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

This study has been completed.
Sponsor:
Information provided by:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT00210158
First received: September 12, 2005
Last updated: December 29, 2011
Last verified: October 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

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)

Estimated Enrollment: 40
Study Start Date: January 2005
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00210158     History of Changes
Other Study ID Numbers: IB2005-05, PROTOX
Study First Received: September 12, 2005
Last Updated: December 29, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Nitrous Oxide
Analgesics, Opioid
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 23, 2013