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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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19 February 2015 |
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Main ID: |
NCT01704612 |
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Date of registration:
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07/10/2012 |
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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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Evaluation of Block Duration in Type 2 Diabetes Patients
Diabeteblock |
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Scientific title:
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Comparison of Subgluteal Sciatic Nerve Block Duration in Type-2 Diabetic and Non Diabetic Patients |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01704612 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Philippe Cuvillon, 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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APHP Pitié Salpetriere |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age (50 80 yrs) with monofilament test 10 g (> 4/8)
Exclusion Criteria:
- refusal of sciatic nerve block,
- age < 50 yr or > 80 yr,
- American Society of Anesthesiologists state > IV,
- presence of contraindications to local anaesthesia (known allergy to local
anaesthetics, sepsis),
- emergency surgery,
- patients unlikely to be fully cooperative during the study,
- psychiatric disorders, or
- those abusing alcohol or drugs, and
- participation in another study within the previous 30 days. Moreover, patients with
preoperative estimated values of creatinine clearance < 50 mL min-1 (Cockroft and
Gault Formula) or with glycosylated hemoglobin (A1c) level > 8 % or with type 1
diabetes mellitus (insulin therapy)
Age minimum:
50 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Type 2
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Intervention(s)
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Drug: ropivacaine
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Primary Outcome(s)
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the duration of sensory block in hours
[Time Frame: Day 0]
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Secondary Outcome(s)
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the duration of motor sciatic block
[Time Frame: Day 0]
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Secondary ID(s)
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2011-PC001
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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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