Tibial plateau fracture
Conditions
Interventions
Bupivacaine group :On the basis of conventional treatment (ice application, leg elevation), take Yunnan Baiyao Capsules orally (0.25g, 2 capsules each time, 4 times a day). Take Yunnan Baiyao Capsules
Control group:On the basis of conventional treatment, take Yunnan Baiyao Capsule placebo orally (0.25g, 2 capsules each time, 4 times a day)
Sponsors
Beijing Jishuitan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. The participants was diagnosed with tibial plateau fracture by X-ray examination and was diagnosed with qi stagnation and blood stasis syndrome in traditional Chinese medicine; 2. All treatments adopted open reduction and internal fixation for tibial plateau fractures; 3. The fracture is a non-pathological fracture; 4. Go to the hospital within 48 hours after injury; 5. Participants aged between 20 and 60, regardless of gender, with surgical indications, and who agree to undergo surgery; 6. Vital signs are stable; 7. The subjects understood and voluntarily participated in this trial and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Open fractures with combined vascular and nerve injuries, patients with abnormal pre-injury coagulation function caused by various chronic diseases in the past, and patients with deep vein thrombosis of the lower extremities with a history of knee surgery in the past; 2. Participants who have a history of osteoarthritis or rheumatoid arthritis in the ipsilateral, contralateral or bilateral knee joints and have a previous history of diseases such as poliomyelitis, resulting in asymmetry of both lower extremities before injury; 3. Participants with a history of knee surgery, old tibial plateau fractures, or those diagnosed by traditional Chinese medicine as not having qi stagnation and blood stasis syndrome; 4. Participants with hemorrhagic diseases such as abnormal vascular walls, thrombocytopenia or abnormal platelet function, abnormal coagulation, anticoagulation or fibrinolysis, and abnormal combined hemostasis mechanisms; 5. Have a history of allergy to Yunnan Baiyao; 6. Participants with severe primary diseases of the heart, brain, lungs, liver, kidneys and other organs, chronic metabolic diseases, mental illness, and those with other contraindications for surgery; 7. According to the researcher's judgment, after enrollment, it may affect the follow-up and compliance of the subjects and other situations that are prone to cause loss to follow-up; 8. Pregnant or preparing to become pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of swelling 14 days after surgery;Swelling improve percent 14 days after surgery;Incidence of surgery complication; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS score ;Incidence of adverse reactions;Degree of swelling before, 1,3,7 days after surgery;Swelling improve percent 3,7 days after surgery;Knee HSS score;TCM syndrome score;Hospital stay; | — |
Countries
China
Contacts
Public ContactTing Li
Beijing Jishuitan Hospital, Capital Medical University
Outcome results
None listed