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Photobiomodulation on Postoperative Pain

Primary Purpose

Knee Osteoarthritis, Metabolic Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photobiomodulation + patiente controled anaethesia (PCA)
Placebo + patiente controled anaethesia (PCA)
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Laser Therapy, Osteoarthritis, Knee

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Evaluate if photobiomodulation improves postoperative pain by VAS during hospital stay.
    Apply the VAS (Visual Analog Scale), range: 0 no pain - 100 worse pain

    Secondary Outcome Measures

    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)
    Evaluate morphine consumption in a patient-controlled analgesia device (PCA) from the immediate postoperative period up to 48h after the procedure
    Through the patient-controlled analgesia (PCA) method
    Measure time to first request for analgesia rescue after peripheral nerve block
    Through the patient-controlled analgesia (PCA) method

    Full Information

    First Posted
    December 3, 2019
    Last Updated
    December 5, 2019
    Sponsor
    University of Sao Paulo General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04190797
    Brief Title
    Photobiomodulation on Postoperative Pain
    Official Title
    Photobiomodulation on Postoperative Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2019 (Anticipated)
    Primary Completion Date
    August 1, 2020 (Anticipated)
    Study Completion Date
    August 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    thirty-four patients treated at the Institute of Orthopedics and Traumatology, University of São Paulo School of Medicine Hospital das Clínicas (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: Photobiomodulation + PCA Group (G1): patients in the PO of knee arthroplasty surgery treated with the photobiomodulation device turned on, 24h and 48h after peripheral nerve block (femoral nerve and obturator nerve) .With conventional analgesia and with the device of PCA. Placebo + PCA group (G2): patients in the postoperative period of knee arthroplasty surgery treated with the photobiomodulation device switched off at 24h and 48h after peripheral nerve block (femoral nerve and obturator nerve). With conventional analgesia and with the PCA device. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis, Metabolic Disease
    Keywords
    Laser Therapy, Osteoarthritis, Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Photobiomodulation + patiente controled anaethesia (PCA)
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Placebo + patiente controled anaethesia (PCA)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Evaluate if photobiomodulation improves postoperative pain by VAS during hospital stay.
    Description
    Apply the VAS (Visual Analog Scale), range: 0 no pain - 100 worse pain
    Time Frame
    Day 2 after procedure
    Secondary Outcome Measure Information:
    Title
    Evaluate adverse events arising within 48 hours after surgery
    Description
    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)
    Time Frame
    Day 2 after procedure
    Title
    Evaluate morphine consumption in a patient-controlled analgesia device (PCA) from the immediate postoperative period up to 48h after the procedure
    Description
    Through the patient-controlled analgesia (PCA) method
    Time Frame
    Day 2 after procedure
    Title
    Measure time to first request for analgesia rescue after peripheral nerve block
    Description
    Through the patient-controlled analgesia (PCA) method
    Time Frame
    Day 2 after procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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) Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Livia Ab
    Phone
    1126612473
    Email
    murmedicina@outlook.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    George Freire, MD
    Organizational Affiliation
    University of São Paulo General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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