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Inhalational Anesthetic

The nitrous oxide group for Complex Regional Pain Syndrome

Phase 3
Waitlist Available
Led By Jason Hale, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Duration of disease must be at least 6 months.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one-week and one-month follow-up time points
Awards & highlights

Study Summary

This trial is testing whether nitrous oxide is better than oxygen at reducing pain for people with a spinal cord stimulator.

Eligible Conditions
  • Complex Regional Pain Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must have had the disease for at least 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one-week and one-month follow-ups.
This trial's timeline: 3 weeks for screening, Varies for treatment, and one-week and one-month follow-ups. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain Score
Secondary outcome measures
PGIC Scale
PROMIS-29 Survey Physical Health Z-score, Mental Health Z-score

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: The nitrous oxide groupActive Control1 Intervention
Nitrous oxide group will receive 50% nitrous oxide mixed with 50% oxygen, inhalation therapy for a duration of 2 hours via an FDA-approved mask breathing circuit.
Group II: The Control GroupPlacebo Group1 Intervention
Control group will receive 50% oxygen, inhalation therapy for a duration of 2 hours via an FDA-approved mask breathing circuit.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,019 Previous Clinical Trials
1,365,031 Total Patients Enrolled
Jason Hale, MDPrincipal InvestigatorAnesthesiologist

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study only open to individuals who are under 30 years old?

"According to the age limits set out in this clinical trial's eligibility criteria, patients must be between 18 and 65 years old."

Answered by AI

Who meets the criteria to take part in this experiment?

"Up to 44 individuals between the ages of 18-65 who have Complex Regional Pain Syndrome (CRPS) also known as Reflex Sympathetic Dystrophy (RSD) can be admitted into this trial. Importantly, these patients must have had RSD for a minimum of 6 months."

Answered by AI

What medical conditions respond best to nitrous oxide therapy?

"Analgesia is commonly managed with nitrous oxide. Additionally, this gas can be used to mitigate other conditions like hypoxemia, general anesthesia, and anemia."

Answered by AI

Are there risks associated with The nitrous oxide group?

"There is both prior clinical data supporting the safety of nitrous oxide and multiple rounds of supportive data, so it received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Indiana
Ohio
How old are they?
18 - 65
What site did they apply to?
Cleveland Clinic Pain Management
What portion of applicants met pre-screening criteria?
Met criteria
~8 spots leftby Mar 2025