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

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ClinicalTrials.gov Identifier: NCT00210158
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : July 26, 2013
Sponsor:
Information provided by:
Institut Bergonié

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Pain Procedure: Nitrous oxyde Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Intraoperative Nitrous Oxide on Postoperative Pain for Patients With Current Opioid Treatment After Vertebroplasty.
Study Start Date : January 2005
Actual Study Completion Date : December 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) and morphine consumption recorded for 48 postoperative hours (every 8 hours).

Secondary Outcome Measures :
  1. Preoperative and postoperative pressure pain threshold (pressure algometer)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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

Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210158


Locations
France
Institut Bergonié - Centre Régional de Luttre Contre le Cancer DE Bordeaux et du Sud Ouest
Bordeaux, France, 33076
Sponsors and Collaborators
Institut Bergonié
Investigators
Principal Investigator: Fabrice LAKDJA, MD Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
More Information
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ClinicalTrials.gov Identifier: NCT00210158     History of Changes
Other Study ID Numbers: IB2005-05
PROTOX
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: July 26, 2013
Last Verified: October 2007

Keywords provided by Institut Bergonié:
Current opioid treatment
Nitrous oxide
Chronic pain
 Opioid therapy
Postoperative hyperalgesia
Acute opioid tolerance

Additional relevant MeSH terms:
Pain, Postoperative
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Nitrous Oxide
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic