Basivertebral Nerve Block During Vertebral Augmentation: An Alternative Approach to Intraprocedural Pain Management

Study Overview
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Brief Summary
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The goal of this study is to assess the efficacy of lidocaine basivertebral nerve block as intraprocedural anesthesia during vertebral augmentation procedures.

Detailed Description
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Vertebral compression fractures secondary to osteoporosis can be treated with vertebral augmentation. Since intraprocedural pain is common during vertebral body endplate manipulation, these procedures are often carried out using conscious sedation or general anesthesia. Research has shown that the vertebral endplates are innervated by the basivertebral nerve, which has been successfully targeted via radiofrequency ablation to treat chronic vertebrogenic lower back pain. With this physiology in mind, the investigators will attempt to treated participants with vertebral compression using lidocaine-induced intraosseous basivertebral nerve block as the primary intraprocedural analgesia.

Official Title
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Basivertebral Nerve Block Performed in Conjunction With Vertebral Augmentation for Anesthesia

Conditions
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Vertebral Compression, Vertebra Compression Fracture, Vertebral Fracture

Intervention / Treatment
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* Procedure: Basivertebral nerve block
* Drug: Lidocaine induced basivertebral nerve block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >50 years old Patient must have a diagnosis of osteoporosis on dual energy x-ray absorptiometry (DEXA), Patient must have an acute or subacute single level vertebral compression fracture between T10 - L3 as confirmed via magnetic resonance imaging (MRI) or nuclear medicine bone scan, Patient must have an initial pain score of greater than or equal to five using a standard 0-10 Visual Analog Scale subjective pain score upon initial consultation. Exclusion Criteria: Pathologic compression fracture, such as due to metastatic disease Age >90 years old or <50 years old Pregnancy Diagnosed Anxiety Disorder Diagnosed Depression Disorder Diagnosed Psychotic Disorder Diagnosed Mental Disease Disorder Diagnosed Parkinson's disease/other movement disorders/or cerebellar dysfunction Eastern Cooperative Oncology Group (ECOG) score at baseline prior to compression fracture >1 Back Pain scores at time of initial consult <5, using a standard Visual Analog Scale Illicit drug dependence or abuse Alcohol dependence or abuse

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BVN Block<br>Patients will receive temporary basivertebral nerve block using lidocaine during the vertebral augmentation procedure for osteoporotic compression fracture. | Procedure: Basivertebral nerve block<br>* Temporary intraosseous basivertebral nerve block using lidocaine<br>* Other names: BVN block during vertebral augmentation;Drug: Lidocaine induced basivertebral nerve block<br>* Intraosseous lidocaine basivertebral nerve block<br>* Other names: Lidocaine BVN block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-procedure Pain Score | Subjective pain as measured using a standard Visual Analog Scale (VAS) of 0-10, where 0 represents no pain, and 10 indicates the worst pain of the patient's life. VAS pain scores will be obtained upon preprocedural consultation. | At pre-procedure consultation. | 
| Immediate Post-procedure Pain Score | Subjective pain as measured using a standard Visual Analog Scale (VAS) of 0-10, where 0 represents no pain, and 10 indicates the worst pain of the patient's life. VAS pain scores will be obtained immediately post-procedure. | In the immediate post-procedure period in recover. | 
| One-week Post-procedure Pain Score | Subjective pain as measured using a standard Visual Analog Scale (VAS) of 0-10, where 0 represents no pain, and 10 indicates the worst pain of the patient's life. VAS pain scores will be obtained at one-week post-procedure follow-up in clinic. | At one-week post procedure follow-up. | 
| Immediate Post-procedure Satisfaction Score | Patients will be asked to rate their satisfaction using a subjective Likert scale of 1 - 4, in the immediate post-procedure period during recovery. Satisfaction ratings were defined as follows: 1 = completely dissatisfied, 2 = dissatisfied, 3 = satisfied, 4 = very satisfied. | Assessed at one-week post procedure follow-up. | 
| One-week Post-procedure Satisfaction Score | Patients will be asked to rate their satisfaction using a subjective Likert scale of 1 - 4, at one week clinical follow-up. Satisfaction ratings were defined as follows: 1 = completely dissatisfied, 2 = dissatisfied, 3 = satisfied, 4 = very satisfied. | At one-week post-procedure follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate disturbance | >20% change from baseline heart rate as measured in beats per minute (BPM) | Intraprocedural | 
| Blood pressure disturbance | >20% change from baseline systolic or diastolic blood pressure as measured in mm of Mercury (mmHg) | Intraprocedural | 
| Need for additional anesthesia or sedation | Intraprocedural monitoring for patient pain in real time during the procedure. Need for additional pain or sedative medication such as Fentanyl or Versed, at the discretion of the interventional radiologist performing the procedure. | Intraprocedural | 
| Intraprocedural pain during balloon augmentation | Special attention to patient pain will be assessed during intraprocedural balloon augmentation, as this is often the most painful part of the procedure. Subjective pain as measured using a standard Visual Analog Scale (VAS) of 0-10, where 0 represents no pain, and 10 indicates the worst pain of the patient's life. Additional routine monitoring of pain will take place during the procedure as carried out by the circulating nurse and by the interventional radiologist performing the procedure. | Intraprocedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Basivertebral nerve block, Vertebral augmentation, BVN block, Kyphoplasty, nerve block, compression fracture