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A Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks (USGSLBB)

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ClinicalTrials.gov Identifier: NCT02750436
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Roderick Finlayson, Montreal General Hospital

Brief Summary:
Sacral lateral branch blocks are used for the diagnosis and treatment of sacroiliac joint pain. This study will compare ultrasound and fluoroscopy guidance for sacral lateral branch blocks. Outcomes examined will include performance times and success rates.

Condition or disease Intervention/treatment Phase
Back Pain Device: Ultrasound guided Device: Fluoroscopy guided Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks
Actual Study Start Date : April 25, 2016
Actual Primary Completion Date : July 30, 2016
Actual Study Completion Date : July 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Ultrasound guided
Ultrasound guided sacral lateral branch block
Device: Ultrasound guided
This group will be treated using an ultrasound imaging device
Other Name: Ultrasound guided sacral lateral branch block

Active Comparator: Fluoroscopy guided
Fluoroscopically guided sacral lateral branch block
Device: Fluoroscopy guided
This group will be treated using a fluoroscopy imaging device
Other Name: Fluoroscopically guided sacral lateral branch block




Primary Outcome Measures :
  1. Performance time [ Time Frame: Duration of procedure (less than 20 minutes) ]
    Block performance time will be measured from the time the first image is acquired, until the last injection is completed. Typical performance time are expected to be less than 20 minutes for both groups.


Secondary Outcome Measures :
  1. Change in pain numerical rating score from baseline [ Time Frame: Baseline and 20 minutes after procedure ]
    The extent of anesthesia provided by the blocks will be assessed by probing structures known to be innervated by the lateral branches and L5 posterior root. Two pain measurements will be undertaken, before and 20 minutes after the injections. Pain reports will be quantified by using a numerical rating score.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any consenting patient over 18 years of age, undergoing a diagnostic sacral lateral branch block for suspected sacroiliac joint related pain.

Exclusion Criteria:

  • Inability to consent, iodine or lidocaine allergy, pregnancy, coagulopathy (as defined by an international normalized ratio over 1.4, platelets under 100,000, or a documented bleeding disorder) and inability to visualize the target areas necessary for sensory testing (posterior superior iliac spine, dorsal aspect of SIJ) under ultrasound guidance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750436


Locations
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Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4
Sponsors and Collaborators
Montreal General Hospital
Investigators
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Principal Investigator: Roderick J Finlayson, MD McGill University Health Center

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Responsible Party: Roderick Finlayson, Professor Department of Anesthesia, Montreal General Hospital
ClinicalTrials.gov Identifier: NCT02750436     History of Changes
Other Study ID Numbers: 15-544MUHC
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms