Pain, BackUSGL5DRNCT03805906
Ultrasound-guided L5 Dorsal Ramus Block
An observational study of Pain, Back, run by Montreal General Hospital at 1 site in Canada.
Trial summary
This study will examine the accuracy of an ultrasound-guided L5 dorsal ramus block technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Back
- What is being tested?
- L5 Dorsal ramus block
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jan 2019to 30 Apr 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suffering from chronic low back pain thought to involve the L5 dorsal ramus
Who may be able to join
- -Any consenting patient over 18 years of age with axial low back pain who requires a diagnostic L5 dorsal ramus block.
Who cannot join
- Inability to consent
- Iodine or lidocaine allergy,
- Pregnancy,
- Coagulopathy (as defined by an INR over 1.4, platelets under 100,000, or a documented bleeding disorder)
- Inability to visualize lumbosacral anatomy during an ultrasound pre- scan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided L5 Dorsal Ramus Block: Description and Validation of a Novel Technique
This study will examine the accuracy of an ultrasound-guided L5 dorsal ramus block technique.
Read the detailed description
The lumbar facet joints have been implicated as a causal factor in 15 to 40% of patients suffering from chronic low back pain. Because physical examination and medical imaging have limited value in determining the source of pain, diagnostic blocks play an important role in the management of this common condition. Blocks of the L5 dorsal ramus (DR) are used to diagnosed pain originating from the L5-S1 facet joint, which is one of the most commonly implicated levels in patients with low back pain. Fluoroscopic guidance, which uses x-rays, is currently the standard imaging modality used to perform this block. Recently, ultrasound guidance has seen increasing use because of its greater accessibility and lack of ionizing radiation. Although USG has been shown to provide a high level of accuracy at other levels, the greater anatomical complexity found at the L5-S1 has hindered the development of a satisfactory L5 DR block technique. In this study the investigators will use fluoroscopic control to examine the accuracy of a novel ultrasound-guided approach to this block.
- Conditions
- Pain, Back
- Being tested
- L5 Dorsal ramus block
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L5 Dorsal ramus blockProcedure or surgery
Ultrasound-guided L5 dorsal ramus block
| Study group | Role | What they receive |
|---|---|---|
| Primary group | Ultrasound-Guided L5 Dorsal ramus block Receives: Procedure: L5 Dorsal ramus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block accuracy
contrast distribution
Measured: Immediately post-injection
Secondary outcomes (2)
Performance time
Performance time as defined by the time the first image is acquired until the time the contrast injection is completed.
Measured: Perioperative
Number of needle passes
Number of needle passes required to perform block
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start12 Jan 2019
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, BackStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Kelowna General Hospital
- Responsible party
- Principal investigator, Roderick Finlayson, Montreal General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805906
- Sponsor's protocol ID
- 2018-19-061-H
- Acronym
- USGL5DR
- Status last verified
- Sep 2020
- First submitted
- 13 Jan 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Etheridge JB, De Villiers F, Venter J, Squire P, Farnquist B, Finlayson RJ. Ultrasound-guided L5 dorsal ramus block: validation of a novel technique. Reg Anesth Pain Med. 2020 Mar;45(3):176-179. doi: 10.1136/rapm-2019-100783. Epub 2019 Oct 25.
PubMed 31653796
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided L5 Dorsal Ramus Block: Description and Validation of a Novel Technique
- ClinicalTrials.gov ID
- NCT03805906
- Acronym / sponsor ID
- USGL5DR / 2018-19-061-H
- Conditions
- Pain, Back
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Montreal General HospitalUniversity, hospital or other
- Collaborators
- University of British Columbia, Kelowna General Hospital
- Study start
- 12 Jan 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 16 Jan 2019 (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.
This study will examine the accuracy of an ultrasound-guided L5 dorsal ramus block technique.
Detailed description
The lumbar facet joints have been implicated as a causal factor in 15 to 40% of patients suffering from chronic low back pain. Because physical examination and medical imaging have limited value in determining the source of pain, diagnostic blocks play an important role in the management of this common condition. Blocks of the L5 dorsal ramus (DR) are used to diagnosed pain originating from the L5-S1 facet joint, which is one of the most commonly implicated levels in patients with low back pain. Fluoroscopic guidance, which uses x-rays, is currently the standard imaging modality used to perform this block. Recently, ultrasound guidance has seen increasing use because of its greater accessibility and lack of ionizing radiation. Although USG has been shown to provide a high level of accuracy at other levels, the greater anatomical complexity found at the L5-S1 has hindered the development of a satisfactory L5 DR block technique. In this study the investigators will use fluoroscopic control to examine the accuracy of a novel ultrasound-guided approach to this block.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary group | – | Procedure: L5 Dorsal ramus blockUltrasound-Guided L5 Dorsal ramus block |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffering from chronic low back pain thought to involve the L5 dorsal ramus
Key inclusion criteria (1 listed)
- -Any consenting patient over 18 years of age with axial low back pain who requires a diagnostic L5 dorsal ramus block.
Key exclusion criteria (5 listed)
- Inability to consent
- Iodine or lidocaine allergy,
- Pregnancy,
- Coagulopathy (as defined by an INR over 1.4, platelets under 100,000, or a documented bleeding disorder)
- Inability to visualize lumbosacral anatomy during an ultrasound pre- scan
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 |
|---|---|---|
| L5 Dorsal ramus blockUltrasound-guided L5 dorsal ramus block | Procedure or surgery | Primary group |
Primary outcome
Block accuracy
Time frame: Immediately post-injection
contrast distribution
2 secondary outcomes
Performance time
Time frame: Perioperative
Number of needle passes
Time frame: Procedure
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 16 Sep 2020.
- Derived from this study: PubMed 31653796Etheridge JB, De Villiers F, Venter J, Squire P, Farnquist B, Finlayson RJ. Ultrasound-guided L5 dorsal ramus block: validation of a novel technique. Reg Anesth Pain Med. 2020 Mar;45(3):176-179. doi: 10.1136/rapm-2019-100783. Epub 2019 Oct 25.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Back, run by Montreal General Hospital at 1 site in Canada.
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 1 inclusion and 5 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 16 Sep 2020. 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 Canada. 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.
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?
Block accuracy (time frame: Immediately post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03805906, which also lists 1 linked publication.
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 16 Sep 2020; AzTrials last refreshed its copy on 6 Nov 2026.