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

Vertebral Fracture Clinical Trial

Official title:

Basivertebral Nerve Block Performed in Conjunction With Vertebral Augmentation for Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04774029
• Other study ID #: MTH18-017
• Status: Completed
• Phase: Early Phase 1
• Start date: January 10, 2020
• Est. completion date: May 1, 2020

Study information

• Verified date: February 2021
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Compression
• Spinal Fractures
• Vertebra Compression Fracture
• Vertebral Compression
• Vertebral Fracture

Intervention

Procedure:
• Basivertebral nerve block
Temporary intraosseous basivertebral nerve block using lidocaine

Drug:
• Lidocaine induced basivertebral nerve block
Intraosseous lidocaine basivertebral nerve block

Locations

Country	Name	City	State
United States	Northwell Health Mather Hospital	Port Jefferson	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Heart rate disturbance	>20% change from baseline heart rate as measured in beats per minute (BPM)	Intraprocedural
Secondary	Blood pressure disturbance	>20% change from baseline systolic or diastolic blood pressure as measured in mm of Mercury (mmHg)	Intraprocedural
Secondary	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
Secondary	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