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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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11 June 2018 |
Main ID: |
ACTRN12618000438257 |
Date of registration:
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27/03/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Adductor Canal Block vs. Periarticular Infiltration in Total Knee Arthroplasty
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Scientific title:
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Ultrasound Guided Adductor Canal Block with Levobupivacaine vs Periarticular Infiltration with Levobupivacaine in Primary Total Knee Arthroplasty |
Date of first enrolment:
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1/11/2017 |
Target sample size:
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80 |
Recruitment status: |
Completed |
URL:
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http://www.anzctr.org.au/ACTRN12618000438257.aspx |
Study type:
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Interventional |
Study design:
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Randomised controlled trial
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Phase:
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Key inclusion & exclusion criteria
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Health Condition(s) or Problem(s) studied
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Total Knee Arthroplasty
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Osteoarthritis
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Intervention(s)
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Anesthesia and surgical technique
The patient will admitte to the operating room without any premedication to avoid unwanted sedation, and all patients will subject to spinal anesthesia using a 22 gauge spinal needle and spinal bupivacaine (15 mg) after standard monitoring. During the operation, fluid treatment will perform with 6-9 mL kg h-1 with 0.9% NaCl. All operations will perform by the same surgical team using the same technique and a pneumatic tourniquet. In the operation, midline skin incision, limited medial parapatellar arthrotomy and traditional consecutive medial release will observe. The anterior and posterior ligaments will remove from the knee. Distal femoral and proximal tibia cuts will perform using intramedullary and extramedullary alignment guides, respectively. The balances of the medial / lateral ligaments and flexion / extension spaces will adjuste to confirm the absence of abnormal findings on valgus / varus stress tests, the ability to achieve full knee extensiveness, and whether medial / lateral laxity was absent or untried. Femoral and tibial components in all patients will fix with cement. Patellar implant wil not appy in any patient.
Group ACB-L
After spinal anesthesia, a ultrasoun-guided (10-18 MHz) linear probe in aseptic conditions will place midway between the inguinal ligament and the medial condyle of the knee in a supine position, with the knee slightly twisted and with the leg outstretched (frog leg position). Ultrasonographic image of the saphenous nerve will capture in the adductor channel laterally of the femoral artery beneath the sartorius muscle, shifting to the prop medial-lateral line. Local skin anesthesia will perform with 1% lidocaine. In addition to ultrasound guidance, a peripheral nerve stimulator will use. After the quadriceps motor movement (0.5 mA, 0.1 ms) with the neurostimulator would observed and negative aspiration, 20 ml of 0.25% levobupivacaine will apply to the nerve sheath with 20 gauge, 100 mm, sloped, teflon coated, unipolar needle. Local anesthetic extension will visualize with ultrasonography in the adductor duct.
Group PAI-L
20 mL of 0.9% sodium chloride solution with 20 ml of 0.25% levobupivicaine will prepare in operation table when cement is cured. A total of 40 mL 0.125 mg levobupivacaine will infiltrate into the periosteum of the posterior capsule, femur and tibia, medial and lateral to the joint capsule, quadriceps tendon and vastus medialis oblique, patellar tendon and dermal epidermal junctions.
Postoperative protocol
All patients will treate with 50 mg IV dexketoprofen in the recovery room. Patient-controlled analgesia device (PCA) will insert (IV morphine bolus dose 1 mg, locking time 10 minutes 4 hour limit 500 mg) will record at 24 and 48th hours of morphine consumption. Antibiotic prophylaxis will continue with 3×1 gr Cefosin for 24 hours. The patients will give dexketoprofen every 12 hours and 1 g paracetamol tablet every 8 hours until discharge. 20 mg IV metachloropropamide will give for nausea and vomiting. The patient will usually treat with a knee immobilizer between 12 and 24 hours until quadriceps muscle function will restore. Physical therapy will initiate 24 hours after surgery. He continuous passive motion machine (CPM) in the room in the orthopedic department will start with an initial setting of 45 degrees. CPM will be used in patients on the 2nd day postoperatively and in 2 hour periods. While not using the machine, the patient will apply active flexion-extension movements for the self-knee.
Clinical Evaluation
Sociodemographic and clinical data such as age, sex, weight, height, body mass index, ASA, operation side, operation time, tourniquet time will record. Pain levels during rest and active physical therapy during the preoperative period, postoperative 30 minutes, 2 6, 12, 24, 36 and 48th hours with the visual pain scale (VAS), and the time of first analgesic requirement will record. Postoperative maximal range of knee flexion and extension at 1, 2, 7th days, 2 and 6th weeks will also record. In addition, 3-meter walking data during preoperative period, post-operative 24 and 48th hours will record.
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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