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Objective: This study is designed to evaluate the short-term efficacy of photobiomodulation for improving pain and function in patients that will undergo total knee replacement and decrease in morphine consumption and adverse effects of opioids. Methods: thirty four patients of both genders that will undergo total knee replacement will participate in this randomized controlled double-blind clinical trial. They will be randomly allocated into two groups: Photobiomodulation group 1 with 18 patients and placebo group with 18 patients and group 3 control without device . Photobiomodulation will be performed twice during 48h, using adivice Light-Aid da BrightPhotomedicine- Brasil, com LED de Arsenieto, Gálio and AlumÃnio (AsGaAl) of 850 nm device 3B class, measured and calibrated previously .Five points were irradiated on the knee. The placebo group will be treated with the same laser device, but will not be turned on. All patients will receive treatment sessions of photobiomodulation after 24h and 48 h after peripheral nerve blockade (femoral nerve block and nerve supply), applied in 5 points for 5 minutes (300 seconds) close to the incision (that will be protected by transparent film) and repeated every 24h after totaling 2 applications. Patients will be assessed for duration of surgery and anesthesia, assessment of the pain, time to first rescue analgesia request, physical examination, dosimetry of photobiomodulation and amount of morphine consumption using PCA 24h and 48 hours after nerve blockade after surgery. In addition, adverse effects , sedation, paresthesias, motor blockade, nausea and vomiting will be assessed ever 6h during 48h.
thirty-four patients treated at the Institute of Orthopedics and Traumatology, University of São Paulo School of Medicine Hospital das ClÃnicas (IOT-HC-FMUSP), already identified with knee OA awaiting TKA; the thirty-four selected patients will be divided into two groups with 17 patients in each group:
All patients will undergo photobiomodulation treatment sessions after 24h and 48h of peripheral nerve block (femoral and adductor nerve block), applied in two regions: in the femoral nerve region for 4 minutes (240 seconds) and near the surgical incision (protected with clear film) for 2 minutes (120 seconds) and repeated every 24 hours after, totaling 2 applications in 2 regions (see table 1). Patients will be systematically evaluated with identification, duration of surgery and duration of anesthesia, pain assessment, time of first analgesic rescue request, physical examination, photobiomodulation dosimetry and amount of PCA bolus requested every 6h within within 48 hours after nerve block after knee arthroplasty surgery. In addition to assessing and quantifying adverse effects (motor block, sedation, nausea and vomiting). All pain assessments (VAS) and rescue number requests will be performed by "blinded examiners", ie professionals who will not be aware of the group to which the patient will belong.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Photobiomodulation + patiente controled anaethesia (PCA) group (G1): patients in the immediate postoperateve of knee arthroplasty surgery treated with the Photobiomodulation device connected, 24h and 48h after the peripheral nerve block (femoral nerve and obturator nerve). With conventional analgesia and with the device of PCA. |
|
| Control | Active Comparator | Placebo + PCA group (G2): patients undergoing knee arthroplasty surgery treated with the Photobiomodulation device switched off, in 24h and 48h after peripheral nerve blockade (femoral nerve and obturator nerve). With conventional analgesia and with the PCA apparatus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photobiomodulation + patiente controled anaethesia (PCA) | Device | Patients in the immediate postoperateve of knee arthroplasty surgery treated with the Photobiomodulation device connected, 24h and 48h after the peripheral nerve block (femoral nerve and obturator nerve). With conventional analgesia and with the device of PCA. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate if photobiomodulation improves postoperative pain by VAS during hospital stay. | Apply the VAS (Visual Analog Scale), range: 0 no pain - 100 worse pain | Day 2 after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate adverse events arising within 48 hours after surgery | Will evaluate at 6:00 (immediate postoperative day) 6:00 , 12:00., 18:00 (1st postoperative day) and 6:00 and 12:00 (second postoperative day) | Day 2 after procedure |
| Evaluate morphine consumption in a patient-controlled analgesia device (PCA) from the immediate postoperative period up to 48h after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Livia Ab | Contact | 1126612473 | murmedicina@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| George Freire, MD | University of São Paulo General Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23459843 | Background | Hawker GA, Badley EM, Borkhoff CM, Croxford R, Davis AM, Dunn S, Gignac MA, Jaglal SB, Kreder HJ, Sale JE. Which patients are most likely to benefit from total joint arthroplasty? Arthritis Rheum. 2013 May;65(5):1243-52. doi: 10.1002/art.37901. | |
| 27400891 | Background | Fedriani de Matos JJ, Atienza Carrasco FJ, Diaz Crespo J, Moreno Martin A, Tatsidis Tatsidis P, Torres Morera LM. Effectiveness and safety of continuous ultrasound-guided femoral nerve block versus epidural analgesia after total knee arthroplasty. Rev Esp Anestesiol Reanim. 2017 Feb;64(2):79-85. doi: 10.1016/j.redar.2016.05.008. Epub 2016 Jul 9. English, Spanish. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D008659 | Metabolic Diseases |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Not provided
| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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|
| Placebo + patiente controled anaethesia (PCA) | Device | Patients in the immediate postoperateve of knee arthroplasty surgery treated with the Photobiomodulation device switched off, in 24h and 48h after peripheral nerve bloc (femoral nerve and obturator nerve). With conventional analgesia and with the device of PCA. |
|
Through the patient-controlled analgesia (PCA) method |
| Day 2 after procedure |
| Measure time to first request for analgesia rescue after peripheral nerve block | Through the patient-controlled analgesia (PCA) method | Day 2 after procedure |
| 24237004 | Background | Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15. |
| 29392204 | Background | Pogatzki-Zahn EM, Segelcke D, Schug SA. Postoperative pain-from mechanisms to treatment. Pain Rep. 2017 Mar 15;2(2):e588. doi: 10.1097/PR9.0000000000000588. eCollection 2017 Mar. |
| 22923827 | Background | Shanthanna H, Huilgol M, Manivackam VK, Maniar A. Comparative study of ultrasound-guided continuous femoral nerve blockade with continuous epidural analgesia for pain relief following total knee replacement. Indian J Anaesth. 2012 May;56(3):270-5. doi: 10.4103/0019-5049.98776. |
| 25149364 | Background | Al-Zahrani T, Doais KS, Aljassir F, Alshaygy I, Albishi W, Terkawi AS. Randomized clinical trial of continuous femoral nerve block combined with sciatic nerve block versus epidural analgesia for unilateral total knee arthroplasty. J Arthroplasty. 2015 Jan;30(1):149-54. doi: 10.1016/j.arth.2014.07.032. Epub 2014 Jul 31. |
| 10365442 | Background | Karu T. Primary and secondary mechanisms of action of visible to near-IR radiation on cells. J Photochem Photobiol B. 1999 Mar;49(1):1-17. doi: 10.1016/S1011-1344(98)00219-X. |
| 21160232 | Background | Pinto FC, Chavantes MC, Pinto NC, Alho EJ, Yoshimura EM, Matushita H, Krebs VL, Teixeira MJ. Novel treatment immediately after myelomeningocele repair applying low-level laser therapy in newborns: a pilot study. Pediatr Neurosurg. 2010;46(4):249-54. doi: 10.1159/000319363. Epub 2010 Dec 15. |
| 15561731 | Background | Bjordal JM, Ljunggren AE, Klovning A, Slordal L. Non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomised placebo controlled trials. BMJ. 2004 Dec 4;329(7478):1317. doi: 10.1136/bmj.38273.626655.63. Epub 2004 Nov 23. |
| 10204446 | Background | Tam G. Low power laser therapy and analgesic action. J Clin Laser Med Surg. 1999 Feb;17(1):29-33. doi: 10.1089/clm.1999.17.29. |
| 24634001 | Background | Masoumipoor M, Jameie SB, Janzadeh A, Nasirinezhad F, Soleimani M, Kerdary M. Effects of 660- and 980-nm low-level laser therapy on neuropathic pain relief following chronic constriction injury in rat sciatic nerve. Lasers Med Sci. 2014 Sep;29(5):1593-8. doi: 10.1007/s10103-014-1552-1. Epub 2014 Mar 16. |
| 22009383 | Background | Medalha CC, Di Gangi GC, Barbosa CB, Fernandes M, Aguiar O, Faloppa F, Leite VM, Renno AC. Low-level laser therapy improves repair following complete resection of the sciatic nerve in rats. Lasers Med Sci. 2012 May;27(3):629-35. doi: 10.1007/s10103-011-1008-9. Epub 2011 Oct 19. |
| 27027049 | Background | Fukuda VO, Fukuda TY, Guimaraes M, Shiwa S, de Lima Bdel C, Martins RA, Casarotto RA, Alfredo PP, Bjordal JM, Fucs PM. SHORT-TERM EFFICACY OF LOW-LEVEL LASER THERAPY IN PATIENTS WITH KNEE OSTEOARTHRITIS: A RANDOMIZED PLACEBO-CONTROLLED, DOUBLE-BLIND CLINICAL TRIAL. Rev Bras Ortop. 2015 Dec 6;46(5):526-33. doi: 10.1016/S2255-4971(15)30407-9. eCollection 2011 Sep-Oct. |
| 34800495 | Derived | de Rezende MU, Varone BB, Martuscelli DF, Ocampos GP, Freire GMG, Pinto NC, de Sousa MVP. Pilot study of the effect of therapeutic photobiomodulation on postoperative pain in knee arthroplasty. Braz J Anesthesiol. 2022 Jan-Feb;72(1):159-161. doi: 10.1016/j.bjane.2021.07.040. Epub 2021 Nov 17. |
| D009750 |
| Nutritional and Metabolic Diseases |