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Clinical Trials/RBR-9zr2fr
RBR-9zr2fr
Recruiting
未知

Immersion anesthesia in total knee arthroplasty: a new proposal to reduce pain and opioid consumption. Randomized clinical trial

Fundacao Hospital Adriano Jorge0 sitesSeptember 19, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
knee osteoarthritis
Sponsor
Fundacao Hospital Adriano Jorge
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 19, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Intervention

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients regularly enrolled in the institution where the study will be performed with classic indication scheduled for knee replacement, recommended by Camanho, will be included: medial or lateral clamping with obliteration of the articular space, deviations in the femoro\-tibial varus greater than 15 degrees. Deviations in femoro\-tibial valgus greater than 10 degrees; frontal plane femorotibial subluxation greater than 10mm. Tibial anteriorization in relation to the femur on lateral radiographs. Severe impairment of two of the three knee joint compartments (medial femorotibial, lateral femorotibial or patellofemoral), and conservative treatment failed for at least three months when these criteria were not met. Patients with primary degenerative knee osteoarthritis. For this radiographic evaluation, patients with knee arthrosis stage III and IV were considered according to the Kellgren\-Lawrence classification. Patients aged 50 to 80 years. Patients who are willing and able to sign written informed consent for study involvemen. Following a reasonably detailed study description, patients willing to participate in treatment, as well as pre\-, intra\- and postoperative evaluation criteria. Patients operated by the principal investigator and his team

Exclusion Criteria

  • Patients with previous knee surgeries will be excluded from the study. History of knee fractures. Neurological, muscular, rheumatological, neoplastic or infectious diseases that could cause some form of joint involvement (gout, multiple myeloma, psoriasis, lymphoma, Paget's disease, rheumatoid arthritis, chronic renal failure, osteomyelitis, ankylosing spondylitis, systemic lupus erythematosus.; Patients undergoing revision or bilateral knee replacement. Patients with more than 30 degrees of malalignament of the knee (varus or valgus) tibial femoral. Patients with any contraindications to the use of acetaminophen, aspirin, tranexamic acid, tenoxicam, dexamethasone or any other study\-related medication; Patients on chronic opioid use (defined as daily use for more than 3 months). Patients with advanced kidney disease (defined as Glomerular Filtration Rate minus than 30\) or severe liver disease. Patients who are chronic alcohol users (defined as more than 1 dose per night for women or more than 2 doses per night for men. Patients with a score of 3 from the American Society of Anesthesiologistis. Patients with poorly controlled diabetes mellitus (glycated hemoglobin bigger than 7\.5 in pre\-admission tests). Patients on steroid or immunosuppressive drugs within 3 months of surgery. Preoperative history of venous thromboembolism or deep vein thrombosis. Patients with a hypercoagulability disorder. Patients with a concomitant physical condition that may require analgesic treatment during study follow\-up. Patients with body mass index bigger than 40 kg / m2\. Patients with bacteremia, systemic infection or surgical site infection. Patients currently involved in another drug or device study. Patients undergoing general anesthesia. Patients not operated at the study hospital. Refusal or impossibility of the patient to perform postoperative rehabilitation. Non\-acceptance by anesthesiologist to follow project protocol. Allergic patients to the medications used in the protocol. Patients who claim to be indigenous

Outcomes

Primary Outcomes

Not specified

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