Vertebral CompressionEarly Phase 1NCT04774029
Basivertebral Nerve Block During Vertebral Augmentation: An Alternative Approach to Intraprocedural Pain Management
A Early Phase 1 study testing Basivertebral nerve block and Lidocaine induced basivertebral nerve block in people with Vertebral Compression and Vertebra Compression Fracture, run by Northwell Health at 1 site in United States.
Trial summary
The goal of this study is to assess the efficacy of lidocaine basivertebral nerve block as intraprocedural anesthesia during vertebral augmentation procedures. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Vertebral Compression, Vertebra Compression Fracture, Vertebral Fracture
- What is being tested?
- Basivertebral nerve block and Lidocaine induced basivertebral nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 1 May 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwell Health Mather Hospital
Port Jefferson, New York, 11777
About this study
Official title: 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.
Read the 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.
- Being tested
- Basivertebral nerve block, Lidocaine induced basivertebral nerve block
- Keywords
- Basivertebral nerve block, Vertebral augmentation, BVN block, Kyphoplasty, nerve block, compression fracture
- Medical subject headings
- Spinal Fractures, Fractures, Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basivertebral nerve blockProcedure or surgery
Also called BVN block during vertebral augmentation
Temporary intraosseous basivertebral nerve block using lidocaine
Lidocaine induced basivertebral nerve blockDrug
Also called Lidocaine BVN block
Intraosseous lidocaine basivertebral nerve block
| Study group | Role | What they receive |
|---|---|---|
| BVN Block | Experimental | Patients will receive temporary basivertebral nerve block using lidocaine during the vertebral augmentation procedure for osteoporotic compression fracture. Receives: Procedure: Basivertebral nerve block; Drug: Lidocaine induced basivertebral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At one-week post-procedure follow-up.
Secondary outcomes (4)
Heart rate disturbance
>20% change from baseline heart rate as measured in beats per minute (BPM)
Measured: Intraprocedural
Blood pressure disturbance
>20% change from baseline systolic or diastolic blood pressure as measured in mm of Mercury (mmHg)
Measured: 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.
Measured: 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.
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start10 Jan 2020
- Primary completion1 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral CompressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenny Lien, MD, Principal investigator, Northwell Health - Mather Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774029
- Sponsor's protocol ID
- MTH18-017
- Status last verified
- Feb 2021
- First submitted
- 17 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be made available upon request at the discretion of the primary investigator.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basivertebral Nerve Block Performed in Conjunction With Vertebral Augmentation for Anesthesia
- ClinicalTrials.gov ID
- NCT04774029
- Acronym / sponsor ID
- MTH18-017
- Keywords
- Basivertebral nerve block, Vertebral augmentation, BVN block, Kyphoplasty, nerve block, compression fracture
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BVN Block | Experimental | Procedure: Basivertebral nerve block, Drug: Lidocaine induced basivertebral nerve blockPatients will receive temporary basivertebral nerve block using lidocaine during the vertebral augmentation procedure for osteoporotic compression fracture. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- Pathologic compression fracture, such as due to metastatic disease
- Age >90 years old or <50 years old
- Pregnancy
- Diagnosed Anxiety Disorder
- Diagnosed Depression Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basivertebral nerve blockAlso: BVN block during vertebral augmentationTemporary intraosseous basivertebral nerve block using lidocaine | Procedure or surgery | BVN Block |
| Lidocaine induced basivertebral nerve blockAlso: Lidocaine BVN blockIntraosseous lidocaine basivertebral nerve block | Drug | BVN Block |
Primary outcome
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.
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.
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.
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.
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.
4 secondary outcomes
Heart rate disturbance
Time frame: Intraprocedural
Blood pressure disturbance
Time frame: Intraprocedural
Need for additional anesthesia or sedation
Time frame: Intraprocedural
Intraprocedural pain during balloon augmentation
Time frame: Intraprocedural
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: No. Data will be made available upon request at the discretion of the primary investigator.
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Sickle Cell Disease (SCD) Bone Pain Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenny Lien, MD principal investigator
Northwell Health - Mather Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Basivertebral nerve block and Lidocaine induced basivertebral nerve block in people with Vertebral Compression and Vertebra Compression Fracture, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-procedure Pain Score (time frame: At pre-procedure consultation.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.