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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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29 June 2015 |
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Main ID: |
NCT02200016 |
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Date of registration:
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23/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Displacement of Popliteal Sciatic Nerve Catheters After Major Foot and Ankle Surgery
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Scientific title:
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Date of first enrolment:
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November 2014 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02200016 |
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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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic
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Phase:
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Phase 4
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Countries of recruitment
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Denmark
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age = 18 y.
- Major foot and ankle surgery postoperativ pain treatment with sciatic nerve catheter
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- Written and informed concent
Exclusion Criteria:
- Patient uanble to cooperate
- Patients not speaking and understanding Danish or English
- Patiens in immunosuppresive treatment
- Patienter with neuropathys in lower extremities
- Allergies to the in the protocole listes medicines
- A daily opoid intake
- Pregnant women
- Patients not meeting MR-criterias (metal, claustofobia...)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Regional Anesthesia
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Postoperative Pain
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Intervention(s)
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Procedure: Ultrasound guided long axis (LAX) placement of sciatic nerve catheters
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Device: B Braun Contiplex S catheter
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Procedure: Ultrasound guided short axis (SAX) placement of sciatic nerve catheters
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Primary Outcome(s)
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Frequency of nerve catheter displacement
[Time Frame: 48 hours after catheter placement]
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Secondary Outcome(s)
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Opioid comsumption
[Time Frame: Within first 48 hours postoperatively]
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MR evaluated distribution of local anesthetic after injection MR-contrast
[Time Frame: 48 hours after catheter placement]
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Postoperativ pain after local anesthetic injection via sciatic nerve catheter
[Time Frame: Within 48 hours postoperatively]
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Number of rescue blocks
[Time Frame: Within 48 hours postoperatively]
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Secondary ID(s)
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2014-000707-28
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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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