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Ultrasound-guided L5 Dorsal Ramus Block (USGL5DR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03805906
Recruitment Status : Completed
First Posted : January 16, 2019
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
University of British Columbia
Kelowna General Hospital
Information provided by (Responsible Party):
Roderick Finlayson, Montreal General Hospital

Tracking Information
First Submitted Date January 13, 2019
First Posted Date January 16, 2019
Last Update Posted Date September 16, 2020
Actual Study Start Date January 12, 2019
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 15, 2019)
Block accuracy [ Time Frame: Immediately post-injection ]
contrast distribution
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 15, 2019)
  • Performance time [ Time Frame: Perioperative ]
    Performance time as defined by the time the first image is acquired until the time the contrast injection is completed.
  • Number of needle passes [ Time Frame: Procedure ]
    Number of needle passes required to perform block
Original Secondary Outcome Measures
 (submitted: January 15, 2019)
  • Performance time [ Time Frame: Procedure ]
    Performance time as defined by the time the first image is acquired until the time the contrast injection is completed.
  • Number of needle passes [ Time Frame: Procedure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ultrasound-guided L5 Dorsal Ramus Block
Official Title Ultrasound-guided L5 Dorsal Ramus Block: Description and Validation of a Novel Technique
Brief Summary 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients suffering from chronic low back pain thought to involve the L5 dorsal ramus
Condition Pain, Back
Intervention Procedure: L5 Dorsal ramus block
Ultrasound-guided L5 dorsal ramus block
Study Groups/Cohorts Primary group
Ultrasound-Guided L5 Dorsal ramus block
Intervention: Procedure: L5 Dorsal ramus block
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 15, 2019)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date April 30, 2019
Actual Primary Completion Date April 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

-Any consenting patient over 18 years of age with axial low back pain who requires a diagnostic L5 dorsal ramus block.

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03805906
Other Study ID Numbers 2018-19-061-H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Roderick Finlayson, Montreal General Hospital
Study Sponsor Montreal General Hospital
Collaborators
  • University of British Columbia
  • Kelowna General Hospital
Investigators Not Provided
PRS Account Montreal General Hospital
Verification Date September 2020