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

NCT ID: NCT04774029

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2020-05-01

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.

Conditions

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Vertebral Compression Vertebra Compression Fracture Vertebral Fracture

Keywords

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Basivertebral nerve block Vertebral augmentation BVN block Kyphoplasty nerve block compression fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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BVN Block

Patients will receive temporary basivertebral nerve block using lidocaine during the vertebral augmentation procedure for osteoporotic compression fracture.

Group Type EXPERIMENTAL

Basivertebral nerve block

Intervention Type PROCEDURE

Temporary intraosseous basivertebral nerve block using lidocaine

Lidocaine induced basivertebral nerve block

Intervention Type DRUG

Intraosseous lidocaine basivertebral nerve block

Interventions

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Basivertebral nerve block

Temporary intraosseous basivertebral nerve block using lidocaine

Intervention Type PROCEDURE

Lidocaine induced basivertebral nerve block

Intraosseous lidocaine basivertebral nerve block

Intervention Type DRUG

Other Intervention Names

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BVN block during vertebral augmentation Lidocaine BVN block

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenny Lien, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health - Mather Hospital

Locations

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Northwell Health Mather Hospital

Port Jefferson, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MTH18-017

Identifier Type: -

Identifier Source: org_study_id