Knee replacement
Conditions
Interventions
Experimental group :Ultrasound-guided liposomal retractor block with bupivacaine
Control group:Ultrasound-guided retractor tube block with bupivacaine injection
Sponsors
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Planned to undergo unilateral total knee arthroplasty under general anesthesia; 2. Age >= 65 years old, regardless of gender; 3. 18 kg/m^2 <= BMI <= 28 kg/m^2; 4. The American Society of Anesthesiology (ASA) classifies patients as Grade I-II.
Exclusion criteria
Exclusion criteria: 1. Subjects with ipsilateral adductor tube, saphenous nerve malformation, or other neuropathy, such as diabetes peripheral neuropathy, multiple sclerosis, nerve root disease, or patients with traumatic surgery history and incomplete recovery after treatment; 2. Subjects with a history of newly diagnosed myocardial infarction or unstable angina within the first 6 months of randomization; 3. Subjects with a history of combined ischemic stroke or transient ischemic attack (TIA); 4. Subjects with concomitant psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive impairment; 5. Merge other physical pain that may affect postoperative pain assessment (such as significant pain in other joints, including non affected knee joints, chronic neuropathic pain, concurrent or prior contralateral knee replacement, concurrent foot surgery); 6. History of severe or refractory postoperative nausea or vomiting; persistent or recurrent nausea and/or vomiting from other causes, including but not limited to gastric pyloric obstruction, hypercalcemia, or active peptic ulcer; 7. Comorbid deep vein thrombosis-related disease; 8. Abnormal laboratory findings during the screening period: (1) fasting glucose (FPG) >= 10.0 mmol/L; (2) abnormal liver function: aspartate aminotransferase (AST) or/and alanine aminotransferase (ALT) and/or total bilirubin (TBiL) >= 1.5 × ULN; (3) abnormal renal function: creatinine (Cr) >= 1.5 × ULN, or in dialysis subjects; (4) abnormal coagulation function: PT > 1.5 × ULN, or in dialysis subjects; and (5) abnormal blood pressure: PT > 1.5 × ULN. Abnormal coagulation function: PT > upper limit of normal value +3s and/or APTT > upper limit of normal value +10s; (5) Platelet (PLT) 9. Combined drugs: (1) known allergy or contraindication to ropivacaine or other amide local anesthetics and other drugs that may be used during the trial, such as propofol, lidocaine, opioids, etc.; (2) the use of antiarrhythmic drugs or drugs affecting liver metabolism within five drug half-life before randomization; (3) intravenous or intra-articular injection of corticosteroids; (4) sedative drugs: benzodiazepines benzodiazepine (such as diazepam, flurazepam, diazepam, diazepam, diazepam). diazepam, flurazepam, oxazepam, clozapine, triazolam, alprazolam, eszopiclone, midazolam, etc.), diazepam,Barbiturates, Carbamazepine, Phenytoin, Magnesium Sulfate (permitted for topical use only, and for intravenous low-dose electrolyte replacement), and Chloral Hydrate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the pain intensity time curve AUC0-72h in resting state within 72 hours after starting injection of the experimental drug; | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the resting state pain intensity-time curve AUC;Area Under the Pain Intensity-Time Curve in Motion AUC;Postoperative pain intensity scores in resting (NRS-R) and exercise (NRS-A) states;Proportion of subjects not using remedial analgesia;Cumulative use of remedial analgesic drugs;Quadriceps muscle strength score; | — |
Countries
China
Contacts
Public ContactWang Hongqian
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Outcome results
None listed