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

NCT04774029 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: MTH18-017
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vertebral Compression; Vertebra Compression Fracture; Vertebral Fracture

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Heart rate disturbance

  Intraprocedural

• Blood pressure disturbance

  Intraprocedural

• Need for additional anesthesia or sedation

  Intraprocedural

• Intraprocedural pain during balloon augmentation

  Intraprocedural

Study Arms (1)

BVN Block

EXPERIMENTAL

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

Procedure: Basivertebral nerve block; Drug: Lidocaine induced basivertebral nerve block

Interventions

Basivertebral nerve block PROCEDURE

Temporary intraosseous basivertebral nerve block using lidocaine

Also known as: BVN block during vertebral augmentation

BVN Block

Lidocaine induced basivertebral nerve block DRUG

Intraosseous lidocaine basivertebral nerve block

Also known as: Lidocaine BVN block

BVN Block

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health Mather Hospital

Port Jefferson, New York, 11777, United States

Location

MeSH Terms

Conditions

Spinal Fractures; Fractures, Compression

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Kenny Lien, MD

  Northwell Health - Mather Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 26, 2021
• Study Start: January 10, 2020
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)