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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alparslan Turan, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01172600
First received: July 27, 2010
Last updated: August 24, 2016
Last verified: August 2016
  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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Change in VAS Pain Score From Baseline to 3 Month Follow-up [ 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) ] [ Designated as safety issue: No ]

    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.


  • Change in VAS Pain Score From Baseline to Before 2nd Block [ Time Frame: At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline ] [ Designated as safety issue: No ]

    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.


  • Change in VAS Pain Score From Baseline to Before 3rd Block [ Time Frame: At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Change in Oswestry Score (% of Disability) From Baseline to 2nd Block [ Time Frame: At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline ] [ Designated as safety issue: No ]
    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.

  • Change in Oswestry Score (% of Disability) From Baseline to 3rd Block [ Time Frame: At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline ] [ Designated as safety issue: No ]
    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.

  • Change in Oswestry Score (% of Disability) From Baseline to 3 Months Follow-up [ 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) ] [ Designated as safety issue: No ]
    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.

  • Usage of Opioids [ Time Frame: 2nd block, typically at 1 month from baseline ] [ Designated as safety issue: No ]
  • Usage of Opioid [ Time Frame: 3rd block, typically at 2 months from baseline ] [ Designated as safety issue: No ]
  • Usage of Opioid [ Time Frame: 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks) ] [ Designated as safety issue: No ]
  • Biomarkers [ Time Frame: baseline - before 1st block ] [ Designated as safety issue: No ]
    BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α

  • Biomarkers [ Time Frame: before 2nd block, typically at 1 month from baseline ] [ Designated as safety issue: No ]
    BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α

  • Biomarkers [ Time Frame: before 3rd block, typically at 2 months from baseline ] [ Designated as safety issue: No ]
    BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α

  • Biomarkers [ Time Frame: 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks) ] [ Designated as safety issue: No ]
    BIOMARKERS: IL-1β, IL-6, IL-10, 1L-17A, IFN-γ, and TNF-α


Enrollment: 78
Study Start Date: January 2011
Study Completion Date: March 2013
Primary Completion Date: January 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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172600

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Alparslan Turan, M.D. The Cleveland Clinic
  More Information

Responsible Party: Alparslan Turan, Alparslan Turan, M.D., The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01172600     History of Changes
Other Study ID Numbers: 10-446 
Study First Received: July 27, 2010
Results First Received: January 5, 2016
Last Updated: August 24, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
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
Entonox
Nitrous Oxide
Anesthetics, Combined
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Inhalation
Anesthetics, General
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on December 09, 2016