Perioperative pain management
Conditions
Interventions
test group:Perianal injection of bupivacaine liposomes after the operation
Control group:Perianal injection of 0.25% bupivacaine after the operation
Sponsors
Shanxi Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: Patients must meet all the selected standards below to enter the group to study: 1. Age =60 years old, and gender is not limited; 2. Preoperative diagnosis is ? ~ IV degree of internal hemorrhoids, external hemorrhoids, mixed hemorrhoids with lonely hemorrhoids, or perianal abscesses ; 3. Receive the optional intraspinal anesthesia surgery, and the length of surgery is =3h; 4. ASA score is divided into level I ~ III; 5. 18 kg/m2 < BMI <30kg/m2; 6. Before starting any activities related to the trial, voluntary signing the informed consent, fully understand the purpose and significance of this experiment, and voluntarily abide by the test process of this test.
Exclusion criteria
Exclusion criteria: 1. Patients with contraindications to intraspinal anesthesia ; 2. Previous history of ischemic stroke or transient ischemic attack (TIA); 3. Previous history of difficult airways, such as obstructive sleep apnea syndrome; 4. Patients with previous severe respiratory disease (acute respiratory tract infections, acute episode of chronic obstructive pulmonary diseases, uncontrolled asthma, etc.); 5. Within the history of myocardial infarction or unstable angina pectoris within 6 months before the screening, or there is a history of severe arrhythmias such as II and II degree or above, or the history of Class II and above in NYHA heart function grading; 6. In the past, there were mental system diseases (such as schizophrenia, depression, etc.) and cognitive dysfunction, or the history of epilepsy and Parkinson syndrome; 7. Suffer from late malignant tumors or existing malignant tumor subjects; 8. Acquired by those who have not received regular antihypertensive treatment or poor blood pressure control (the screening period systolic blood pressure =160mmHg or =90mmHg, and/or screening period relaxation pressure =100mmHg or =60mmHg); 9. There is a history of drug abuse, drug abuse, and alcoholism within two years before the screening period. Alcoholism, a daily drinking more than 2 units of alcohol (1 unit = 360ml beer or 45ml alcohol with 40%liquor or 150ml wine); 10. Meridity blood oxygen saturation (SPO2) <90% during the screening period ; 11. Poor blood glucose control during the screening: Random blood glucose =11.1mmol/L; 12. During the screening period, liver function abnormalities: AST and/or ALT = 2 times the normal limit or total bilirubin TBIL = 2 times the normal value of the upper limit; Renal function abnormalities in the screening period; blood creatinine (CR ) = 2 times the upper limit of the normal value; 13. Abnormal coagulation function of the screening period: Prolonged prothrombin time (PT) extends the upper limit of the normal value of 3 seconds and/ activated partial thromboplastin time (APTT) extends the upper limit of the normal value of 10 seconds; Screening period anemia or thrombocytopenia: Hb < 70g/L, PLT <100 × 109/L; 14. Patients with allergies or contraindications of anesthetic drugs such as local anesthetics and their drug components in the past; 15. Continuous use of analgesics for any reasons for more than 10 days in the 3 months prior to randomization, or the time between the last dose and the randomization time shorter than the 5-half-life of the drug, including but not limited to the following drugs: selective a2 adrenergic receptor agonists, sedative hypnotic drugs, opioid excitement/antagonists, monoamine oxidase inhibitors, glucocorticoids, antihistamine, antiepileptic, antianxiety, antidepressant and other antipsychotic drugs. 16. Patients who have had perianal surgery in the past; 17. Had participated in other drug clinical trials within 3 months before the screening period. Researchers judged that the subjects were not suitable for this clinical trial due to other circumstances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS score;Mean arterial pressure;Heart rate;The first use time of opioids;5-hydroxytryptamine;Substance P;Norepinephrine;Dopamine; | — |
Secondary
| Measure | Time frame |
|---|---|
| High-sensitivity C-reactive protein;Tumor necrosis factor-alpha;Interleukin-6;Immunoglobulin A;Immunoglobulin G;Immunoglobulin M; | — |
Countries
China
Contacts
Public ContactWei Jianfeng
Shanxi Provincial People's Hospital
Outcome results
None listed