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This randomized, double blind controlled trial is designed to investigate the potential benefits of radiofrequency in terms of analgesia and functional outcome, compared to the conventional continuous adductor canal block, for patients undergoing total knee arthroplasty for osteoarthritis.
The aim of this study is to compare the efficacy of two analgesia techniques in patients undergoing Total Knee Arthroplasty (TKA) on the functional recovery and pain control: Pulsed and Continuous Radiofrequency (PRF and TRF) applied respectively to the saphenous nerve and to the genicular nerves of the knee (femoral and sciatic branches) compared with Continuous adductor canal block with local anesthetics (CACB).
The Null Hypothesis is that no difference exists in the functional recovery, in pain medication consumption and in postoperative exercise and physical performance between two groups of patients submitted to TKA with the two different modalities of analgesia.
To test the null hypothesis we hypothesize as clinically relevant:
To test the null Hypothesis, 40 patients are needed (20 for each group).
The primary outcome measures will be:
Secondary outcome measures include: Pain evaluation with the use of VAS at rest, VAS on walking and on knee flexion; functional outcome evaluation with the 6 min walk tests, degree of knee flexion, Scores obtained in self-assessment questionaire (WOMAC-Western Ontario and McMaster University questionaire for knee osteoarthritis and CHAMPS-Community Healthy Activities Model Program for Seniors). These values will be compared with baseline values recorded before surgery.
It is hypothesized that PRF and TRF of the saphenous nerve and genicular nerves to the knee joint can improve the early and late functional recovery and the pain control after TKA when compared with the CACB
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed and Continuous Radiofrequency | Experimental | In this group of patients undergoing total knee arthroplasty (allocation of patients is randomized), Pulsed radiofrequency (PRF) is applied to the saphenous nerve of the knee, associated to Continuous Radiofrequency (TRF) applied to the genicular nerves of the knee . A sham catheter is inserted in the mid-tigh to simulate a continuous adductor canal block, and connected to an infusion of normal saline (assessor and patient blinded to the treatment) |
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| Continuous adductor canal block | Active Comparator | Continuous Adductor Canal Block Continuous adductor canal block is performed in this group of patients, with a catheter infusing ropivacaine 0.2% in the first 48 hours after surgery. The solutions bags are labelled in order to make assessor and patients, blinded to the treatment (Ropivacaine vs Normal Saline) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed and Continuous Radiofrequency | Procedure | Preoperative pulsed radiofrequency of the saphenous nerve and Continuous radiofrequency of the genicular nerves of the knee joint. The saphenous nerve will be approached at the adductor canal and it will be treated with Pulsed RF for 4 minutes at 42 Celsius degrees. Ropivacaine 0.5% 10ml with Dexamethasone 10mg will be injected after the RF. The Genicular terminal branches of the sciatic and femoral nerves will be treated with Continuous RF for 3 min at 80 Celsius degrees and then with 2 ml of Ropivacaine 0.5% and 10 mg of Methylprednisolone to each nerve (5 in total) A sham catheter in the mid-thigh will be placed for patients in the RF group, infusing Normal Saline 0.9% and simulating a Continuous Adductor Canal Block. To blind the investigator to the type of treatment for the postoperative assessment , every solution bag will be prepared by the Pharmacy of the Hospital, covered with a plastic envelope and labeled as "Study Solution". |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morphine consumption | first postoperative day (first 24 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Timed-Up and Go Test | TUG measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to use any mobility aids that they would normally require | 2nd postoperative day |
| Six minutes walk test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Carli, Professor | Mc Gill Univeristy Health Center | Study Director |
| Juan Francisco Asenjo, Professor | Mc Gill Univeristy Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre, Montreal General Hospital | Montreal | Quebec | H3G1A4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25468584 | Result | Patterson ME, Bland KS, Thomas LC, Elliott CE, Soberon JR Jr, Nossaman BD, Osteen K. The adductor canal block provides effective analgesia similar to a femoral nerve block in patients undergoing total knee arthroplasty--a retrospective study. J Clin Anesth. 2015 Feb;27(1):39-44. doi: 10.1016/j.jclinane.2014.08.005. Epub 2014 Nov 22. | |
| 26079800 |
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| Continuous Adductor Canal Block | Drug | The patients in the Adductor canal group, will have a catheter for peripheral nerve block inserted under strict asepsis in the adductor canal under ultrasound guidance, and will receive for postoperative analgesia a 48-h continuous infusion of Ropivacaine 0.2% at 8 ml/hour The patients will receive, intraoperatively 10 mg of Dexamethasone i.v. To blind the investigator who will do the postoperative assessment to the type of treatment, every solution bag will be prepared by the Pharmacy of the Hospital, covered with a plastic envelope and labeled as "Study Solution". It will be always possible to crack the code and find out to which group the patient belongs |
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This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes |
| 6 weeks after surgery |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items);Stiffness (2 items); Physical Function (17 items). The Extent of pain, stiffness in the knee, and physical function related to the disability due to the knee osteoarthritis are assessed with the WOMAC index, before and 6 weeks after surgery (Western-Ontario-McMaster-Universities-Osteoarthritis-Index). | 6 weeks after surgery |
| Visual Analogue Scale (VAS) for pain at rest | 6 weeks after surgery |
| Visual Analogue Scale (VAS) for pain at movement | 6 weeks after surgery |
| Pain medication consumption | 6 weeks after surgery |
| Visual Analogue Scale (VAS) for pain at rest | first 24 hours after surgery |
| Visual Analogue Scale (VAS) for pain at movement | First 24 hours after surgery |
| CHAMPS (Community Healthy Activities Model Program for Seniors) questionnaire | 6 weeks after surgery |
| Machi AT, Sztain JF, Kormylo NJ, Madison SJ, Abramson WB, Monahan AM, Khatibi B, Ball ST, Gonzales FB, Sessler DI, Mascha EJ, You J, Nakanote KA, Ilfeld BM. Discharge Readiness after Tricompartment Knee Arthroplasty: Adductor Canal versus Femoral Continuous Nerve Blocks-A Dual-center, Randomized Trial. Anesthesiology. 2015 Aug;123(2):444-56. doi: 10.1097/ALN.0000000000000741. |
| 20551021 | Result | Carli F, Clemente A, Asenjo JF, Kim DJ, Mistraletti G, Gomarasca M, Morabito A, Tanzer M. Analgesia and functional outcome after total knee arthroplasty: periarticular infiltration vs continuous femoral nerve block. Br J Anaesth. 2010 Aug;105(2):185-95. doi: 10.1093/bja/aeq112. Epub 2010 Jun 14. |
| 25041873 | Result | Shah NA, Jain NP. Is continuous adductor canal block better than continuous femoral nerve block after total knee arthroplasty? Effect on ambulation ability, early functional recovery and pain control: a randomized controlled trial. J Arthroplasty. 2014 Nov;29(11):2224-9. doi: 10.1016/j.arth.2014.06.010. Epub 2014 Jun 19. |
| 24121608 | Result | Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015. |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D006339 | Heart Rate |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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