Photobiomodulation on Postoperative Pain

December 5, 2019 updated by: Marcia Uchoa Rezende, University of Sao Paulo General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate if photobiomodulation improves postoperative pain by VAS during hospital stay.
Time Frame: Day 2 after procedure
Apply the VAS (Visual Analog Scale), range: 0 no pain - 100 worse pain
Day 2 after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate adverse events arising within 48 hours after surgery
Time Frame: Day 2 after procedure
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)
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
Time Frame: Day 2 after procedure
Through the patient-controlled analgesia (PCA) method
Day 2 after procedure
Measure time to first request for analgesia rescue after peripheral nerve block
Time Frame: Day 2 after procedure
Through the patient-controlled analgesia (PCA) method
Day 2 after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: George Freire, MD, University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (Actual)

December 9, 2019

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 5, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23338619.4.0000.0068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe