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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 September 2015 |
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Main ID: |
NCT02534610 |
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Date of registration:
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20/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Analgesic Benefit of Preoperative vs. Postoperative Etoricoxib in Total Knee Arthroplasty
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Scientific title:
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Is There Any Analgesic Benefit From Preoperative vs. Postoperative Etoricoxib Administration in Total Knee Arthroplasty? |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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165 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02534610 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Romania
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Contacts
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Name:
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Munteanu Ana-Maria, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Foisor Orthopedics Clinical Hospital Bucharest |
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Name:
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Stoica I Cristian, MD, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Foisor Orthopedics Clinical Hospital Bucharest |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ASA I-III
- weight (kilos) over 40 kg
- height (centimeters) over 155 cm
- non-anemic
- indication for primary TKA (total knee arthroplasty)
Exclusion Criteria:
- history of asthma
- peptic ulcer
- severe hepatic or renal dysfunction
- neuropathies
- bleeding disorders
- uncooperative
- drug abuse
- sensibility to etoricoxib
- paracetamol or morphine
- long acting nonsteroidal antiinflammatory drugs (NSAID) in the last 4 days
preoperative
- cerebrovascular and peripheric vascular disease
- arterial hypertension (HTA) not adequately controlled
- congestive heart failure.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postoperative Pain
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Intervention(s)
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Drug: Etoricoxib
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Drug: Placebo
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Primary Outcome(s)
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Total morphine consumption
[Time Frame: At 48 hour postoperative]
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Secondary Outcome(s)
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Duration of analgesia
[Time Frame: At 48 hours postoperative]
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Number of patients with side effects of drugs used
[Time Frame: 48 hour postoperative]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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