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

NCT ID: NCT00210158

Last Updated: 2025-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-01

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Air arm (Reference)

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

Group Type SHAM_COMPARATOR

Air

Intervention Type PROCEDURE

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

Protox Arm (Experimental)

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

Group Type EXPERIMENTAL

Protox

Intervention Type PROCEDURE

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

Interventions

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Air

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

Intervention Type PROCEDURE

Protox

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Older than 18 years
* Current opioid treatment \> 1 month
* patients scheduled to undergo vertebroplasty with general anesthesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Bergonié

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabrice Lakdja, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Bergonié

Locations

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

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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IB2005-05

Identifier Type: -

Identifier Source: org_study_id

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