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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00210158 |
Date of registration:
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12/09/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Intraoperative Nitrous Oxide and Postoperative Pain for Patients With Current Opioid Treatment
PROTOX |
Scientific title:
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Effects of Intraoperative Nitrous Oxide on Postoperative Pain for Patients With Current Opioid Treatment After Vertebroplasty. |
Date of first enrolment:
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January 2005 |
Target sample size:
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36 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00210158 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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N/A
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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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Fabrice LAKDJA, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest |
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Key inclusion & exclusion criteria
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Inclusion criteria:
> 18 years old Current opioid treatment > 1 month patients scheduled to undergo
vertebroplasty with general anesthesia
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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Chronic Pain
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Intervention(s)
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Procedure: Nitrous oxyde
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Primary Outcome(s)
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Visual Analogue Scale (VAS) and morphine consumption recorded for 48 postoperative hours (every 8 hours).
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Secondary Outcome(s)
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Preoperative and postoperative pressure pain threshold (pressure algometer)
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Secondary ID(s)
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IB2005-05
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PROTOX
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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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