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NCT00210158 Clinical Trial

Intraoperative Nitrous Oxide and Postoperative Pain for Patients With Current Opioid Treatment

Chronic Pain Clinical Trial

— PROTOX  

Official title:
Effects of Intraoperative Nitrous Oxide on Postoperative Pain for Patients With Current Opioid Treatment After Vertebroplasty.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00210158
Other study ID # IB2005-05
Secondary ID PROTOX
Status Completed
Phase N/A
First received September 12, 2005
Last updated July 25, 2013
Start date January 2005
Est. completion date December 2006

Study information
Verified date October 2007
Source Institut Bergonié
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

> 18 years old Current opioid treatment > 1 month patients scheduled to undergo vertebroplasty with general anesthesia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Nitrous oxyde

Locations
Country Name City State
France Institut Bergonié - Centre Régional de Luttre Contre le Cancer DE Bordeaux et du Sud Ouest Bordeaux

Sponsors (1)
Lead Sponsor Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale (VAS) and morphine consumption recorded for 48 postoperative hours (every 8 hours).
Secondary Preoperative and postoperative pressure pain threshold (pressure algometer)
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