Intraoperative Nitrous Oxide and Postoperative Pain for Patients With Current Opioid Treatment - Full Text View

Sponsored by:	Institut Bergonié
Information provided by:	Institut Bergonié
ClinicalTrials.gov Identifier:	NCT00210158

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

Drug Information available for: Nitrous oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Intraoperative Nitrous Oxide on Postoperative Pain for Patients With Current Opioid Treatment After Vertebroplasty.

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

Study ID Numbers:	IB2005-05, PROTOX
Study First Received:	September 12, 2005
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00210158
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Bergonié:

Current opioid treatment
Nitrous oxide
Chronic pain

Opioid therapy
Postoperative hyperalgesia
Acute opioid tolerance

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Nitrous Oxide

Pain
Hyperalgesia
Pain, Postoperative

Additional relevant MeSH terms:

Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
Anesthetics, Inhalation
Pathologic Processes
Analgesics, Non-Narcotic

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009