Effect of Nitrous Oxide in Treating Neuropathic Pain: A Study in Chronic Low Back Pain Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Low Back Pain Radiating Pain |
Other: Entonox Other: Oxygen |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Supportive Care |
| Official Title: | Effect of Nitrous Oxide in Treating Neuropathic Pain: A Pilot Study in Chronic Low Back Pain Patients |
- Pain relief [ Time Frame: 30 days post treatment ] [ Designated as safety issue: No ]Pain relief on Visual Analog Scale (VAS), beginning one month after the procedure defined as a difference of 15 mm or less.
- Pain Relief [ Time Frame: 3 mos. post treatment ] [ Designated as safety issue: No ]Pain relief on Visual Analog Scale (VAS), beginning one month after the procedure defined as a difference of 15 mm or less.
- Pain Relief [ Time Frame: 6 mos. post treatment ] [ Designated as safety issue: No ]Pain relief on Visual Analog Scale (VAS), beginning one month after the procedure defined as a difference of 15 mm or less.
- Functional capacity [ Time Frame: 30 days post treatment ] [ Designated as safety issue: No ]Significant improvement in patient's functional capacity, defined by an Oswestry score difference <10%, in patients given nitrous oxide treatment along with interventional block.
- Functional Capacity [ Time Frame: 3 most post treatment ] [ Designated as safety issue: No ]Significant improvement in patient's functional capacity, defined by an Oswestry score difference <10%, in patients given nitrous oxide treatment along with interventional block.
- Functional Capacity [ Time Frame: 6 mos. post treatment ] [ Designated as safety issue: No ]Significant improvement in patient's functional capacity, defined by an Oswestry score difference <10%, in patients given nitrous oxide treatment along with interventional block.
- Opiod intake reduction [ Time Frame: 3 mos. post treatment ] [ Designated as safety issue: No ]Reduction in opioid intake at 3, 6, and 12 months post treatment
- opiod intake reduction [ Time Frame: 6 mos. post treatment ] [ Designated as safety issue: No ]Reduction in opioid intake at 3, 6, and 12 months post treatment
- opiod intake reduction [ Time Frame: 12 mos. post treatment ] [ Designated as safety issue: No ]Reduction in opioid intake at 3, 6, and 12 months post treatment
- biomarkers [ Time Frame: baseline, pre treatment ] [ Designated as safety issue: No ]BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment
- Biomarkers [ Time Frame: 30 days post treatment ] [ Designated as safety issue: No ]BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment
- Biomarkers [ Time Frame: 3 mos. post treatment ] [ Designated as safety issue: No ]BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment
- Biomarkers [ Time Frame: 6 mos. post treatment ] [ Designated as safety issue: No ]BIOMARKERS: IL-1, IL-6, IL-8 in blood samples and epidural lavage samples -baseline and after each treatment
| Estimated Enrollment: | 78 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Entonox
Patients will receive inhaled Entonox along with the interventional block they are scheduled.
|
Other: 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.
Other Name: Nitrous Oxide
|
|
Placebo Comparator: Oxygen
Patients will receive inhaled oxygen along with the interventional block they are scheduled.
|
Other: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Ohio | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Alparslan Turan, M.D. 216-445-9857 turana@ccf.org | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Alparslan Turan, M.D. 216-445-9857 turana@ccf.org | |
| Contact: Gretchen Upton 216-444-3289 uptong@ccf.org | |
| Principal Investigator: | Alparslan Turan, M.D. | The Cleveland Clinic |
More Information
No publications provided
| Responsible Party: | Alparslan Turan, MD, Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT01172600 History of Changes |
| Other Study ID Numbers: | 10-446 |
| Study First Received: | July 27, 2010 |
| Last Updated: | February 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Outcomes Research Consortium:
|
radiating back pain epidural block steroid recurrent low back pain Lumbar Epidural Steroid Block with 3 injections |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Neuralgia Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Peripheral Nervous System Diseases Neuromuscular Diseases Nitrous Oxide Entonox Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Inhalation Anesthetics, General Anesthetics Central Nervous System Depressants Anesthetics, Combined |
ClinicalTrials.gov processed this record on May 23, 2013