Status:
COMPLETED
The Effect of Midazolam Sedation on Diagnostic Medial Branch Blocks
Lead Sponsor:
Henry Ford Health System
Conditions:
Lumbar Spine Spondylosis
Anxiety Generalized
Eligibility:
All Genders
18+ years
Brief Summary
This prospective observational study aims to investigate the effect of midazolam sedation on the diagnostic validity of diagnostic lumbar medial branch block in patients diagnosed with lumbar spondylo...
Detailed Description
This prospective observational study aims to investigate the effects of midazolam sedation on the diagnostic validity of lumbar medial branch blocks in patients diagnosed with lumbar spondylosis witho...
Eligibility Criteria
Inclusion
- Adult patients at least 18 years of age
- History of axial low back pain for at least 3 months
- Indication for bilateral lumbar medial branch block (L3, L4, L5 medial branch nerves)
- Diagnosis of Lumbar Spondylosis without Myelopathy \>4/10 pain on a 0-10 numerical rating scale (NRS)
Exclusion
- Low back pain with radiculopathy symptoms (this is a diagnosis of sciatica and treatment is not with lumbar medial branch block)
- Uncontrolled major depression or other mental health issues causing instability
- Pregnant or lactating women
- \<18 years old
- History of adverse reaction to either midazolam, lidocaine, or bupivacaine
- Focal neurological deficits, cognitive impairments, or memory issues
- Non-English speaking
- Hearing impaired that are unable to understand verbal instructions
- Active Infection
- On Anticoagulation or Antiplatelet Therapy
- History of Clotting Disorder
- Previous Lumbar Medial Branch Block and/or Lumbar Radiofrequency Ablation
Key Trial Info
Start Date :
June 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 15 2021
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04453449
Start Date
June 25 2020
End Date
October 15 2021
Last Update
March 7 2022
Active Locations (1)
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1
Henry Ford Health System
Detroit, Michigan, United States, 48201