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

NCT02750436 — Not applicable, Completed, 40 participants, Montreal General Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

A Prospective Randomized Comparison of Ultrasound Versus Fluoroscopic Guidance for Sacral Lateral Branch Blocks

Registry	NCT02750436, acronym USGSLBB
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	40 (Actual)
Sponsor	Montreal General Hospital (Other)
Conditions	Back Pain
Interventions	Ultrasound guided, Fluoroscopy guided (Device)
Dates	start 2016-04-25, primary completion 2016-07-30, completion 2016-07-30, first posted 2016-04-25, last updated 2017-03-27
Locations	1 site in Canada

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Ultrasound guided	Experimental	Device: Ultrasound guided	Ultrasound guided sacral lateral branch block
Fluoroscopy guided	Active comparator	Device: Fluoroscopy guided	Fluoroscopically guided sacral lateral branch block

Ultrasound guided (Device), also known as Ultrasound guided sacral lateral branch block: This group will be treated using an ultrasound imaging device
Fluoroscopy guided (Device), also known as Fluoroscopically guided sacral lateral branch block: This group will be treated using a fluoroscopy imaging device

+Outcome measures

Primary outcomes

Performance time [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 outcomes

Change in pain numerical rating score from baseline [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.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Montreal General Hospital	Montreal, Quebec	Canada

+Investigators

Roderick J Finlayson, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre

My Notes

Public

To Read Reading Read