Photobiomodulation on Postoperative Pain
Maneno muhimu
Kikemikali
Maelezo
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.
Tarehe
| Imethibitishwa Mwisho: | 11/30/2019 |
| Iliyowasilishwa Kwanza: | 12/02/2019 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 12/04/2019 |
| Iliyotumwa Kwanza: | 12/08/2019 |
| Sasisho la Mwisho Liliwasilishwa: | 12/04/2019 |
| Sasisho la Mwisho Lilichapishwa: | 12/08/2019 |
| Tarehe halisi ya kuanza kwa masomo: | 11/30/2019 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 07/31/2020 |
| Tarehe ya Kukamilisha Utafiti: | 07/31/2020 |
Hali au ugonjwa
Uingiliaji / matibabu
Device: Experimental
Device: Control
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| 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: Experimental 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. |
| Active Comparator: Control 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: Control 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. |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 60 Years Kwa 60 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | 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. |
Matokeo
Hatua za Matokeo ya Msingi
1. Evaluate if photobiomodulation improves postoperative pain by VAS during hospital stay. [Day 2 after procedure]
Hatua za Matokeo ya Sekondari
1. Evaluate adverse events arising within 48 hours after surgery [Day 2 after procedure]
2. 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]
3. Measure time to first request for analgesia rescue after peripheral nerve block [Day 2 after procedure]
