NCT00210158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2 chronic-pain

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2006

Completed
18.7 years until next milestone

Results Posted

Study results publicly available

September 9, 2025

Completed
Last Updated

September 9, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

September 12, 2005

Results QC Date

August 20, 2025

Last Update Submit

August 20, 2025

Conditions

Chronic Pain

Keywords

Current opioid treatmentNitrous oxideChronic painOpioid therapyPostoperative hyperalgesiaAcute opioid tolerance

Outcome Measures

Primary Outcomes (1)

  • Post-operative Morphine Consumption

    Morphine consumption (mg) during PCA (Patient Controlled Analgesia)

    Between surgery and up to 48 hours

Secondary Outcomes (1)

  • Proportion of Participants With Post-operative Pain

    Between surgery and up to 48 hours

Study Arms (2)

Air arm (Reference)

SHAM COMPARATOR

Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.

Procedure: Air

Protox Arm (Experimental)

EXPERIMENTAL

Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.

Procedure: Protox

Interventions

AirPROCEDURE

Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.

Air arm (Reference)
ProtoxPROCEDURE

Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.

Protox Arm (Experimental)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Older than 18 years * Current opioid treatment \> 1 month * patients scheduled to undergo vertebroplasty with general anesthesia

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Institut Bergonié - Centre Régional de Luttre Contre le Cancer DE Bordeaux et du Sud Ouest

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

AirProtoporphyrinogen Oxidase

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public HealthOxidoreductases Acting on CH-CH Group DonorsOxidoreductasesEnzymesEnzymes and CoenzymesMembrane ProteinsProteinsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Simone Mathoulin-Pélissier, Director of Clinical Trials Unit
Organization
Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR
s.mathoulin@bordeaux.unicancer.fr
+33 5 56 33 33 33

Study Officials

  • Fabrice Lakdja, MD

    Institut Bergonié

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

January 1, 2005

Primary Completion

December 31, 2006

Study Completion

December 31, 2006

Last Updated

September 9, 2025

Results First Posted

September 9, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)