The Effect of Midazolam Sedation on Diagnostic Medial Branch Blocks

NCT04453449 | Completed FDA Drug

• 1 other identifier: 14010
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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 spondylosis without myelopathy.

Conditions

Lumbar Spine Spondylosis; Anxiety Generalized

Keywords

midazolam; sedation; diagnostic lumbar medial branch block; radiofrequency thermocoagulation

Outcome Measures

Primary Outcomes (1)

• Number of positive blocks

  The number of positive diagnostic lumbar medial branch blocks (defined by at least 80% pain relief) in patients who receive midazolam sedation during their diagnostic blocks will be compared to patients who do not receive sedation.

  8 hours post diagnostic block

Secondary Outcomes (1)

• Number of false positive blocks

  2.5-3 months

Other Outcomes (2)

• Patient Global Impression of Change-7 (PGIC-7) scores

  24 hours post diagnostic block; 4 and 8 weeks after radiofrequency thermocoagulation

• Oswestry Disability Index (ODI) scores

  4 and 8 weeks after radiofrequency thermocoagulation

Study Arms (2)

No sedation

Patients who will undergo the diagnostic lumbar medial branch blocks without sedation (control group).

Sedation

Patients who will undergo the diagnostic lumbar medial branch blocks with midazolam sedation (treatment group).

Drug: Midazolam

Interventions

Midazolam DRUG

Midazolam given as a sedative during diagnostic lumbar medial branch block

Also known as: sedation

Sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with Lumbar Spondylosis without Myelopathy at either of five study locations (HFMC - Ford Rd, HFMC Main, HFMC West Bloomfield, HFMC Pierson, HFMC - Jackson) from June 1st, 2020 - June 1st, 2021.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

• Patel N, Nowak K, Vaidyanathan A, Milad H, Adlaka K, Rubino C, Vasquez ET, Nerusu L, Rahavard B, Fayed M, Forrest P, Money S, Dwivedi S, Zador L, Haddad R, Khaja D, Sibai N, Aiyer R. The Effect of Sedation on Diagnostic Lumbar Medial Branch Blocks for Facetogenic Low Back Pain: An Observational Study. Pain Physician. 2024 May;27(4):E407-E418.

  PMID: 38805536 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: June 27, 2020
• First Posted: July 1, 2020
• Study Start: June 25, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 15, 2021
• Last Updated: March 7, 2022

Record last verified: 2022-03

Locations

US (1)