Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
NCT Number: NCT01172600
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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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Nitrous Oxide
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.
Time frame: 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)
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.
Time frame: At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline
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.
Time frame: At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline
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
Time frame: At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline
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.
Time frame: At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline
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.
Time frame: 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)
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.
Time frame: 2nd block, typically at 1 month from baseline
Time frame: 3rd block, typically at 2 months from baseline
Time frame: 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)
Time frame: baseline - before 1st block
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
Time frame: before 2nd block, typically at 1 month from baseline
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
Time frame: before 3rd block, typically at 2 months from baseline
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
Time frame: 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks)
BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α
The Cleveland Clinic
Other
Effect of Nitrous Oxide in Treating Neuropathic Pain: A Pilot Study in Chronic Low Back Pain Patients
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