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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00210158
First Posted: September 21, 2005
Last Update Posted: July 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institut Bergonié
  Purpose
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 Intervention
Chronic Pain Procedure: Nitrous oxyde

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Institut Bergonié:

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)

Enrollment: 36
Study Start Date: January 2005
Study Completion Date: December 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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

ClinicalTrials.gov Identifier: NCT00210158     History of Changes
Other Study ID Numbers: IB2005-05
PROTOX
First Submitted: September 12, 2005
First Posted: September 21, 2005
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