Tibiofibular Fracture
Conditions
Interventions
Trial Group:Ultrasound-guided femoral nerve block combined with sciatic nerve block, with 0.2% ropivacaine (dose calculated at 0.5 mg*kg^-1, single nerve block dose not exceeding 1 mg*kg^-1, total dos
after injection, block effect confirmed after 10-15 min observation
other anesthesia induction and maintenance protocols same as control group.
Control Group:Ultrasound-guided sciatic nerve block (without femoral nerve block), with 0.2% ropivacaine (dose calculated at 0.5 mg*kg^-1, single nerve block dose not exceeding 1 mg*kg^-1, total dose
other anesthesia induction and maintenance protocols same as trial group.
Sponsors
Children's Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Aged 6 to 12 years, diagnosed with tibial and fibular fracture (closed or open), scheduled for surgical treatment under general anesthesia (open reduction and internal fixation or closed reduction and internal fixation); 2. American Society of Anesthesiologists (ASA) physical status classification Grade I–II; 3. Tourniquet required intraoperatively, with an expected tourniquet inflation time of 60–120 minutes; 4. Normal preoperative liver and kidney function, coagulation function, and electrocardiogram, with no history of local anesthetic allergy.
Exclusion criteria
Exclusion criteria: 1. Patients with comorbid cardiopulmonary diseases (such as congenital heart disease, arrhythmia, heart failure), hepatic or renal insufficiency, or hematological disorders 2. Presence of severe coagulation abnormalities 3. Allergy to local anesthetics, general anesthetics, or other drugs used in the study 4. Morbidly obese patients with a body mass index (BMI) >=35kg*m^-2 5. Patients with comorbid metabolic diseases (such as diabetes, thyroid dysfunction), long-term hormone use, neuromuscular diseases (such as cerebral palsy, peripheral neuropathy), infectious diseases (such as hepatitis B, hepatitis C, AIDS), or long-term use of analgesics or psychotropic drugs 6. Expected tourniquet inflation time 120min, or inability to use a tourniquet during surgery 7. Fracture site with severe soft tissue injury, infection, or need for emergency surgery (unable to complete the full screening process preoperatively) 8. Patient guardians refusing to sign the informed consent form, or inability to cooperate with postoperative follow-up 9. History of lower limb nerve block, history of nerve injury, or presence of other diseases affecting lower limb sensory or motor function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of tourniquet-induced hypertension (TH) defined as systolic blood pressure (SBP) exceeding baseline by >30% at any intraoperative time point; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemodynamic parameters (SBP, MAP, HR);Total intraoperative opioid consumption;Total postoperative analgesic drug consumption;Postoperative pain score (NRS);Incidence of sleep disturbance;Regional anesthesia-related parameters (incidence of femoral nerve sensory/motor blockade, sensory block recovery time, motor block recovery time);Incidence of adverse events (local anesthetic allergy, nausea and vomiting, dizziness, bradycardia, hypotension, lower limb numbness/pain, etc.);Pain treatment satisfaction;Other parameters (surgical duration, tourniquet inflation time, PACU stay duration, postoperative hospitalization days); | — |
Countries
China
Contacts
Public ContactWang Qian
Children's Hospital of Soochow University
Outcome results
None listed