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

NCT01172600 | Completed Results

• 1 other identifier: 10-446
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain; Radiating Pain

Keywords

radiating back pain; epidural block; steroid; recurrent low back pain; Lumbar Epidural Steroid Block with 3 injections

Outcome Measures

Primary Outcomes (3)

• Change in VAS Pain Score From Baseline to 3 Month Follow-up

  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.

  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)

• Change in VAS Pain Score From Baseline to Before 2nd Block

  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.

  At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline

• Change in VAS Pain Score From Baseline to Before 3rd Block

  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

  At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline

Secondary Outcomes (10)

• Change in Oswestry Score (% of Disability) From Baseline to 2nd Block

  At baseline (before 1st block) and before the 2nd block, typically at 1 month from baseline

• Change in Oswestry Score (% of Disability) From Baseline to 3rd Block

  At baseline (before 1st block) and before the 3rd block, typically at 2 months from baseline

• Change in Oswestry Score (% of Disability) From Baseline to 3 Months Follow-up

  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)

• Usage of Opioids

  2nd block, typically at 1 month from baseline

• Usage of Opioid

  3rd block, typically at 2 months from baseline

Study Arms (2)

Entonox

ACTIVE COMPARATOR

Patients will receive inhaled Entonox along with the interventional block they are scheduled.

Other: Entonox

Oxygen

PLACEBO COMPARATOR

Patients will receive inhaled oxygen along with the interventional block they are scheduled.

Other: Oxygen

Interventions

Entonox OTHER

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.

Also known as: Nitrous Oxide

Entonox

Oxygen OTHER

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.

Oxygen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Low Back Pain; Pain

Interventions

Entonox; Nitrous Oxide; Oxygen

Condition Hierarchy (Ancestors)

Back Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements

Results Point of Contact

• Title: Alparslan Turan, MD
• Organization: Cleveland Clinic

turana@ccf.org

216-445-9857

Study Officials

• Alparslan Turan, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alparslan Turan, M.D.

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 30, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 17, 2016
• Results First Posted: October 17, 2016

Record last verified: 2016-08

Locations

US (1)