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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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14 March 2016 |
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Main ID: |
NCT02689011 |
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Date of registration:
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07/02/2016 |
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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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Incidence of Urinary Retention in Patients Undergoing Unilateral Total Knee Arthroplasty- Comparison Between Continuous Epidural Analgesia and Single Shot Femoral Nerve Block- a Randomized Controlled Study (UriKANE)
UriKANE |
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Scientific title:
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Incidence of Urinary Retention in Patients Undergoing Unilateral Total Knee Arthroplasty- Comparison Between Continuous Epidural Analgesia and Single Shot Femoral Nerve Block- a Randomized Controlled Study (UriKANE) |
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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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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02689011 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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Phase:
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N/A
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Ausaf A Khan |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aga Khan University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ASA Physical status I, II & III
- Male and Female Patients age between between 30 and 70 years
- Unilateral Total Knee Arthroplasty
Exclusion Criteria:
- Patient Refusal
- Allergy to local anesthetics, paracetamol or other study drugs
- History of opioid dependence
- Contraindications to spinal/epidural anesthesia and femoral nerve block (coagulation
defects, infection at puncture site etc.)
- Inability to use patient-controlled analgesia (IV PCIA) (as assessed at the time of
informed consent)
- History of urinary retention, neurogenic bladder, or any urologic problem
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Post Operative Pain
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Acute Pain
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Urinary Retention
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Intervention(s)
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Procedure: Epidural
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Procedure: Femoral Nerve Block
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Primary Outcome(s)
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Incidence of urinary retention
[Time Frame: 24 Hours]
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Secondary Outcome(s)
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Surgical outcomes - mobilization out of bed
[Time Frame: up to 48 hours]
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Mean post-operative pain scores
[Time Frame: up to 48 hours]
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Mean post-operative sedation scores
[Time Frame: up to 48 hours]
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Patient satisfaction
[Time Frame: 7 Days]
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Surgical outcomes - food intake
[Time Frame: up to 48 hours]
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Surgical outcomes - duration of post-operative hospital stay
[Time Frame: up to 48 hours]
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Mean post-operative nausea and vomiting scores
[Time Frame: up to 48 hours]
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Surgical outcomes - maximal knee flexion
[Time Frame: up to 48 hours]
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Secondary ID(s)
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CTU / UriKANE / 2013
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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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