Photobiomodulation on Postoperative Pain

NCT04190797 | Unknown

• 1 other identifier: 23338619.4.0000.0068
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 Alumínio (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.

Conditions

Knee Osteoarthritis; Metabolic Disease

Keywords

Laser Therapy; Osteoarthritis; Knee

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Evaluate adverse events arising within 48 hours after surgery

  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

  Day 2 after procedure

• Measure time to first request for analgesia rescue after peripheral nerve block

  Day 2 after procedure

Study Arms (2)

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.

Device: Photobiomodulation + patiente controled anaethesia (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.

Device: Placebo + patiente controled anaethesia (PCA)

Interventions

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.

Experimental

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.

Control

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women diagnosed with OAJ with comorbidities (metabolic syndrome, ie, OAJ + at least two overweight / central obesity, diabetes, dyslipidemia, high blood pressure)
• Age between 60 and 75 years awaiting primary TKA at IOT-HC-FMUSP
• Patients not submitted to previous lower limb arthroplasty.
• Patients not submitted to knee infiltration up to 6 months before study.
• Patients without personal history of cognitive, psychiatric and / or neurological disorders, whose symptoms presented at the moment of the evaluation are related or significantly interfere with the functions of attention, memory, logical reasoning, understanding, in order to impair the assimilation of the given guidelines.
• Patients with no personal history of inflammatory arthritis (rheumatoid arthritis, for example)

You may not qualify if:

• Contraindication for spinal anesthesia and / or peripheral nerve block
• Not having consent signed
• Prior use of strong opioids
• Unable to use PCA method
• Patients undergoing knee infiltration during the study.
• Patients diagnosed with chronic inflammatory arthritis (rheumatoid arthritis, for example) during the study.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Related Publications (14)

• 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.

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• 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.

  PMID: 27400891 BACKGROUND

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• 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.

  PMID: 29392204 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.

  PMID: 22923827 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.

  PMID: 25149364 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.

  PMID: 10365442 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.

  PMID: 21160232 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.

  PMID: 15561731 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.

  PMID: 10204446 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.

  PMID: 24634001 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.

  PMID: 22009383 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.

  PMID: 27027049 BACKGROUND

• 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.

  PMID: 34800495 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Metabolic Diseases; Osteoarthritis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• George Freire, MD

  University of São Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Livia Ab

CONTACT

1126612473; murmedicina@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor in Orthopedics and Traumatology

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 9, 2019
• Study Start: December 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: December 9, 2019

Record last verified: 2019-12