NCT04453449

The Effect of Midazolam Sedation on Diagnostic Medial Branch Blocks

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 95 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Lumbar Spine Spondylosis
• Anxiety Generalized

Interventions

Type	Name	Description
DRUG	Midazolam	Midazolam given as a sedative during diagnostic lumbar medial branch block

Timeline

• Start date: 2020-06-25
• Primary completion: 2021-09-01
• Completion: 2021-10-15
• First posted: 2020-07-01
• Last updated: 2022-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study