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Main
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Note: This record shows only the 20 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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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR990 |
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Date of registration:
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31/05/2007 |
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Primary sponsor: |
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Public title:
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The efficacy of levobupivacaine, ropivacaine and bupivacaine for combined psoas compartment - sciatic nerve block in patients undergoing total hip replacement.
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Scientific title:
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The efficacy of levobupivacaine, ropivacaine and bupivacaine for combined psoas compartment - sciatic nerve block in patients undergoing total hip replacement. - The efficacy of levobupivacaine, ropivacaine and bupivacaine for combined psoas compartment - sciatic nerve block in patients undergoing total hip replacement. |
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Date of first enrolment:
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1/6/2003 |
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Target sample size:
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45 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=990 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Not applicable; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Roberto S.G.M.
Perez |
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Address:
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VU medisch centrum, Anesthesiologie
postbus 7057
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+31 20-4440029. |
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Email:
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rsgm.perez@vumc.nl |
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Affiliation:
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Name:
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Marcel A
Leeuw, de |
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Address:
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Zaans Medical Center
Department of Anesthesiology, Koningin Julianaplein 58
1502 DV
Zaanstad
The Netherlands |
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Telephone:
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+ 31 75-6425529 |
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Email:
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ma.deleeuw@planet.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age above 18;
2. ASA classification I-III;
3. Total Hip Replacement under general anesthesia.
Exclusion criteria: 1. Co-agulation disorders;
2. Infections at puncture sites;
3. Known allergy to local anesthetics;
4. Pre-existing neurological dysfunction;
5. Not been able to proper communication.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Total hip replacement, Psoas compartment block, Sciatic nerve block
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Intervention(s)
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Psoas Compartment - Sciatic Nerve Block given with Bupivacaine, Levobupivacaine or Ropivacaine. Duration of the intervention: 10 min.
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Primary Outcome(s)
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Pain (Visual Analog Scale) op T = 4,8,12,24,48 hour post - puncture.
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Secondary Outcome(s)
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1. Degree of motor block (Modified Bromage Scale).op T = 4,8,12,24,48 hour post - puncture;
2. Degree of sensory block (Loss of pin-prick sensation in leg dermatomes) op T = 4,8,12,24,48 hour post - puncture.
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Secondary ID(s)
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ISRCTN16416351
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Source(s) of Monetary Support
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VU University Medical Center, Department of Anesthesiology
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