Photobiomodulation on Postoperative Pain
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Knee Osteoarthritis
- Metabolic Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 60 years and 75 years
- Gender
- Both males and females
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 gro...
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.
Tracking Information
- NCT #
- NCT04190797
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: George Freire, MD University of São Paulo General Hospital