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Phase 2 N=39 Randomized Triple-blind Treatment

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

Chronic Pain

Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Post-operative Morphine Consumption — 54.6; 44.8 mg — p=0.5

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Air (Procedure); Protox (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Institut Bergonié
Primary completion
Dec 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
Post-operative Morphine Consumption
54.6; 44.8 0.5
SECONDARY
Proportion of Participants With Post-operative Pain
2; 1

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.

Eligibility Criteria

  • Older than 18 years
  • Current opioid treatment > 1 month
  • patients scheduled to undergo vertebroplasty with general anesthesia
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00210158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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