Back to resultsIntraoperative Nitrous Oxide and Postoperative Pain for Patients With Current Opioid Treatment (PROTOX)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nitrous oxyde
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Current opioid treatment, Nitrous oxide, Chronic pain, Opioid therapy, Postoperative hyperalgesia, Acute opioid tolerance
Eligibility Criteria
Inclusion criteria: > 18 years old Current opioid treatment > 1 month patients scheduled to undergo vertebroplasty with general anesthesia
Sites / Locations
- Institut Bergonié - Centre Régional de Luttre Contre le Cancer DE Bordeaux et du Sud Ouest
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS) and morphine consumption recorded for 48 postoperative hours (every 8 hours).
Secondary Outcome Measures
Preoperative and postoperative pressure pain threshold (pressure algometer)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00210158
Brief Title
Intraoperative Nitrous Oxide and Postoperative Pain for Patients With Current Opioid Treatment
Acronym
PROTOX
Official Title
Effects of Intraoperative Nitrous Oxide on Postoperative Pain for Patients With Current Opioid Treatment After Vertebroplasty.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institut Bergonié
4. Oversight
5. Study Description
Brief Summary
Peroperative opioids are known to induce N-Methyl-D-Aspartate dependent enhancement of postoperative hyperalgesia. For patients with current opioid treatment, these phenomena could be exagerated and could produce greater postoperative opioid consumption and higher pain score. Since Nitrous oxide has anti- N-Methyl-D-Aspartate properties, the aim of this study was to evaluate, in patients with current opioid treatment, the effects of peroperative Nitous oxide on postoperative opioid consumption and pain score, after vertebroplasty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Current opioid treatment, Nitrous oxide, Chronic pain, Opioid therapy, Postoperative hyperalgesia, Acute opioid tolerance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Nitrous oxyde
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) and morphine consumption recorded for 48 postoperative hours (every 8 hours).
Secondary Outcome Measure Information:
Title
Preoperative and postoperative pressure pain threshold (pressure algometer)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
> 18 years old Current opioid treatment > 1 month patients scheduled to undergo vertebroplasty with general anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice LAKDJA, MD
Organizational Affiliation
Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Bergonié - Centre Régional de Luttre Contre le Cancer DE Bordeaux et du Sud Ouest
City
Bordeaux
ZIP/Postal Code
33076
Country
France
12. IPD Sharing Statement
Learn more about this trial
Intraoperative Nitrous Oxide and Postoperative Pain for Patients With Current Opioid Treatment
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