous infusion was started at 30±5 minutes before the end of the operation (Skin suture completes the last stitch).The drug was given 3 times,3 times/day, once every 8 hours.<br>* Other names: Normal saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hours (h) total morphine consumption | The total amount of morphine within 24 hours after the end of first drug administration | up to 24 hours after multi-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the pain intensity curve during movement (AUCM) | Pain intensity under movement Pain intensity under movement | 1-8 hours (h) ，8-16 h，16-24 (within 24 hours after the end of first drug administration） | 
| Area under the pain intensity curve during rest(AUCR) | Pain intensity under rest | 1-8 hours (h) ，8-16 h，16-24 h（within 24 hours after the end of first drug administration） | 
| Press time | The first time to press the analgesic pump for analgesia | up to 24 hours after multi-dose | 
| Total and effective pressing times of analgesic pump within 24 hours after the first administration | Total and effective pressing times of analgesic pump within 24 hours after the first administration | up to 24 hours after multi-dose | 
| The proportion of morphine used to remedy analgesia. | The proportion of morphine used to remedy analgesia. | up to 24 hours after multi-dose |