Effect of Nitrous Oxide in Treating Neuropathic Pain: A Study in Chronic Low Back Pain Patients

Study Overview
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Brief Summary
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Epidural injection will be completed under fluoroscopy and all patients will receive 1-4 mg of Midazolam for relaxation before procedure and, if needed, 50-100 mcg of Fentanyl intravenous (IV). Radiopaque contrast (Omnipaque 300), for confirming the epidural position of the needle, steroids and local anesthetic agents will be used according to the physician performing the block and will not be controlled by the study. Patients will be randomly assigned to receive either inhaled Entonox along with the interventional block they are scheduled for or oxygen. They will be blinded about the treatment they are receiving. Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery. Those randomized to the oxygen group will receive oxygen through a similar mouthpiece for the entire duration of the procedure and recovery for 4 hours. Following completion of procedure the patient will be transferred to recovery and monitored for 3-5 hours then discharged home with instructions. Possible side effects will be monitored and recorded, pain score of patient will be recorded before discharge. All the patients will receive standard instructions regarding physical back exercises. This will be repeated for every procedure up to maximum of three blocks. The patients will be followed during each block and over a period of 1, 3, 6 and 12 months and on each follow-up visit will complete computerized set of questionnaires as they did before the procedure. The patients charts will be then reviewed for one year after the initial procedure to determine if further epidural steroid injections or surgery for the presenting problem were required. It is anticipated that the appropriate number of patients will be enrolled within six months of study initiation.

Official Title
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Effect of Nitrous Oxide in Treating Neuropathic Pain: A Pilot Study in Chronic Low Back Pain Patients

Conditions
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Low Back Pain, Radiating Pain

Intervention / Treatment
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* Other: Entonox
* Other: Oxygen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 80 years old at time of the first procedure Male or female History of chronic low back pain for longer than 6 months due to radiculopathy, symptomatic spinal canal stenosis, disc prolapse, postlaminectomy syndrome magnetic resonance imaging or electromyographic evidence of nerve root damage Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score of >12 No or minimal evidence of facet joint pathology Exclusion Criteria: Known contraindications for epidural injection Patients with ongoing workers' compensation claims unstable or heavy opioid use (400 mg of morphine equivalents daily), psychiatric disorders medical illness, including conditions that could interfere with the interpretation of the outcome assessments pregnant or lactating women Current or recent drug abuse (within past 6 months). Patient refuses regional analgesia. Alcohol or drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Entonox<br>Patients will receive inhaled Entonox along with the interventional block they are scheduled. | Other: Entonox<br>* Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery.<br>* Other names: Nitrous Oxide;|
| Placebo Comparator: Oxygen<br>Patients will receive inhaled oxygen along with the interventional block they are scheduled. | Other: Oxygen<br>* Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VAS Pain Score From Baseline to 3 Month Follow-up | 10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up. The primary outcome was the change in VAS pain score from baseline (before 1st block) to the 3 month follow-up. | At baseline (before 1st block) and 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks) | 
| Change in VAS Pain Score From Baseline to Before 2nd Block | 10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up. The primary outcome was the change in VAS pain score from baseline (before 1st block) to before the 2nd block. | At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline | 
| Change in VAS Pain Score From Baseline to Before 3rd Block | 10-cm-long Visual Analog Scale (VAS) pain score, ranges from 0 (no pain) to 10 (worst pain imaginable). It was measured before 1st 2nd and 3rd block and at 3 month follow-up. The primary outcome was the change in VAS pain score from baseline (before 1st block) to before the 3rd block | At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oswestry Score (% of Disability) From Baseline to 2nd Block | Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to before 2nd block. | At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline | 
| Change in Oswestry Score (% of Disability) From Baseline to 3rd Block | Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to before 3rd block. | At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline | 
| Change in Oswestry Score (% of Disability) From Baseline to 3 Months Follow-up | Oswestry score ranges from 0% to 100%, which measures % of disability. The outcome is change in the Oswestry score from baseline (before 1st block) to 3 months follow-up. | At baseline (before 1st block) and 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks) | 
| Usage of Opioids |  | 2nd block, typically at 1 month from baseline | 
| Usage of Opioid |  | 3rd block, typically at 2 months from baseline | 
| Usage of Opioid |  | 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks) | 
| Biomarkers | BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α | baseline - before 1st block | 
| Biomarkers | BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α | before 2nd block, typically at 1 month from baseline | 
| Biomarkers | BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α | before 3rd block, typically at 2 months from baseline | 
| Biomarkers | BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α | 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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steroid, radiating back pain, epidural block, recurrent low back pain, Lumbar Epidural Steroid Block with 3 injections