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

Primary Purpose

Vertebral Compression, Vertebra Compression Fracture, Vertebral Fracture

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Basivertebral nerve block
Lidocaine induced basivertebral nerve block
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Vertebral Compression focused on measuring Basivertebral nerve block, Vertebral augmentation, BVN block, Kyphoplasty, nerve block, compression fracture

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwell Health Mather Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BVN Block

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Heart rate disturbance
>20% change from baseline heart rate as measured in beats per minute (BPM)
Blood pressure disturbance
>20% change from baseline systolic or diastolic blood pressure as measured in mm of Mercury (mmHg)
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 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.

Full Information

First Posted
February 17, 2021
Last Updated
February 25, 2021
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT04774029
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Compression, Vertebra Compression Fracture, Vertebral Fracture
Keywords
Basivertebral nerve block, Vertebral augmentation, BVN block, Kyphoplasty, nerve block, compression fracture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BVN Block
Arm Type
Experimental
Arm Description
Patients will receive temporary basivertebral nerve block using lidocaine during the vertebral augmentation procedure for osteoporotic compression fracture.
Intervention Type
Procedure
Intervention Name(s)
Basivertebral nerve block
Other Intervention Name(s)
BVN block during vertebral augmentation
Intervention Description
Temporary intraosseous basivertebral nerve block using lidocaine
Intervention Type
Drug
Intervention Name(s)
Lidocaine induced basivertebral nerve block
Other Intervention Name(s)
Lidocaine BVN block
Intervention Description
Intraosseous lidocaine basivertebral nerve block
Primary Outcome Measure Information:
Title
Pre-procedure Pain Score
Description
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.
Time Frame
At pre-procedure consultation.
Title
Immediate Post-procedure Pain Score
Description
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.
Time Frame
In the immediate post-procedure period in recover.
Title
One-week Post-procedure Pain Score
Description
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.
Time Frame
At one-week post procedure follow-up.
Title
Immediate Post-procedure Satisfaction Score
Description
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.
Time Frame
Assessed at one-week post procedure follow-up.
Title
One-week Post-procedure Satisfaction Score
Description
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.
Time Frame
At one-week post-procedure follow-up.
Secondary Outcome Measure Information:
Title
Heart rate disturbance
Description
>20% change from baseline heart rate as measured in beats per minute (BPM)
Time Frame
Intraprocedural
Title
Blood pressure disturbance
Description
>20% change from baseline systolic or diastolic blood pressure as measured in mm of Mercury (mmHg)
Time Frame
Intraprocedural
Title
Need for additional anesthesia or sedation
Description
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.
Time Frame
Intraprocedural
Title
Intraprocedural pain during balloon augmentation
Description
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.
Time Frame
Intraprocedural

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenny Lien, MD
Organizational Affiliation
Northwell Health - Mather Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwell Health Mather Hospital
City
Port Jefferson
State/Province
New York
ZIP/Postal Code
11777
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be made available upon request at the discretion of the primary investigator.

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

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