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

Back Pain Clinical Trial

— USGSLBB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750436
• Other study ID #: 15-544MUHC
• Status: Completed
• Phase: N/A
• First received: April 17, 2016
• Last updated: March 24, 2017
• Start date: April 25, 2016
• Est. completion date: July 30, 2016

Study information

• Verified date: March 2017
• Source: Montreal General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 30, 2016
• Est. primary completion date: July 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain

Intervention

Device:
• Ultrasound guided
This group will be treated using an ultrasound imaging device
• Fluoroscopy guided
This group will be treated using a fluoroscopy imaging device

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Montreal General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance time	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.	Duration of procedure (less than 20 minutes)
Secondary	Change in pain numerical rating score from baseline	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.	Baseline and 20 minutes after procedure