Postoperative pain of breast cancer
Conditions
Interventions
Ropivacaine injection group:Ropivacaine hydrochloride injection
Bupivacaine liposome injection group:Bupivacaine liposome injection
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this trial, be able to understand the procedures and methods of this study, strictly follow the clinical trial protocol to complete this trial, and voluntarily sign an informed consent form.; 2. Subjects who undergo elective radical breast surgery under general anesthesia.; 3. Age = 18 years old, gender requirement is female.; 4. The American Society of Anesthesiologists (ASA) grading is from level I to level II.;
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of myocardial infarction or unstable angina within the first 6 months of randomization, or a history of severe arrhythmias such as grade II or above atrioventricular block, or a history of NYHA grade II or above heart function.; 2. Subjects with a history of combined ischemic stroke or transient ischemic attack (TIA).; 3. Subjects with comorbidities of the mental system (such as schizophrenia, depression, etc.) and difficulties in communication;; 4. Merge subjects with other physical or visceral pain that may affect postoperative pain assessment;; 5. Abnormal laboratory test results during the screening period: ? Fasting blood glucose (FPG) = 10.0 mmol/L; ? Abnormal liver function: aspartate aminotransferase (AST) or/and alanine aminotransferase (ALT) and/or total bilirubin (TBIL) = 1.5 × ULN; ? Renal dysfunction: blood creatinine (Cr) = 1.5 × ULN, or dialysis subjects; ? Abnormal coagulation function: PT>upper limit of normal value+3 s and/or APTT>upper limit of normal value+10 s; ? Platelet count (PLT)100 beats/min, 12 lead electrocardiogram QTc interval extension: male = 450 ms, female = 470 ms;; 8. Individuals with a history of allergies to bupivacaine and similar local anesthetics. Combination medication: (1) Known allergies or contraindications to bupivacaine or other amide based local anesthetics, as well as other drugs that may be used during the trial, such as propofol and opioids; (2) Use any of the following drugs within the first 5 drug half-lives (based on the actual drug instructions, if the half-life is unknown, elute for at least 48 hours): ? Drugs that affect liver metabolism: Strong CYP1A2 inhibitors such as ciprofloxacin, enoxacin, and fluvoxamine; CYP1A2 substrates: such as theophylline and promethazine; Strong CYP3A4 inhibitors: such as voriconazole, ketoconazole, ritonavir; CYP3A4 substrates: such as darunavir, indinavir, and saquinavir; Strong CYP3A4 inducers, such as rifampicin; ? Intravenous or oral corticosteroid drugs; ? Sedative drugs: benzodiazepines (such as diazepam, flurazepam, oxazepam, clozapine, triazolam, alprazolam, estazolam, midazolam, etc.), barbiturates, carbamazepine, phenytoin, magnesium sulfate, chloral hydrate, etc; ? Analgesics and other medications: Non steroidal anti-inflammatory drugs (aspirin allowed for the prevention of cardiovascular events, but must be used stably for at least 30 days before randomization, with a daily dose of = 100mg/day), opioid agonists/antagonists, central a Adrenergic agonists (such as clonidine and dexmedetomidine), anticonvulsants (such as carbamazepine, pregabalin, gabapentin), and antidepressants (such as tricyclines and selective 5-HT reuptake inhibitors).;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time for using remedial analgesics;Accumulated usage of remedial analgesics;Chronic pain incidence rate;Adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactZhang Wenzhou
Henan Cancer Hospital
Outcome results
None listed