Ultrasound-guided L5 Dorsal Ramus Block (USGL5DR)

• ClinicalTrials.gov Identifier: NCT03805906
• Recruitment Status: Completed
• First Posted: January 16, 2019
• Last Update Posted: September 16, 2020
• Sponsor: Montreal General Hospital
• 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

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.

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

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

• Current Responsible Party: Roderick Finlayson, Montreal General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Montreal General Hospital
• Original Study Sponsor: Same as current

Collaborators

• University of British Columbia
• Kelowna General Hospital

• Investigators: Not Provided
• PRS Account: Montreal General Hospital
• Verification Date: September 2020