Protocol summary
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Study aim
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Determining the effect of oral oxycodone for four weeks after surgery on pain and function of patients after primary knee replacement.
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Design
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Randomized (by sealdenvelope.com) controlled clinical trial, parallel groups, triple-blind, in phase II on 2 groups of 95 patients underwent complete knee replacement.
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Settings and conduct
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Patients undergoing complete knee replacement surgery at Imam Khomeini Hospital in Tehran were randomly divided into 2 groups of 95 (placebo and oxycodone) and the patient, physician and nurse were triple blinded not being aware of the prescribed drug by categorizing drug coding by another person not related to the study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Patients with knee osteoarthritis undergone total knee replacement
Exclusion criteria:
Drug and alcohol use, use of any other analgesics and antidepressants, and anti-epilepsy, previous history of surgery on the affected knee, intraoperative fracture, unwillingness of the patient to cooperate or continue follow-up, and bmi above 40 and Less than 20
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Intervention groups
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a triple-blind clinical trial in two groups of patients with knee osteoarthritis who underwent primary knee replacement surgery received standard analgesic therapy celecoxib (200 mg twice daily), acetaminophen (500 mg every 6 hours), and pregabalin (75 mg twice daily) from the time of surgery until discharge. After discharge, acetaminophen and celecoxib will be continued as needed for up to one month. Placebo is prescribed to the control group and oral oxycodone (5 mg) to the case group every 12 hours for four weeks.
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Main outcome variables
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knee pain, knee function, sleep quality, satisfaction, hospital length of stay
General information
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Reason for update
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The study protocol has been updated due to modifications in the study implementation method. The purpose of this update is to formally and accurately document the newly revised details related to the study design and execution. These revisions have been made with the aim of enhancing scientific accuracy, aligning with practical conditions, and improving the overall quality of the study.
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Acronym
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Faroxy TKA Trial
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IRCT registration information
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IRCT registration number:
IRCT20220413054520N1
Registration date:
2022-05-23, 1401/03/02
Registration timing:
prospective
Last update:
2025-07-18, 1404/04/27
Update count:
2
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Registration date
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2022-05-23, 1401/03/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-05-22, 1401/03/01
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Expected recruitment end date
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2023-05-22, 1402/03/01
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Actual recruitment start date
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2023-07-01, 1402/04/10
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Actual recruitment end date
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2024-07-01, 1403/04/11
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Trial completion date
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2025-01-25, 1403/11/06
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Scientific title
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Evaluation of the effectiveness of oral prescription of Oxycodone in comparison with standard analgesic treatment on postoperative pain and final function after knee replacement surgery
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Public title
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Effect of One-Month Oral Oxycodone on Postoperative Pain and Functional Recovery Following Total Knee Arthroplasty: A Randomized Clinical Trial
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of knee osteoarthritis requiring surgical intervention.
Undergo primary total knee arthroplasty.
Willingness and ability to provide informed consent.
Commitment to comply with the study protocol and complete follow-up.
Exclusion criteria:
Current use of antidepressants or antiepileptic drugs.
History of previous surgery on the affected knee.
Patients who were involved in this trial for their previous knee (bilateral TKAs), and/or participation in other clinical trials
Body Mass Index (BMI) > 40 or < 20.
Regular alcohol consumption.
Use of any analgesics not prescribed in the study protocol.
Known hypersensitivity or contraindication to oxycodone or any other medications in the standard analgesic regimen.
Severe hepatic or renal impairment (e.g., serum creatinine > 2.0 mg/dL, liver enzymes > 3 times the upper limit of normal).
Active infection or ongoing inflammatory conditions affecting the knee joint.
Psychiatric or cognitive conditions impairing the ability to comply with the study protocol.
Pregnancy or lactation.
Reluctance to cooperate or continue with follow-up.
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Age
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No age limit
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
190
Actual sample size reached:
190
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be randomized in a 1:1 ratio to receive either oxycodone or placebo. The study will be conducted in a triple-blind manner to ensure unbiased administration and assessment.
Once a patient has been deemed eligible and has provided written informed consent, randomization will be performed using the Sealedenvelope.com platform. To maintain the integrity of the triple-blind design, the randomization process will be conducted by a designated nurse who has no involvement in the study.
The randomization procedure involves assigning each patient a unique number, which is entered into the website. The website then allocates a randomized code corresponding to a pre-labeled box containing either oxycodone or placebo. Each box is pre-assigned a code by the software, and only the designated, uninvolved individual has access to the key that links codes to their respective contents. Patients will receive the study medication box corresponding to their assigned number.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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This trial will be conducted as a triple-blind study. Study drugs will be coded into two categories (placebo and oxycodone) by an independent third party with no involvement in the study.
Randomization will be performed using software to allocate treatment to patients without human intervention. Each participant will receive a numbered drug box, prepared according to the randomization software, containing either placebo or the active drug. Neither the patient, nurse, nor treating physician will be aware of the drug allocation (placebo or active drug) during the study. Additionally, the statistical analyst will also be blinded.
The treatment code will remain concealed until the data analysis is completed. Unblinding will only occur in cases of medical necessity or at the conclusion of the study, ensuring the integrity of the trial.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-10-29, 1400/08/07
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Ethics committee reference number
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IR.TUMS.IKHC.REC.1400.177
Health conditions studied
1
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Description of health condition studied
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Knee replacement surgery
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ICD-10 code
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M17
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ICD-10 code description
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Osteoarthritis of knee
Primary outcomes
1
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Description
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Patient's knee pain
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Timepoint
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1, 7, and 30 days post-surgery
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Method of measurement
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Visual Analogue Scale score
Secondary outcomes
1
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Description
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knee function and recovery
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Timepoint
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1 month and 6 months post-surgery
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Method of measurement
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Knee injury and Osteoarthritis Outcome Score (KOOS)
2
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Description
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knee function and recovery
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Timepoint
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1 month and 6 months post-surgery
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Method of measurement
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Oxford Knee Score (OKS)
3
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Description
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Sleep Quality
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Timepoint
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1 month post-surgery
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Method of measurement
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Pittsburgh Sleep Quality Index (PSQI)
4
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Description
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Satisfaction with the surgical outcome
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Timepoint
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6 months post-surgery
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Method of measurement
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scale from 0 to 10
5
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Description
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Hospital length of stay
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Timepoint
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During hospitalization
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Method of measurement
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Calculating the number of days of hospitalization after surgery
Intervention groups
1
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Description
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Intervention group: Oral immediate-release oxycodone hydrochloride 5 mg every 12 hours for 4 weeks post-op.
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Category
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Treatment - Drugs
2
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Description
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Control group: Matching placebo tablets on same schedule.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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All data will be shared after making patients in samples unidentifiable.
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When the data will become available and for how long
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With the publication of the article
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To whom data/document is available
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All Researchers
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Under which criteria data/document could be used
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Only statistical analysis is allowed
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From where data/document is obtainable
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as a supplementary
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What processes are involved for a request to access data/document
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All researchers will be given access
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Comments
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