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Clinical Trials/NCT04453449
NCT04453449
Completed
Not Applicable

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

Henry Ford Health System1 site in 1 country95 target enrollmentJune 25, 2020

Overview

Phase
Not Applicable
Intervention
Midazolam
Conditions
Lumbar Spine Spondylosis
Sponsor
Henry Ford Health System
Enrollment
95
Locations
1
Primary Endpoint
Number of positive blocks
Status
Completed
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 25, 2020
End Date
October 15, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katherine Nowak

Research Manager

Henry Ford Health System

Eligibility Criteria

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

Arms & Interventions

Sedation

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

Intervention: Midazolam

Outcomes

Primary Outcomes

Number of positive blocks

Time Frame: 8 hours post diagnostic block

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.

Secondary Outcomes

  • Number of false positive blocks(2.5-3 months)

Study Sites (1)

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