Total Knee Arthroplasty Clinical Trial
Official title:
The Effect of Continuous Femoral Nerve Block With Modulation of Depth of Anesthesia on Prognosis of Patients Receiving Total Knee Arthroplasty
The interaction of analgesia and sedation ot their effect on the prognosis of surgical patients still need to be elucidated.Currently, how to optimize intra-operative Analgesia and sedation to improve the prognosis of surgical patients is still a mystery.Intra-operative nerve block provided regional analgesia of the operated knee, which reduced the dosages of sedatives and analgesics.Based on a pilot study,the investigators found a decrease of post-operative adverse composite outcomes with the use of continuous femoral nerve block (2% versus 7%) ,therefore, the investigators postulate that general analgesia with lighter sedation in combination with peripheral nerve block could reduce the post-operative morbidity compared with deeper sedation.This randomized controlled trial is designed to test this hypothesis in patients receiving unilateral knee arthroplasty.
Status | Not yet recruiting |
Enrollment | 380 |
Est. completion date | |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Men and women over the 18 years and younger than 80 years old - Scheduled to receive selective unilateral knee replacement. Exclusion Criteria: - Bilateral knee replacement - The secondary knee revision and knee surgery not interfering with articular joint cavity (wound debridement and suture) - American Society of Anesthesiology (ASA) classification of anesthesia risk IV and V grade - Body mass index higher than 35 - Coagulation dysfunction, which is assessed by activated partial thromboplastin time (APTT) higher than the upper limit by 10s; prothrombin time (PT) higher than the upper limit by 5s; International Normalized Ratio (INR) higher than 1.3, or any of criteria met above; - Pre-operative hypoxia (SpO2< 90% or PO2<60 mmHg) - Pre-operative hypercapnia (PCO2> 50 mmHg) - Local infection of puncture sites - Neurological diseases and pre-operative psychological disorders - Uncontrolled general infection - Intra-operative cardiac arrest. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The Department of Anesthesiology,the first Affiliated Hospital of Chongqing Medical University | Chonqqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Min Su |
China,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major post-operative complications | Major post-operative complications summed the incidence of major complications post-operatively( (post-operative pulmonary infection,need of mechanical respiratory support,myocardio-infarction,deep venous thrombosis, pulmonary embolism, stroke, poor wound healing,all-cause post-operative death within 30 days),participants with at least one episode of the complications will be calculated as participants with complications,both the number of participants and number of events will be calculated. | From the end of surgery to 30 days post-operatively | No |
Secondary | Acute post-operative Pain assessed by visual analogue scale | Acute | At 12 hours ,24hours ,48hours,72 hours post-operatively | No |
Secondary | Dosages of rescue medications (mg) | the dosages of tramadol,pethidine and Parecoxib during the use of patient controlled analgesia (PCA) post-operatively | From the end of surgery to 3 days post-operatively | No |
Secondary | Dosages of intra-operative vasopressors,anesthetics and analgesics | during the surgery | No | |
Secondary | Life quality measured by euro-quality-5 dimensions (EQ-5D) | EQ-5D is a commonly used scale for calibration of life quality | 3 months post-operatively | No |
Secondary | Adverse events associated with the femoral catheter | local infection,hematoma,drop-out of the catheter,nerve injury | From the insertion of the catheter to 3 days post-operatively | Yes |
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