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Photobiomodulation on Postoperative Pain

NCT04190797 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-12-09

No results posted yet for this study

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

Interventions

DEVICE

Photobiomodulation + patiente controled anaethesia (PCA)

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

Placebo + patiente controled anaethesia (PCA)

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.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • George Freire, MD · University of São Paulo General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2020-08-01
Completion
2020-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04190797 on ClinicalTrials.gov