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

Basivertebral Nerve Block Performed in Conjunction With Vertebral Augmentation for Anesthesia

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

Study Overview

• Status: Completed
• Conditions: Vertebral Fracture; Vertebral Compression; Vertebra Compression Fracture
• Intervention / Treatment: Procedure: Basivertebral nerve block; Drug: Lidocaine induced basivertebral nerve block

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Port Jefferson, New York, United States, 11777
      • Northwell Health Mather Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Kenny Lien, MD, Northwell Health - Mather Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: nerve block; Kyphoplasty; Vertebral augmentation; Basivertebral nerve block; BVN block; compression fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Spinal Injuries; Back Injuries; Fractures, Bone; Spinal Fractures; Fractures, Compression; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: MTH18-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be made available upon request at the discretion of the primary investigator.

Drug and device information, study documents

• 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