Overview

This trial is active, not recruiting.

Conditions low back pain, radiating pain
Treatments entonox, oxygen
Sponsor The Cleveland Clinic
Start date July 2010
End date June 2016
Trial size 72 participants
Trial identifier NCT01172600, 10-446

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose supportive care
Arm
(Active Comparator)
Patients will receive inhaled Entonox along with the interventional block they are scheduled.
entonox Nitrous Oxide
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.
(Placebo Comparator)
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.

Primary Outcomes

Measure
Pain relief
time frame: 30 days post treatment
Pain Relief
time frame: 3 mos. post treatment
Pain Relief
time frame: 6 mos. post treatment

Secondary Outcomes

Measure
Functional capacity
time frame: 30 days post treatment
Functional Capacity
time frame: 3 most post treatment
Functional Capacity
time frame: 6 mos. post treatment
Opioid intake reduction
time frame: 3 mos. post treatment
Opioid intake reduction
time frame: 6 mos. post treatment
Opioid intake reduction
time frame: 12 mos. post treatment
biomarkers
time frame: baseline, pre treatment
Biomarkers
time frame: 30 days post treatment
Biomarkers
time frame: 3 mos. post treatment
Biomarkers
time frame: 6 mos. post treatment

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Effect of Nitrous Oxide in Treating Neuropathic Pain: A Pilot Study in Chronic Low Back Pain Patients
Principal investigator Alparslan Turan, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.