Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000438257
Ethics application status
Approved
Date submitted
15/09/2017
Date registered
27/03/2018
Date last updated
27/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adductor Canal Block vs. Periarticular Infiltration in Total Knee Arthroplasty
Scientific title
Ultrasound Guided Adductor Canal Block with Levobupivacaine vs Periarticular Infiltration with Levobupivacaine in Primary Total Knee Arthroplasty
Secondary ID [1] 292891 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 304737 0
Osteoarthritis 305204 0
Condition category
Condition code
Anaesthesiology 304060 304060 0 0
Pain management
Musculoskeletal 304518 304518 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 299128 0
Treatment: Drugs
Intervention code [2] 299461 0
Prevention
Intervention code [3] 299462 0
Treatment: Surgery
Comparator / control treatment
Compaire of Group ACB-L to Group PAI-L
Control group
Active

Outcomes
Primary outcome [1] 303389 0
postoperative pain scores. (100mm visual analogue scale=VAS)
Timepoint [1] 303389 0
Pain levels during rest and active physical therapy during the preoperative period (baseline, 1 day prior to surgery) postoperative 30 minutes, 2, 6, 12, 24, 36 and 48th( (endpoint) hours will record.
Primary outcome [2] 303760 0
range of knee motion (the degree of flexion and extension motion were measured with the goniometer)
Timepoint [2] 303760 0
Postoperative maximal range of knee flexion and extension at baseline (1st day), 2, 7th days, 2 and 6th weeks (endpoint) will also record.
Secondary outcome [1] 338814 0
The time of first analgesic requirement (as minute)
Timepoint [1] 338814 0
The time of first analgesic requirement data post-operative 24 and 48th hours will record.
Secondary outcome [2] 340091 0
Total morphine consumption (as miligram)
Timepoint [2] 340091 0
Total morphine consumption data post-operative 24 and 48th hours will record.
Secondary outcome [3] 340092 0
the time to walk 3-meter
Timepoint [3] 340092 0
3-meter walking data post-operative 24 and 48th hours will record.

Eligibility
Key inclusion criteria
After obtaining participants’written informed consent, 80 patients, 40-85 years who were American Society of Anesthesiologists (ASA) I-III undergoing single TKA for degenerative joint disease will enroll in the clinic study.
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA IV-V, over 40 years old or over 85 years old, chronic pain syndrome or neuropathic pain, over 5 mg / day oral morphine or equivalent opioids, morbid obese, coagulation-deficient, upper gastrointestinal hemorrhage or perforation story with , patients who can not walk without help due to an out - of - knee disease, patients who were allergic to medications used in the study will exclude from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2017
Date of last participant enrolment
Anticipated
Actual
1/01/2018
Date of last data collection
Anticipated
Actual
15/02/2018
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 9214 0
Turkey
State/province [1] 9214 0

Funding & Sponsors
Funding source category [1] 297521 0
University
Name [1] 297521 0
Selcuk Üniversity
Country [1] 297521 0
Turkey
Primary sponsor type
University
Name
Selcuk University
Address
Selcuk University, Medical Faculty , Alaadin Keykubat Yerleskesi Tip Fakultesi Selcuklu - Konya/TURKEY
Country
Turkey
Secondary sponsor category [1] 296527 0
None
Name [1] 296527 0
Address [1] 296527 0
Country [1] 296527 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298619 0
Necmettin Erbakan University, medical Faculty Ethic Committee
Ethics committee address [1] 298619 0
Ethics committee country [1] 298619 0
Turkey
Date submitted for ethics approval [1] 298619 0
27/09/2017
Approval date [1] 298619 0
27/09/2017
Ethics approval number [1] 298619 0
(Ref no: 2017/146).

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77670 0
A/Prof Faruk Cicekci
Address 77670 0
Selcuk Univercity, Medical Faculty, Department of Anesthesiology and Reanimation
Alaaddin Keykubat Yerleskesi, Selcuklu/Konya postcode:42250
Country 77670 0
Turkey
Phone 77670 0
+905057649235
Fax 77670 0
Email 77670 0
[email protected]
Contact person for public queries
Name 77671 0
Inci Kara
Address 77671 0
Selcuk Univercity, Medical Faculty, Department of Anesthesiology and Reanimation
Alaaddin Keykubat Yerleskesi, Selcuklu/Konya postcode:42250
Country 77671 0
Turkey
Phone 77671 0
+905054831819
Fax 77671 0
Email 77671 0
[email protected]
Contact person for scientific queries
Name 77672 0
Jale Bengi Celik
Address 77672 0
Selcuk Univercity, Medical Faculty, Department of Anesthesiology and Reanimation
Alaaddin Keykubat Yerleskesi, Selcuklu/Konya postcode:42250
Country 77672 0
Turkey
Phone 77672 0
+905335656338
Fax 77672 0
Email 77672 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseUltrasound-guided adductor canal block using levobupivacaine versus periarticular levobupivacaine infiltration after total knee arthroplasty: A randomized clinical trial.2019https://dx.doi.org/10.1590/1516-3180.2018.0269101218
N.B. These documents automatically identified may not have been verified by the study sponsor.