Clinical trial NCT04774029: Basivertebral Nerve Block During Vertebral Augmentation: An Alternative Approach to Intraprocedural Pain Management
Official title: Basivertebral Nerve Block Performed in Conjunction With Vertebral Augmentation for Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Vertebral Compression
Vertebra Compression Fracture
Vertebral Fracture
Keywords: Basivertebral nerve block
Vertebral augmentation
BVN block
Kyphoplasty
nerve block
compression fracture
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pre-procedure Pain Score
timeFrame: At pre-procedure consultation.
measure: Immediate Post-procedure Pain Score
timeFrame: In the immediate post-procedure period in recover.
measure: One-week Post-procedure Pain Score
timeFrame: At one-week post procedure follow-up.
measure: Immediate Post-procedure Satisfaction Score
timeFrame: Assessed at one-week post procedure follow-up.
measure: One-week Post-procedure Satisfaction Score
timeFrame: At one-week post-procedure follow-up.
Secondary outcomes:
measure: Heart rate disturbance
timeFrame: Intraprocedural
measure: Blood pressure disturbance
timeFrame: Intraprocedural
measure: Need for additional anesthesia or sedation
timeFrame: Intraprocedural
measure: Intraprocedural pain during balloon augmentation
timeFrame: Intraprocedural
Other outcomes:
Locations:
city: Port Jefferson
country: United States
facility: Northwell Health Mather Hospital
state: New York
Study officials:
affiliation: Northwell Health - Mather Hospital
name: Kenny Lien, MD
role: PRINCIPAL_INVESTIGATOR
References: