breast cancer
Conditions
Interventions
Blank control group:A single injection of 20 ml of 0.9% normal saline through an incision drainage tube
Positive control group:A single injection of 20 ml of 0.5% ropivacaine through an incision drainage tube
Experimental group:A single injection of bupivacaine liposome (133mg, added with normal saline to a total volume of 20ml) was administered through a drainage tube.
Sponsors
Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-64 years old, female; 2.Elective unilateral radical mastectomy for breast cancer (including modified radical mastectomy); 3.ASA classification I-III; 4.Weight >= 50 kg; 5.Body mass index (BMI) < 30 kg/m^2; 6.Before the operation, the patient was able to understand the usage of the Visual Analogue Scale (VAS), had no language, hearing or cognitive impairments, and could cooperate with the postoperative pain assessment; 7.Postoperative incision drainage tubes can be successfully placed (for drug administration and drainage). 8.Agree to use patient-controlled intravenous analgesia pumps (PCIA) as a unified remedial analgesia measure; 9.Voluntarily sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Those who are allergic to amide local anesthetics or liposome components; 2.Long-term preoperative use of opioid drugs (>=3 months) or a history of drug abuse; 3.Combined with severe arrhythmia, uncontrolled hypertension, and severe liver and kidney dysfunction; 4.There were already chronic pain syndromes or neuropsychiatric disorders affecting the pain assessment before the operation; 5.For cases where the surgical scope needs to be expanded to extensive chest wall resection or flap reconstruction; 6.Pregnant or lactating women; 7.At the same time, participate in other interventional clinical studies; 8.There is a risk of skin infection, damage, cellulitis or implant infection in the chest wall on the surgical side or the area where the drainage tube is intended to be indwelled before the operation; 9.Contraindications for the placement of drainage tubes (such as extensive radiation dermatitis of the chest wall, severe coagulation dysfunction, anatomical abnormalities at the intended puncture site, etc.); 10.Coagulation dysfunction (platelet count 1.5, or PTT prolonged > 1.5 times the upper limit of normal), or currently receiving uninterrupted anticoagulant/antiplatelet therapy (such as warfarin, rivaroxaban, clopidogrel, etc., except for aspirin =100mg/ day); 11.Combined with severe systemic infection, sepsis or preoperative body temperature > 38.5?; 12.The researchers judged that there were any conditions that might increase the risk of toxic reactions to local anesthetics (such as severe hypoproteinemia, uncorrected acidosis, and severe electrolyte imbalance). 13.Any reason that prevents the placement or retention of the drainage tube (such as severe adhesions caused by previous ipsilateral chest wall surgery, thoracic deformity, etc.); 14.There is a personal or family history of malignant high fever; 15.Other circumstances that the researcher deems unsuitable for participation in this study (such as poor compliance, inability to complete follow-up, etc.);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative consumption of morphine (mg) within 0 to 72 hours after the operation;The time of the first postoperative remedial analgesia (hours); | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS score at rest;Adverse events (nausea, vomiting, pruritus, local anesthetic toxicity reactions, etc.;The healing condition of the wound;length of stay;VAS score during the activity;Complications related to the drainage tube;The first time to get out of bed for activities; | — |
Countries
China
Contacts
Public ContactLiu Yulin
Affiliated Hospital of Southwest Medical University
Outcome results
None listed