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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
Results First Received: January 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Supportive Care
Conditions: Low Back Pain
Radiating Pain
Interventions: Other: Entonox
Other: Oxygen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

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.


Participant Flow:   Overall Study
    Entonox   Oxygen
STARTED   39   39 
COMPLETED   39   39 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.

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.

Total Total of all reporting groups

Baseline Measures
   Entonox   Oxygen   Total 
Overall Participants Analyzed 
[Units: Participants]
 39   39   78 
Age 
[Units: Years]
Mean (Standard Deviation)
 70  (20)   73  (16)   71  (18) 
Gender 
[Units: Participants]
     
Female   17   21   38 
Male   22   18   40 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   27   27   54 
African American   12   12   24 
Body mass index 
[Units: Kg/m2]
Median (Inter-Quartile Range)
 30 
 (27 to 35) 
 28 
 (25 to 34) 
 30 
 (26 to 34) 
American Society of Anesthesiologists physical status 
[Units: Participants]
     
I: A normal healthy patient   9   7   16 
II: A patient with mild systemic disease   30   27   57 
III: A patient with severe systemic disease   0   5   5 
Smoking status 
[Units: Participants]
     
Current Smoker   10   9   19 
Previously quit   15   12   27 
Never smoked   14   18   32 


  Outcome Measures
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1.  Primary:   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) ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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) ]

7.  Secondary:   Usage of Opioids   [ Time Frame: 2nd block, typically at 1 month from baseline ]

8.  Secondary:   Usage of Opioid   [ Time Frame: 3rd block, typically at 2 months from baseline ]

9.  Secondary:   Usage of Opioid   [ Time Frame: 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks) ]

10.  Secondary:   Biomarkers   [ Time Frame: baseline - before 1st block ]

11.  Secondary:   Biomarkers   [ Time Frame: before 2nd block, typically at 1 month from baseline ]

12.  Secondary:   Biomarkers   [ Time Frame: before 3rd block, typically at 2 months from baseline ]

13.  Secondary:   Biomarkers   [ Time Frame: 3 months follow-up after last block (maximum of 3 blocks with a typical 1 month interval between blocks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alparslan Turan, MD
Organization: Cleveland Clinic
phone: 216-445-9857
e-mail: turana@ccf.org



Responsible Party: Alparslan Turan, 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