The Effect of Midazolam Sedation on Diagnostic Medial Branch Blocks (MBB)

A Prospective Study Investigating the Effect of Midazolam Sedation on Diagnostic Lumbar Medial Branch Blocks

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Generalized; Lumbar Spine Spondylosis
• Intervention / Treatment: Drug: Midazolam

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 without myelopathy. Patients typically receive two subsequent diagnostic blocks prior RFTC, to ensure that the correct location has been targeted. When patients achieve at least 80% pain relief after both diagnostic blocks, this is considered a positive result and they can proceed to receive RFTC. If patients have positive diagnostic blocks but their RFTC is not successful, this is considered a false positive diagnostic result. This study will determine 1) if a higher number of sedated patients proceed to radiofrequency thermocoagulation (RFTC) than non-sedated patients, and 2) if there are a higher number of false positive results in sedated patients. The hypothesis is that the use of midazolam sedation will increase the number of patients who perceive to have pain relief from their diagnostic block results, resulting in more patients proceeding to RFTC, and that there will be a higher number of false positive results in sedated patients. The primary outcome measure is the number of sedated versus non-sedated patients that have positive block results. A positive result will be calculated by having at least one NRS score that is at least 80% lower than their baseline NRS score in the 8 hours following lumbar MBB. The secondary outcome will be the number of false positive blocks in sedated versus non-sedated patients. After patients achieve 80% relief after each of the two diagnostic lumbar medial branch blocks and proceeds with lumbar RFTC, we will then collect NRS scores 24 hours after both diagnostic Lumbar MBB, and 4 weeks and at 8 weeks after the lumbar RFTC. If a patient has not received at least 50% reduction from their baseline NRS score by 8 weeks, this will be considered a false positive. A 7-point Patient Global Impression of Change (PGIC) score 8 hours after each Lumbar MBB will also be collected, and at 4 weeks and 8 weeks after the lumbar RFTC, and any adverse effects patients experience. In addition, Oswestry Disability Index (ODI) will be collected at 4 and 8 weeks after lumbar RFTC. The results of this study will help guide the use of sedation when performing diagnostic blocks on patients with lumbar spondylosis, in order to reduce the number of false positive blocks.

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Midazolam given as a sedative during diagnostic lumbar medial branch block; Other Names: sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of false positive blocks	The number of false positive diagnostic lumbar medial branch blocks (defined by at least 80% pain relief in the two diagnostic blocks, and then less than 80% pain relief following the subsequent radiofrequency thermocoagulation treatment) in patients who receive midazolam sedation during their diagnostic blocks will be compared to patients who do not receive sedation.	2.5-3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Change-7 (PGIC-7) scores	The PGIC-7 scores of patients who received sedation will be compared to those who did not receive sedation during their diagnostic lumbar medial branch block.	24 hours post diagnostic block; 4 and 8 weeks after radiofrequency thermocoagulation
Oswestry Disability Index (ODI) scores	The ODI scores of patients who received sedation will be compared to those who did not receive sedation during their diagnostic lumbar medial branch block.	4 and 8 weeks after radiofrequency thermocoagulation

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: June 27, 2020
• First Submitted That Met QC Criteria: June 27, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: midazolam; sedation; diagnostic lumbar medial branch block; radiofrequency thermocoagulation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: 14010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes