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



Status:Active, not recruiting
Conditions:Back Pain, Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:July 2010
End Date:June 2016

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

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.


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
We found this trial at
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sites
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials