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Completed

NCT Number: NCT04774029

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

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

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Key information

Conditions

Vertebral Compression Back Injuries Fractures, Bone Fractures, Compression Spinal Fractures Spinal Injuries Vertebra Compression Fracture Vertebral Fracture Wounds and Injuries

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Northwell Health Mather Hospital

Port Jefferson, New York, 11777, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basivertebral nerve block

Procedure

Temporary intraosseous basivertebral nerve block using lidocaine

Other names: BVN block during vertebral augmentation

Lidocaine induced basivertebral nerve block

Drug

Intraosseous lidocaine basivertebral nerve block

Other names: Lidocaine BVN block

Primary outcomes

  1. Pre-procedure Pain Score

    Time frame: At pre-procedure consultation.

    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.

  2. Immediate Post-procedure Pain Score

    Time frame: In the immediate post-procedure period in recover.

    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.

  3. One-week Post-procedure Pain Score

    Time frame: At one-week post procedure follow-up.

    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.

  4. Immediate Post-procedure Satisfaction Score

    Time frame: Assessed at one-week post procedure follow-up.

    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.

  5. One-week Post-procedure Satisfaction Score

    Time frame: At one-week post-procedure follow-up.

    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 outcomes

  1. Heart rate disturbance

    Time frame: Intraprocedural

    >20% change from baseline heart rate as measured in beats per minute (BPM)

  2. Blood pressure disturbance

    Time frame: Intraprocedural

    >20% change from baseline systolic or diastolic blood pressure as measured in mm of Mercury (mmHg)

  3. Need for additional anesthesia or sedation

    Time frame: Intraprocedural

    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.

  4. Intraprocedural pain during balloon augmentation

    Time frame: Intraprocedural

    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.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

Basivertebral Nerve Block Performed in Conjunction With Vertebral Augmentation for Anesthesia

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2021
Registry last updated
Feb 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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