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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entonox | Active Comparator | Patients will receive inhaled Entonox along with the interventional block they are scheduled. |
|
| Oxygen | Placebo Comparator | Patients will receive inhaled oxygen along with the interventional block they are scheduled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entonox | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alparslan Turan, M.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Entonox | Patients will receive inhaled Entonox along with the interventional block they are scheduled. Entonox: 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. |
| FG001 | Oxygen | Patients will receive inhaled oxygen along with the interventional block they are scheduled. Oxygen: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entonox | Patients will receive inhaled Entonox along with the interventional block they are scheduled. Entonox: 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | For 10 patients with missing VAS at 3 month follow up: 5 patients who had 2nd or 3rd epidural block, we assigned the last VAS observation (i.e., from VAS before 2nd or 3rd block to 3 month follow-up); and for 5 patients who only had 1st epidural, we assigned the worst VAS (10) for Entonox patients and the best VAS (0) for Oxygen patients. | Posted | Mean | Standard Deviation | units on a scale | 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) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Entonox | Patients will receive inhaled Entonox along with the interventional block they are scheduled. Entonox: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alparslan Turan, MD | Cleveland Clinic | 216-445-9857 | turana@ccf.org |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C001147 | Entonox |
| D009609 | Nitrous Oxide |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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|
| Oxygen | Other | 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. |
|
| 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) |
| Oxygen |
Patients will receive inhaled oxygen along with the interventional block they are scheduled. Oxygen: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Body mass index | Median | Inter-Quartile Range | kg/m2 |
|
| American Society of Anesthesiologists physical status | Number | participants |
|
| Smoking status | Number | participants |
|
Patients will receive inhaled Entonox along with the interventional block they are scheduled.
Entonox: 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.
| OG001 | Oxygen | Patients will receive inhaled oxygen along with the interventional block they are scheduled. Oxygen: 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. |
|
|
|
| Primary | 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. | 10 patients in the Entonox group and 11 patients in the Oxygen group did not receive the 2nd block treatment | Posted | Mean | Standard Deviation | units on a scale | At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline |
|
|
|
|
| Primary | 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 | 21 patients in the Entonox group and 26 patients in the Oxygen group did not receive the 2nd block treatment | Posted | Mean | Standard Deviation | units on a scale | At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline |
|
|
|
|
| Secondary | 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. | 10 Entonox patients and 11 Oxygen patients did not receive 2nd block. | Posted | Mean | Standard Deviation | absolute percentage | At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline |
|
|
|
| Secondary | 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. | 21 Entonox patients and 26 Oxygen patients did not receive 3rd block. | Posted | Mean | Standard Deviation | absolute percentage | At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline |
|
|
|
| Secondary | 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. | 5 patients in each group were lost follow-up. | Posted | Mean | Standard Deviation | absolute percentage | 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) |
|
|
|
| Secondary | Usage of Opioids | 10 Entonox patients and 11 Oxygen patients did not receive 2nd block. | Posted | Number | participants | 2nd block, typically at 1 month from baseline |
|
|
|
| Secondary | Usage of Opioid | 21 Entonox patients and 26 Oxygen patients did not receive 2nd block. | Posted | Number | participants | 3rd block, typically at 2 months from baseline |
|
|
|
| Secondary | Usage of Opioid | 5 patients in each group were lost follow up. | Posted | Number | participants | 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks) |
|
|
|
| Secondary | Biomarkers | BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α | Blood sample was not collected for 5 Entonox patients and 1 Oxygen patients. | Posted | Median | Inter-Quartile Range | pg/ml | baseline - before 1st block |
|
|
|
| Secondary | Biomarkers | BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α | 10 Entonox patients and 11 Oxygen patients did not come for 2nd block. Among patients came for the 2nd block, blood sample was not collected in 9 Entonox patients and 6 Oxygen patients. | Posted | Median | Inter-Quartile Range | pg/ml | before 2nd block, typically at 1 month from baseline |
|
|
|
| Secondary | Biomarkers | BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α | 21 Entonox patients and 26 Oxygen patients did come for the 3rd block. Among the patients who came for the 3rd block, blood sample was not collected in 5 Entonox patients and 1 Oxygen patient. | Posted | Median | Inter-Quartile Range | pg/ml | before 3rd block, typically at 2 months from baseline |
|
|
|
| Secondary | Biomarkers | BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α | No blood sample was planned to be collected. | Posted | 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks) |
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Oxygen | Patients will receive inhaled oxygen along with the interventional block they are scheduled. Oxygen: 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. | 0 | 39 | 0 | 39 |
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| D010087 |
| Oxides |
| D017601 | Oxygen Compounds |
| D018011 | Chalcogens |
| D004602 | Elements |
| IL-10 |
|
| IL-17A |
|
| IFN-γ |
|
| TNF-α |
|
| IL-10 |
|
| IL-17A |
|
| IFN-γ |
|
| TNF-α |
|
| IL-10 |
|
| IL-17A |
|
| IFN-γ |
|
| TNF-α |
|